Evidence based medicine – A clinical experience on Ayurveda Medicine

Full text

Traditional systems of medicine are fast emerging as viable alternatives to
modern medical science. Further, in recent years the emphasis on botanicals
as source for drug discovery and development has been realized globally.
Added to this, the safer profile of herbal drugs combined with their low costs
make them ideal targets for newer drugs. As in the modern system of medicine,
viz. allopathy, herbal drugs form an inseparable part of the management of
various disorders. The concept of scientific validation of the basis of traditional
uses of herbal medicines has given birth to a new concept of reverse
pharmacology, and interactions between traditional and modern systems of
medicine are being increasingly encouraged. Recent Trends in Herbal Drug
Research and Therapy showcases some of these crucial and emerging issues
relating to herbal drugs. This compilation is a judicious combination of
research and conventional aspects on the subject of herbal drugs, their
pharmacology and therapeutic applications. Some very relevant general and
systemic pharmacological as well as toxicological aspects have been
highlighted by some of the leading experts in this field. The book will be of
interest to students, scientists, teachers and other health professionals in the
area of pharmacology, toxicology and allied health sciences.
Arunabha Ray, MD, Ph.D, FAMS, is Professor and Head, Department of
Pharmacology, Vallabhbhai Patel Chest Institute, University of Delhi. He
graduated from the University of Calcutta and completed his postgraduate
and doctoral studies from the University of Delhi. He has been involved in
teaching and research in basic and clinical pharmacology both in India and
abroad for the past three decades. During his illustrious career he has been
the recipient of several academic awards and honors, and has authored more
than 150 research publications, several invited book chapters and reviews,
one textbook in pharmacology and edited two books.
Kavita Gulati, M.Sc, Ph.D, is Associate Professor, Department of
Pharmacology, Vallabhbhai Patel Chest Institute, University of Delhi. She did
her graduation and postgraduaion from the All India Institute of Medical
Sciences and did her doctorate from the Faculty of Medicine, University of
Delhi. She has been the recipient of several honors and distinctions and has
more than 70 publications to her credit, which include research papers,
chapters in books, invited reviews and monographs. She is also the co-editor
of two books on Pharmacology.
S-25, Green Park Extension, Uphaar Cinema Market
New Delhi-110016, India • E-mail: info@ikinternational.com
Editors
Editors:

RECENT ADVANCES IN
Herbal Drug
Research and Therapy

RECENT ADVANCES IN
Herbal Drug
Research and Therapy
ARUNABHA RAY
Professor and Head
Dept. of Pharmacology
Vallabhbhai Patel Chest Institute
University of Delhi
KAVITA GULATI
Associate Professor
Dept. of Pharmacology
Vallabhbhai Patel Chest Institute
University of Delhi
I.K. International Publishing House Pvt. Ltd.
NEW DELHI • BANGALORE

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Herbal drugs are rapidly emerging as effective alternative forms of pharmacotherapy.
Medicinal plants area focus and thrust area of biomedical research and natural
products have contributed to many significant leads in the drug development. India
with its rich biodiversity is a vast source of traditional medicinal products, which
have been used by practitioners of traditional systems of medicine over several
hundreds of years. Recently, there has been a renewed interest in the research with
phytopharmaceuticals, and modern methods are being increasingly applied in the
drug discovery and development process.
Recent Advances in Herbal Drug Research and Therapy effectively amalgamates
some of the crucial issues involved in herbal drug research and development and
emphasizes their impact on rational pharmacotherapeutics. This is a unique collection
of articles by experts from the academia, pharmaceutical industry and regulatory
agencies from India and abroad. Some of the basic as well as applied aspects in
herbal drug research and therapy have been aptly highlighted in the various chapters
of this publication. The traditional aspects of such agents as well as some of the
modern viewpoints and concepts have been dealt with by the experts in a very
proficient manner. A considerable amount of attention has been given to the selection
of the topics integrating the traditional with modern medical concepts, thus making it
a book of considerable contemporary interest in the current context of drug
development.
The editors of this book have done a commendable job in putting together
some of the full articles based on the high quality presentations made during the
International Symposium on Herbal Drug Research and Therapy organized by the
Vallabhbhai Patel Chest Institute in December 2006, at Delhi. The updated information
provided on a wide array of topics in the area of herbal drugs should be a treat for
the students, scientists, professionals from traditional and modern systems of
medicine. This is a unique collection of twenty six chapters dealing with a wide
spectrum of issues relating to the subject matter and will be a prize possession for
the reader. Most notable feature in the book is the inclusion of chapters like Quality
Control and Standardization of Herbal Drugs; Ethical Guidelines for Herbal Drug
Research; Herbogenomics, Pharmacovigilance with herbal remedies; Herb-Drug
Interactions and some recent developments in specific areas of therapy. I congratulate
the editors for this stupendous effort and wish this book all the very best.
Dr. V.K. Vijayan
Director
Vallabhbhai Patel Chest Institute
University of Delhi, Delhi-110 007
1
Foreword

Traditional systems of medicine mostly rely on the use of plant based products
for the treatment of several intractable diseases. Evidence based medicine has
resulted in the emergence of herbal drugs as complimentary and sometimes
even alternative forms of pharmacotherapy. The use of both monoherbals and
polyherbals are gaining popularity as useful adjuncts along with modern medical
strategies, and the application of state of the art scientific methodology and
techniques in the research of phytopharmaceuticals is being encouraged at all
levels. This has resulted in meaningful interactions between traditional and
modern systems of medicine and concepts like ‘reverse pharmacology‘ have
been strongly advocated in herbal drug research. The academia, the
pharmaceutical industry and the regulator – all have made substantial
contributions in the promotion of herbal drug research and therapy. A prime
reason in the renewed interest generated in herbal drugs has been the stringent
guidelines in the global regulatory scenario, thereby making drug discovery
and development from indigenous sources all the more important. India is a
rich source of medicinal plants, some of which have been used over centuries
in traditional systems of medicine viz. Ayurveda, Unani, Siddha, etc. There is a
dire need for the proper scientific validation of these well documented effects
in the national health interest and adoption of newer techniques in such drug
development is the order of the day. Pharmacological and toxicological studies
are being carried out systematically as per regulatory guidelines for the promotion
of herbal medicines, which has immense pharmacoeconomic implications in
developing countries.
Recent Advances in Herbal Drug Research and Therapy is a sincere attempt
in this direction. The book is a unique compilation of chapters from leading
national and international experts in different aspects of the subject matter, and
consists of both research as well as review articles. This is a sequel of an
International Symposium on Herbal Drug Research and Therapy held by the
Vallabhbhai Patel Chest Institute, University of Delhi, where several renowned
specialists participated and projected their valued opinions on this subject matter
of considerable contemporary importance. Both conventional as well as latest
concepts in the area have been highlighted throughout the compilation by
pharmacologists, toxicologists, herbalists, clinicians and biomedical researchers
from both traditional and modern systems of medicine.
The opening chapter of the book deals with the current status of herbal
drug research in India from a global perspective with specific emphasis on the
banes and boons of this aspect. Issues like quality control of herbal drugs,
1
Preface

ethical considerations for herbal drugs, herb-drug interactions, safety issues
and pharmacovigilance and the pharmaceutical industry perspective are discussed
in detail. Needless to mention these topics are of great interest for professionals
from the academia, industry and regulatory authorities.
Herbal drugs have a significant impact on cardiorespiratory disorders, and
the next section deals with some of the recent developments in cardiac as well
as respiratory disorders like hypertension, cardioprotection, stroke, thrombosis,
etc. This group of diseases is a major contributor to morbidity and mortality
worldwide, and the findings presented will have an impact on the therapeutics
of these conditions. Some of the next few chapters focus on the role of
herbal drugs in CNS mediated conditions like neuroprotective and
psychoprotective agents, anti-stress or adaptogenic agents. The brain has a
controlling influence on many peripheral organ systems and the neuroregulatory
role of some of these plant based products provides exciting data. Metabolic
disorders like diabetes mellitus and its complications pose a major health problem
and are rapidly emerging as one of the leading causes of premature deaths; a
chapter in the book also deals with the potential use of herbal drugs in the
treatment of diabetes and its complications. Gastrointestinal conditions require
special attention as according to Ayurveda most of the diseases originate from
the GI tract. A few chapters have been dedicated to the gastroprotective (peptic
ulcer) and hepatoprotective effects of important herbal agents. The anti-leukemic
and anti-tumor potential of some herbs have been elaborated in a couple of
exquisitely written chapters, and this may provide important leads to the
development of effective agents in these incurable diseases. Occupational and
environmental toxicology is a leading cause of organ damage and the next few
chapters deal with the role of phytopharmaceutical agents against radiation and
heavy metal induced toxic manifestations, and their impact on human health.
Finally, genetic factors are being increasingly recognized as being responsible
for some of the differential effects seen with drugs and this concept has been
applied to herbal drugs as well. A chapter has exclusively been devoted to
Herbogenomics to highlight this very important and relevant aspect of herbal
drugs.
Taken together, this book is a unique compilation of some of the most
relevant and contemporary issues in the area of herbal drug research,
development and therapy. The book will be a valuable asset for professionals
from the academia, industry and regulatory authorities, as well as aspiring
students of biomedical research.
We gratefully acknowledge the cooperation and support of all the
contributors and authors who devoted their valuable time and effort in the
conceiving and making of this publication.
Editors
viii Preface

Foreword v
Preface vii
Editors xiii
1. Quality Control and Standardisation of Single and
Poly Herbal Drugs: Challenges and Opportunities 1
Dr. O.P. Agarwal
2. Ethical Guidelines for Herbal Drugs in India 9
Nandini K. Kumar
3. Meandering Safety of Natural Health Products 20
Pulok K. Mukherjee, M. Venkatesh, Atul Wahile and
Pradip Paul
4. Herbal Drug Research and Therapy—Industry Experience 35
S.R. Dasgupta
5. Pharmacovigilance of Herbal Remedies 40
Madhumita Banerjee and P. Sen
6. Evidence Based Medicine—A Clinical Experience on 49
Ayurveda Medicine
Pratip K. Debnath, Achintya Mitra, Jayram Hazra,
Srikanta Pandit, Tuhin Kanti Biswas, Utpalendu Jana,
Tapan K. Ghosh, Tapas Sur, Biswajeet Auddy and
P.K. Prajapati
7. Herb-drug Interactions: A Matter of Great Concern 66
Ophthalmic Medicines—A Review
P. Sen and Madhumita Banerjee
8. Herbogenomics: A New Discipline of Herbal Drug 74
Therapy
C. Girish, S.C. Pradhan and C. Adithan
1
CONTENTS

9. Biology of Cardiovascular Disease and Herbal Medicines 88
P. Dasgupta
10. Ocimum sanctum: Its Role in Cardioprotection in 97
Psychological Stress
S.K. Maulik
11. Resurgence of Herbals for the Treatment of Hypertension 103
Kashif Hanif and Ram Raghubir
12. Advancements in the New Anti-thrombotic Drug 130
Development
Prem Prakash, William R Surin, Manoj Kumar Barthwal
and Madhu Dikshit
13. Indigenous Knowledge of Medicinal Plant to New 164
Approach for Drug Development: Revisited
Preeti Dohare and Madhur Ray
14. Role of Ayurveda in Respiratory Disorders 177
G.S. Laveker
15. Cough: Pharmacological Approaches to a Physiological 189
Response
K. Ravi
16. Newer Insights into the Mechanisms of Action of Some 201
Herbal Adaptogens
Kavita Gulati and Arunabha Ray
17. From Ginkgo biloba to a Neuro-Protective and 219
Psycho-active Drug Lead NV-31
Dr. Shyam Sunder Chatterjee
18. Liver Disorders and Herbal Drug Development 239
Kala Suhas Kulkarni
19. Evaluating the Therapeutic Potential of Natural 264
Products as New Drugs for Peptic Ulcer Disease
Gautam Palit and Shawon Lahiri
20. From Concept to Reality in Herbal Medicine: 271
Zingiber officinale as Potential Antidiabetic Herbal
Drug with Specific 5-Hydroxytryptamine Receptors
as the Target
Ramesh K. Goyal and Snehal S. Patel
xContents

21. Exploring Plant Materials for Anti-inflammatory and 293
Anti-Leukemic Potential
Soma Ray and J. Rajan Vedasiromoni
22. Studies on Anti-Tumor Potential of Tea 335
(Camellia sinensis) Polyphenols
Triparna Sen, Shuvojit Moulik, Anindita Dutta,
Shamik Das, Aniruddha Banerji, Madhumita Roy
and Amitava Chatterjee
23. Modulation of Radiation Inflicted Tissue Injuries in Swiss 363
Albino Mice by a Semipurified Fraction Prepared from
High Altitude Plant Podophyllum Hexandrum
Manju Lata Gupta, Savita Verma and Sanghmitra Sankhwar
24. Terpenes: Penetration Enhancers for Transdermal 379
Drug Delivery
Bharti Sapra, Subheet Jain and A.K. Tiwary
25. Arsenic Toxicity: Biochemical Effects, Mechanism of 401
Action and Strategies for the Prevention and Treatment
by Chelating Agents and Herbal Extracts
S.J.S. Flora, Megha Mittal, Richa Gupta and S.C. Pant
26. Potential Therapeutic Entities from Plants for 449
Various Ocular Disorders
T. Velpandian and Rajani Mathur
Index 461
Contents xi

Arunabha Ray, MD, Ph.D, FAMS, is Professor and Head, Department of
Pharmacology, Vallabhbhai Patel Chest Institute, University of Delhi. He
graduated from the University of Calcutta and completed his postgraduate and
doctoral studies from the University of Delhi. He has been involved in teaching
and research in basic and clinical pharmacology both in India and abroad for
the past three decades. During his illustrious career he has been the recipient
of several academic awards and honors, and has authored more than 150
research publications, several invited book chapters and reviews, one textbook
in pharmacology and edited two books.
Kavita Gulati, M.Sc, Ph.D, is Associate Professor, Department of
Pharmacology, Vallabhbhai Patel Chest Institute, University of Delhi. She did
her graduation and postgraduaion from the All India Institute of Medical Sciences
and did her doctorate from the Faculty of Medicine, University of Delhi. She
has been the recipient of several honors and distinctions and has more than 70
publications to her credit, which include research papers, chapters in books,
invited reviews and monographs. She is also the co-editor of two books on
Pharmacology.
1
Editors

6
Evidence Based MedicineA Clinical
Experience on Ayurveda Medicine
Pratip K. Debnath*, Achintya Mitra*, Jayram Hazra*, Srikanta Pandit**,
Tuhin Kanti Biswas**, Utpalendu Jana**, Tapan K. Ghosh**,
Tapas Sur**, Biswajeet Auddy***, and P. K. Prajapati¡
ABSTRACT
Indian knowledge base on healthcare modalities through Ayurveda is acceptable
to traditional families of India. The whole gamut of remedial measures encircle
with two major aspects prevention and maintenance of healthier lifestyle in one
hand and curing the disease on the other. Most of the information are on experience
based with observational clinical pharmacology. To match with the need for
global acceptance evidence base scientific documentation is the essential
component like safety, efficacy and standardization. Fresh pulmonary tuberculosis
patients after diagnosis four regimen (HRZE) was administered in conjuction
with Aswagandha (Stress Com, Dabur, 1 cap twice daily), Silajit (Dabur, 1 cap
twice daily) and Chawyanprash (10 g twice daily, Dabur) for 28 days. Before and
after blood isoniazid and pyrazinamide were estimated along with IgA and IgM.
Sputum bacterial load was estimated 0' day to 28 days at different time intervals.
Bacterial load started becoming free from 17 days and completed within 26 days.
While in ATD group it starts from 26 days and on 29 days fifty per cent patients
also remained positive. The quality of life assessment, body weight change along
with haematological picture was significantly different.
Indian knowledge and practice on indigenous medical systems, art, science,
culture, music, etc. was very rich. It explores the oldest civilization in the
world so far. Indigenous drugs are being used in Ayurveda are well
accepted and practiced by the Indian community which is best suited for
the rural people of India. Its experience based pharmacodynamics are
well known to the local healers. Presence of medicinal plants and other
natural products in socio-cultural events and rituals are already recognized
to the traditional families of India.[1]
*National Research Institute of Ayurveda for Drug Development, 4 CN Block, Sector V,
Bidhan Nagar, Kolkata-700 091.
**Clinical Research Unit, J. B. Roy State Ayurvedic Medical College & Hospitals, 170-172,
Raja Dinendra Street, Kolkata-700 004.
***Natreon Inc (India), CL 17A, Salt Lake City, Kolkata 700 091.
¡Department of Rasashastra, IPGT & R, Gujrat Ayurveda University, Jamnagar.
E-mail: dr.pkdebnath@gmail.com

Pratip K. Debnath et al.50
Evidence based medicine is important to generate data that will support
health professionals to use Ayurveda in the main stream of healthcare.
Many centers in India have been involved in validating the Ayurvedic
concepts of health, disease and treatment. It has also tried for re-evaluating
the potentials of Ayurvedic remedies as adjuncts or ads on therapy, which
plays an important role in tertiary medical healthcare. The scientific
validation of Ayurveda principles and treatment on clinical models require
to be evaluated in the modern established methodologies. The strategies
of biomedical models for new drug development may not be tenable for
Ayurvedic medicine. Moreover, it is being used in continuity with
experience based observation on symptoms since centuries, which may
be considered as the natural form of clinical trials. Obviously, the stringent
evaluation procedure on toxicological study is not recommended. For
the regulatory purpose, acute and sub-acute toxicological study to be
followed according to WHO Guidelines for Toxicity Investigations of Herbal
Medicine. In 1991, there had been proposed the new strategies program
for the evaluation of Ayurvedic drugs which was forwarded and
nomenclature by Dr. A. B. Vaidya in 2002 as ‘Reverse Pharmacology.’
The Ministry of Health & Family Welfare, Government of India in their
National Health Policy on ISM drugs, 2002 had incorporated “Reverse
Pharmacology” strategies to be adopted for scientific evidence and
validation of ISM drugs.
REVERSE PHARMACOLOGY: A NOVEL APPROACH ON AYURVEDIC
RESEARCH
Drug development and research on Ayurveda necessitates moderation,
as screening procedure to intricate orthodox biomedical guidelines is time
consuming and involves huge finance in R & D. To delineate the process,
reverse pathway of conventional screening procedure ebb out[2] human
trials are taken first to validate the literature backed efficacy (Figure 1).
Acute and sub-acute toxicity (maximum 6 months), experimental studies,
phase I and phase II clinical trials are conducted to meet the regulatory
formalities. The promise of this novel path on Ayurvedic drug research
was designed and termed “Reverse Pharmacology.[3] Reverse Pharmacology
became official through National Health Policy[4] of ISM & H, 2002. The
best way for searching reverse pharmacology of Ayurvedic drugs can be
observed with the scheme mentioned below and is followed by almost
all the government research organization[5] like ICMR, CSIR, AYUSH,
etc. In December 2007, ICMR had started advance center on Reverse
Pharmacology at the Medical Center, Kasturba Gandhi Health Foundation,
Mumbai.

Evidence Based MedicineA Clinical Experience 51
Synthetic Drugs
(12-15 yrs)
Crude Drug
Active Principle
Animal Study
Toxicological Study Human Trial
Ayurvedic Drugs
(2-3 yrs)
Active Principle Crude Drug
Standardization
Animal Study
Toxicological Study
Figure 1: Reverse Pharmacology for Drug Development[2, 3]
OBSERVATIONAL CLINICAL STUDY ON KULEKHARA (
Hygrophila
spinosa
) ON IRON DEFICIENCY ANEMIA
Iron deficiency anemia (IDA) is most common and severe nutritional
deficiency affecting more than 200 million people worldwide. Indian
scenario is most gloomy; more than 70% women suffer from IDA and the
incidence increases to 88% during pregnancy. Iron supplement along with
corrections of underlying cause is the only wayout. Iron salt therapy
encounters severe to moderate adverse reactions as such acceptance and
agreeability is not uniform. In Ayurveda, Louha bhasma, specially processed
iron preparations are widely used by the physicians. Kulekhara (Hygrophila
spinosa) a vegetable plant native to West Bengal is very popular among
the rural people for correction of anemia used as fresh juice or as vegetable.
Conjectural use with efficacy prompted to the Department of Science &
Technology, Government of West Bengal to make it evidence based with
estimation of hemoglobin and complete hemogram. The outcome of the
study can be utilized for public healthcare.
In above-mentioned clinical trial 402 (registered 473) patients comprising
rural, urban and hospitalized (male 156, female 246) with manifestation
of mild to moderate anemia (Hb 7–10 g/dl), aged between 11 and 50+
years had been completed. They were administered fresh leaf juice (15–
20 ml) from local collection. Ethical committee pointed out how to
determine the fixed dose. Thereafter, juice was prepared in the laboratory
and supplied in a bottle with preservative and sugar for 7 days regimen
(15 ml twice daily). The results are summarized in Tables 1 and 2. The
present study confirmed the continuous use of kulekhara in iron deficiency
anemia. In another studies, the effect of kulekhera was compared with
louha bhasma alone or in combination, in both clinical and experimental

Pratip K. Debnath et al.52
module of iron deficiency anemia assessed by hematological study, serum
iron, serum ferritin and serum iron binding capacity.[4]
TABLE 1: EFFECT OF KULEKHARA ON HEMOGLOBIN, TOTAL RBC COUNT AND PCV
Parameters Before Treatment After Treatment Per cent Increase
(0 day) (30 days) (%)
Hb g/dl 8.37 ± 0.04 11.22 ± 0.07* 34
Total RBC 3.78 ± 0.16 4.34 ± 0.12* 14.8
PCV % 31.11 ± 1.43 37.83 ± 0.88* 21.6
*Statistically significant p < 0.001.
How kulekhara helps in the promotion of hemoglobin is a very interesting
phenomenon. The chlorophyll molecule of kulekhara bears similarities with
hemoglobin in their molecular structure. The function of both is the electron
transfer to maintain the dynamics to be formed as chemical energy. The
water molecule plays a key role. There is every possibility that in kulekhara
the magnesium containing plant protein concentration is more.[5, 6] To
delineate the exact mechanism, in-depth study is essential.
TABLE 2: WELL BEING RESPONSE ON CLINICAL SIGN AND SYMPTOMS ON IRON
DEFICIENCY ANAEMIA
Sign/Symptoms Before Treatment After Treatment* Per cent Decrease
(0 day) (30 days) (%)
Lassitude 2.91 ± 0.25 2.00 ± 0.24 –31.2
Fatigue 3.00 ± 0.23 1.92 ± 0.22 –36.0
Dizziness 3.23 ± 0.25 2.07 ± 0.23 –35.9
Insomnia 2.60 ± 0.22 1.70 ± 0.21 –34.5
Pallor 2.87 ± 0.20 1.81 ± 0.18 –36.9
Oedema 2.42 ± 0.13 1.42 ± 0.13 –41.3
Angular stomatitis 3.00 ± 0.23 1.90 ± 0.21 –36.6
Glossitis 2.90 ± 0.25 2.00 ± 0.23 –31.0
*Statistically significant p < 0.01.
BIO-EQUIVALENCE STUDY OF PLANT PRODUCT “TRIPHALA” ON
CLINICAL SETTINGS
Triphala is an age old Ayurvedic preparation commonly used as laxative
available in the market mostly in powder form. The well known
formulation is prepared by combining the pericarp of the fruits of Haritaki
(Terminalia chebula), Amlaki (Phyllanthus emblica) and Bivitaka (Terminalia
bivitaka), in equal proportion.[6] The popular use as laxative, detoxifying
agent, eye care, skin care and above all as rejuvenator for its rasayana
activity. To establish its clinical validity along with bio-equivalence potency
the formulation was standardized by HPTLC using Gallic acid as marker
compound. After proper screening, 160 patients in the age group between
15–75 years, of either sex, were divided in to four groups. One group

Evidence Based MedicineA Clinical Experience 53
served as control (placebo), other two groups were given different brand
of triphala preparation purchased from market (M1 and M2). The standard
group was administered in house (IH) prepared triphala powder. To every
patient 2.5 g twice daily were administered for 30 days. Patients were
supplied doses form sachet for 7 days at a time. Weekly observations
were recorded on subjective and objective parameters on bowel
movements.[7]
Effectiveness of treatment was compared with respective drugs on
bowel movements and well being compared with normal control group.
The parameters selected to observe bowel movement were amount of
stool, frequency, undigested food, consistency, color, odour and presence
of mucus. Similarly, observations on well being scale were recorded on
concentration, appetite, thirst, sleep, hyperacidity, digestion and physical
strength in arbitrary scale (Table 3, 4, 5).
TABLE 3: EFFECT OF DIFFERENT “TRIPHALA” FORMULATION ON WELL BEING
SCALE*
Groups Mental Sleep Appetite Digestion Physical
Concentration Strength
Control (Placebo) 1.70 ± 0.26 1.80 ± 0.27 1.56 ± 0.21 1.63 ± 0.19 1.57 ± 0.20
Triphala (M1) 1.70 ± 0.26 2.00 ± 0.29 2.00. ± 0.21 1.90 ± 0.17 1.50 ± 0.22
Triphala (M2) 1.81 ± 0.20 1.80 ± 0.24 1.60 ± 0.16 1.80 ± 0.20 1.70 ± 0.21
Standard (IH) 1.70 ± 0.21 1.80 ± 0.25 1.80 ± 0.20 1.80 ± 0.13 1.60 ± 0.16
TABLE 4: EFFECT OF TRIPHALA ON BOWEL MOVEMENT
Groups Amount Stool Frequency Undigested Color Consistency
(gm) Per day Food Stool Stool
Control (Placebo) 178.3 ± 17.42 2.10 ± 0.33 0.433 ± 0.16 0.066 ± 0.06 2.10 ± 0.17
Triphala (M1) 235.0 ± 21.14*** 1.30 ± 0.15* 0.10 ± 0.10 0.0 ± 0.0 2.90 ± 0.10 **
Triphala (M2) 240.0 ± 19.43 1.10 ± 0.10* 0.10 ± 0.10 0.0 ± 0.0 2.70 ± 0.15*
Standard (IH) 240.0 ± 19.43*** 1.30 ± 0.15* 0.10 ± 0.10 0.0 ± 0.0 2.90 ± 0.10**
Results are mean ± SE (n = 40)
* < 0.05, **p < 0.01, ***p < 0.001, when compared with normal group.
TABLE 5: EFFECT OF TRIPHALA ON BOWL HABITS AND ASSOCIATED SYMPTOMS
Groups Odor of Mucous of Flatulence in Belching in Abdominal Pain
Stool Stool Stomach Stomach in Stomach
Control (Placebo) 0.50 ± 0.16 1.03 ± 0.28 0.96 ± 0.28 0.26 ± 0.14 0.30 ± 0.15
Triphala (M1) 0.20 ± 0.13 0.40 ± 0.16* 0.50 ± 0.16* 0.10 ± 0.10 0.00 ± 0.00
Triphala (M2) 0.20 ± 0.13 0.30 ± 0.15* 0.30 ± 0.15* 0.10 ± 0.10 0.10 ± 0.10
Standard (IH) 0.10 ± 0.10 0.30 ± 0.15 0.20 ± 0.16* 0.10 ± 0.10 0.10 ± 0.10
Results are means ± SE (n = 40).
*p < 0.05, when compared with normal group.
Mixed response were observed with different preparation of “triphala”.
In house triphala was found superior in the improvement of stool color,

Pratip K. Debnath et al.54
consistency while content of undigested food and frequency decreased.
Associated symptoms were also improved with well-being. The superiority
of in-house formulation may be due to the process of preparation, where
seeds of all the three fruits were discarded. In marketed product the
process of preparation is unknown.[8]
QUALITY ASSURED BIO-ACTIVITY STUDY OF
ASWAGANDHA
(
Withania somnifera
) ON PULMONARY TUBERCULOSIS
Quality control of any herbal/Ayurvedic preparation needs
standardization, safety and efficacy to meet the quality assurance. In India
most of the small scale Ayurvedic pharmaceutical preparations suffer from
quality assurance. Global attention has been drawn towards natural
products/Ayurvedic medicine and post-marketing surveillance
(pharmacovigilance) for herbal drugs has been started. This is in spite of
the fact that traditionalists of India consider herbal drugs as safe, time
tested and well documented as per classics. This information does not
satisfy the global acceptance criteria due to lack of evidence with latest
methods. For quality control, Good Manufacturing Practice (GMP)
accredited pharmaceuticals have to maintain R & D. standards. Ayurvedic
pharmaceuticals are not prepared to make the change over to meet this
regulatory procedure.[9]
0.000
0.010
0.020
0.030
0.040
0.050
0.060
0.070
2.776 3.358 3.853
4.681
5.284
5.793
6.228
7.517 7.886
9.045
10.706
14.653
2.00 4.00 6.00 8.00 10.00 12.00 14.00
Minutes
600.00
500.00
400.00
300.00
200.00
100.00
0.00
0.983
2.363
?????
2.863
3.183
0.617
HPLC d ata of Aswagandha (Stresscom-D abur)
5.00 10.00
Minutes
Figure 2: HPLC study of different Aswagandha products
Aswagandha (Withania somnifera) is one of the most popular Ayurvedic
plant product widely used as singly or in combination. On evaluation,

Evidence Based MedicineA Clinical Experience 55
wide range of research publications are available on cultivation, marker
compound determination, chemical and experimental evaluation adopting
different models with special attention to, adaptogenic, anti-aging,
nootropic, anti-stress effects to substantiate its potential as rasayana and
rejuvenator.[10]
Besides that, claims are made that Aswagandha is a potential
immunomodulator drug of plant origin.[11] It had already drawn attention
in the west mind in consequence the export already gained accelerated
escalation. On 7th November, 2006, USFDA for the first time approved
herbal green tea extract containing ointment from Japan for its time tested
clinical use. The FDA also issued documentation and manufacturing
guidelines for herbal drugs, phyto marking support of the extract of herbal
preparation.[12]
Most Ayurvedic pharmaceutical companies, irrespective of small,
medium and large size have brought out Aswagandha preparation in the
market, either as rejuvenator, anti-stress or immunomodulator
substantiated with experimental findings on macrophages, phagocytes,
carbon clearance and anti-oxidant activity. Clinical study on the drug to
promote immune status is scanty. Attempts were being made to compare
locally grown Aswagandha powder and marketed product (Stresscom-
Dabur) manufactured by reputed GMP certified, R&D backed
pharmaceuticals for their efficacy in pulmonary tuberculosis.
OH O
H
OCH
3
CH
3
HC
3
HO
CH
3
O
OH
CHO
23 38 6
Mol. Wt. 470.61
Withaferin-A
0
100
200
300
400
500
600
700
–0.13 –0.03 0.07 0.17 0.28 0.38 0.47 0.57
1withaferinA
4
AU
700
600
500
400
300
200
100
0
–0.13 –0.03 0.07 0.17 0.28 0.38 0.47 0.57
12withaferinA
4
Stresscom Aswagandha
Figure 3: Chemical structure of Aswagandha & HPLC study

Pratip K. Debnath et al.56
Freshly diagnosed 60 pulmonary tuberculosis patients were included
with sputum AFB positive and were divided into three groups. All patients
received standard Anti-tubercular drug regimen (HRZE). In two groups,
add-on therapy of different preparation of Aswagandha with ATD were
started and continued for one month. After one month as usual ATD
drugs were continued according to WHO scheduled. Sputum bacterial
load were assessed at different time intervals up to one month. Blood
pictures, body weight change, ESR were the objective parameters were
also recorded (Tables 7, 8). The quality of life of the patients was
determined on well being arbiter scale along with estimation of
immunoglobulin (IgA, IgM).
Before to start the clinical study both the Aswagandha preparations were
standardized on HPLC and HPTLC finger printing with marker
compound Withaferin-A. The amount of withaferin-A were comparable
(Figures 2, 3). In the efficacy study, StressCom (Dabur), a defined drug
formulation, was found superior in that there was early removal of bacterial
load by shifting to the negativity and change in immunoglobulin status.
Human safety is also assessed on the liver function and kidney functions.
TABLE 6: EFFECT OF ASWAGANDHA ON SUBJECTIVE PARAMETERS ON
PULMONARY TUBERCULOSIS PATIENTS
Subjective* ATD ATD + Aswagandha ATD + Stresscom
Parameters 0' d 30' d 0' d 30' d 0' d 30'd
Anorexia 2.71 ± 0.45 1.81 ± 0.12 2.50 ±.0.31 0.25 ±.0.12 2.80 ±. 0.32 0.31 ±.0.14
Cough with 2.68 ±.0.69 1.32 ± 0.23 2.71 ±..0.59 0.30 ±.0.31 2.71 ±. 0.68 0.11 ±.0.12
production
Loss of body 2.80 ±.0.68 0.80 ±.0.61 2.32 ±. 0.62 0.44 ±.0.23 2.75 ±. 0.72 0.50 ±. 0.23
weight
Debility & 2.74 ±. 0.43 1.10 ±.0.37 2.80 ±. 0.81 0.34 ±.0.13 2.69 ±. 0.58 0.21 ±.0.41
weakness
*Lower the score better the finding.
TABLE 7: EFFECT OF ASWAGANDHA ON OBJECTIVE PARAMETERS ON
PULMONARY TUBERCULOSIS PATIENTS
Objective P E R C E N T C H A N G E
Parameters ATD ATD + Aswagandha ATD + Stresscom
Hemoglobin% 104.32 ±. 9.37 119.71 ±. 1.32 118.21 ±. 1.32
ESR 86.94 ±. 2.34* 24.23 ±. 3.47 21.21 ±. 3.41
IgA 92.51 ±. 3.12* 77.19 ±. 3.82 64.31 ±. 4.21
IgM 108.42 ±. 2.31 154.01 ±. 7.24 162.01 ±. 8.21
Absolute Lymphocyte 114.74 ±. 7.52 116.9 1 ±. 11.15 121.03 ±. 8.92
Body Weight 104.57 ±. 0.59 108.21 ±. 0.95 109.41 ± 0.83
*ESR and Immunoglobulin (IgA) followed the decreasing pattern.

Evidence Based MedicineA Clinical Experience 57
TABLE 8: PER CENT SPUTUM BACTERIAL LOAD SHIFT IN PATIENTS WITH
PULMONARY TUBERCULOSIS
Day of Evaluation ATD ATD + Aswagandha ATD + Stresscom
0 Day 0/100* 0/100 0/100
14 0/59.9 0/36.8 0/34.4
21 0/31.6 0/11.4 0/10.2
24 0/26.4 50/7.2 60/6.8
27 0/16.3 100/0 100/0
30 Day 40/12.9 100/0 100/0
*n/n Per cent patient with sputum negative/Per cent bacterial load.
The sputum bacterial load shifted to negativity between 24 and 27 day
when along with ATD different preparation of Aswagandha administered
as add on therapy.
MOLECULES OF METALS AND MINERALS IN AYURVEDA: THE
INTERIOR SCIENCE FOR HEALTH AND DISEASES
Nature being the greatest economist had not provided the metals and
minerals in living system without any function. Presence of microelements
in human system was not fully explored. It needs to be emphasized that
elements are not equally distributed in living system. It is believed that
the mineral drugs or herbo-mineral preparations provide quick relief with
minimum doses.[13] However, there are many apprehensions about the
safety of the mineral and herbo-mineral preparation due to improperly
prepared bhasmas, which may produce ill effects. Certain studies although
indicated that the bhasmas are safe but substantiation with scientific
information is not readily available. Some in vitro and in vivo studies
conducted by pharmacologists found minerals and metals to be toxic.
Most of the time similar confirmations are not available. Moreover, the
samples used in those studies are from the commercially available
preparations. One must look into the manufacturing process and the
quality control of such products. Earlier, in home scale manufacturing the
quality control was maintained by the experienced Vaidyas. However,
small-scale and large-scale manufacturing SOPs are not fully standardized.
Hence, these procedural irregularities have led to the blaming of the
Ayurvedic system and is not in good scientific spirit. A recent report has
highlighted this issue.[14]
STUDIES ON BHASMAS AND MERCURY COMPOUND MAKARADHWAJA
Mercury is known to mankind for a long time.[15] The process of mercury
amalgamation for gold recovery has been employed for the last 2000
years.[16] Aristotle and Theophrastus in 300 BC mentioned that liquid
silver (also known as quick silver) is obtained by rubbing cinnabar with
vinegar in a copper mortar and pestle.[17, 18] Diseriodes in 1st century AD

Pratip K. Debnath et al.58
stated that mercury could be obtained by heating cinnabar with charcoal
in an iron pot. It is one of the most toxic metals. It is toxic in every form,
but it depends on the compound. The degree of toxicity depends on the
actions on critical target organ.[19] The natural mercury compound is
Cinnabar. It is an amalgam of mercury and sulphur. In Indian medicine
Ayurveda, Unani and Siddha sublimate of mercury (HgCl2 and HgSO4)
is used orally which initially affects the mucous membrane of gastro-
intestinal tract followed by renal failure.[20, 21]
Makaradhawaja is a well known Ayurvedic mineral preparation
containing mercury, sulphur and gold and is used in continuity through
the ages. The inclusion in the therapeutic modalities relates with the
evolution of life. On the basis of philosophical background and scientific
reasoning their uses were very intricate in Ayurveda. The term
Makaradhwaja bears a close resemblance to and symbolizes with the power
of vitality and rejuvenation.
The Makaradhwaja, a product, crystalline in texture, looks like cinnabar
and signifies emblem of Makara.[22] Makara is a fabulous creature, its
anterior half resembles a crocodile, while its posterior half looks like
aquatic animal fish. Makara is regarded as half fish and half crocodile.
Water is the universal life essence and the primordial element, with the
greatest creative power. Crocodile lives in most large rivers of the world
and became the symbol of water thus, symbolizing the life protecting
power with both fertility and fecundity. The drug which carries the flag
of Makara symbolizing the activity is known as Makaradhawaja.[23]
Naturally, occurring Cinnabar or mercuric sulphide symbolize virtues of
fish and crocodile representing reproductive-cum-creative power. The
drug was actually prepared by the Ayurvedic Physicians where gold is
taken with mercury then sulphur after special processing shodhana/samaskar
is added and triturated in stone mortar and pestle black mixture is
produced and is ready for sublimation on sand bath for 12 hours at variable
temperature.[24]
In Indian mythology Siva is the symbol of creature and mercury is the
agency he employed. As such for the creation Hara (Shiva) and Gouri
(Parvati) fusion is essential. Mercury is symbolizing with semen of Siva
and Sulphur is the raja of Parvati. When Hara Gouri fusion is there creation
starts. Surprisingly, this correlation could be interlinked with the
preparation of Makaradhwaja. During preparation one part gold, eight
parts mercury and sixteen parts sulphur are added to prepare the raw
material for sublimation.[25] While on drug preparation, mercury is
extracted from Cinnabar. Naturally occurring Cinnabar is amalgam of
sulphur with other trace elements. Moreover, mercury has got natural
affinity to gold. And since ancient times, in gold extraction mercury is
being used. The ratio of mercury and gold is always 8: 1 by weight. The
amalgamation depends on the co-ordination number with ratio.24 It is

Evidence Based MedicineA Clinical Experience 59
surprising how the ancient scientists without knowing the co-ordination
number fixed this ratio of mercury and gold for the preparation of
Makaradhawaja.[26]
When these crystals are pulverized it becomes like red vermilion. When
the fine powder is transformed into fine enough then the nano-particulate
is formed which is known as Anu Makaradhawaja.[27] It is thought that
the atomized form turns to a living form like soul and thought to be the
best drug to save life from death and decay. In the early thirties of the
last century it was marketed by Merck (Germany) and Bengal Chemical,
(India). Mercury and gold are the noble metals and composed of five
elements (Boma, Marut, Teja, Apa and Prithivi) of cosmos integrated with
total creative power.
Wisdom is universal and percolates to knowledge base with the
scientific evidence. Now, due to technological advancement it becomes
possible to detect minute amount of elements. Makaradhawaja contains
organic material—the source may be from nature or during the process
of shodhana the amalgamation had been taken place. Presence of
microelements and organic material in all bhasma preparation are evident.
It is speculated that during the process of interaction with plants products
new organo-metalic molecule is formed with the there are in number of
molecules toxicity.[26]
RECENT RESEARCHES
Most controversial metals like mercury, lead and gold bhasma preparation
were reported to be devoid of toxicity even on 100 times more therapeutic
doses. Histopathological studies on liver, kidney, heart, lungs brain, and
on testis revealed no appreciable change and the safety index were very
high. Iron bhasma contains many essential elements (Cu, Zn, Mn, Mg, Si,
Cr, Co, etc.) and could increase haemoglobin regeneration efficiency and
bio-availability[4], Similarly gold bhasma contains several microelements
(Fe, Al, ,Cu, Zn, Co, MG, Ca, As, Pb) which could stimulate immunostatus
significantly by increasing macrophage phagocutosis and anto-oxidant
activity in animals[28] calcium preparations like pearl, coral and conch
bhasma provide many new insights on the therapeutic use of natural
calcium.[29] Pearl bhasma (mukta) showed hypoglycemic activity,
antioxidant activity, along with anti-ulcer and anti-secretory action in
experimental animals. It protected exercise induced increase in heart rate
in normal volunteers.[29]
The absorption, distribution and excretion of mercury and its
compounds vary considerably on the chemical form of the metals. Mercurial
inorganic salts are less absorbed (15%) than organic ones (80%). Presence
of metals like zinc, cadmium, calcium, manganese in gut influences the
absorption of inorganic mercurials.[30] Mercurous salts are not used clinically

Pratip K. Debnath et al.60
for its toxic components. The inorganic mercurial do not pass the blood
brain barrier or placenta.[31] After administration of Makaradhwaja within
a short period some energetic feeling was obvious.
SAMPLE INFORMATION
Sample Name: MKDG Acquired By: System
Sample Type: Unknown Date Acquired: 9/20/2007 4:37:13 pm
Vial: 1 Acq. Method Set: DBP 2006
Injection #: 1 Date: Processed: 9/20/2007 5:03:04 PM
Injection Volume: 20.00 ul Processing Method: Shilajit
Run Time: 20.0 Minutes Channel Name Wvin Ch 1
Sample Set Name Proc. Chnl, Descr: PDA 240.0 nm
TABLE 9: EFFECT OF MAKARADHAWAJA ON NORMAL VOLUNTEERS AND
CHRONIC RENAL FAILURE
Parameters Normal Volunteers Ch. Renal Failure
Before After Before After
Haemoglobin 14.98 ± 0.64 15.12 ± 0.60 9.02 ± 1.80 9.36 ± 1.58
Blood urea 16.86 ± 4.35 15.91 ± 1.88 111.95 ± 17.42 114.0 ± 21.31
S. creatinine 0.89 ± 0.19 1.69 ± 0.15 8.62 ± 1.11 8.84 ± 1.13
Blood sugar 81.70 ± 18.10 73.50 ± 5.14 93.05 ± 18.68 93.80 ± 11.88
S. cholesterol 189.13 ± 21.04 189.83 ±16.50 185.05 ±23.15 182.40 ±21.11
S. albumin 4.49 ± 0.39 3.96 ± 0.37 4.78 ± 0.42 4.02 ± 0.41
S. globulin 2.03 ± 0.45 1.9 ± 0.22 2.21 ± 0.47 2.02 ± 0.51
Alkaline phosphatase 8.99 ± 1.62 12.91 ± 1.93 9.23 ± 1.73 13.93 ± 1.98
Acid phosphatase. 0.772 ± 1.62 1.263 ± 1.93 0.89 ± 1.81 1.32 ± 2.01
SGOT 19.20 ± 2.83 21.00 ± 3.07 37.12 ± 3.81 45.62 ± 3.87
SGPT 16.90 ± 4.59 33.00 ± 11.82 30.14 ± 5.62 34.13 ± 12.91
Sodium 137.53 ± 2.64 139.16 ± 1.85 140.71 ± 3.48 142.57 ± 4.02
Potassium 2.78 ± 0.25 2.63 ± 0.23 2.87 ± 0.31 2.53 ± 0.32
Results are expressed as Mean ± SD
TABLE 10: EFFECT OF MAKARADHAWAJA ON IMMUNOGLOBULINE PROFILE
ON NORMAL VOLUNTEERS AND CHRONIC RENAL FAILURE
Group IgG IgA IgM
Before After Before After Before After
Normal 1058.3 ± 1075.0 ± 193.3 ± 203.3 ± 127.7 ± 128.3 ±
Volunteers 66.8 45.0 33.4 46.6 24.8 33.5
Chronic 1060.0 ± 1070.0 ± 190.5 ± 188.5 ± 121.2 ± 122.0 ±
Renal 73.6 67.7 24.6 23.9 24.6 25.1
Failure (CRF)
CRF + 9000.0 ± 995.00 ± 259.0 ± 277.0 ± 103.0 ± 113.0 ±
Makara- 105.4 106.6 86.9 90.4 18.8 33.3
dhawaja
Results are expressed as Mean ± S.E.

Evidence Based MedicineA Clinical Experience 61
Administration of Makaradhwaja at 120 mg twice daily for 1 month on
volunteers and patients of chronic renal failure did not show appreciable
toxic effect following assessment of serum urea, serum creatinine, micro
albumin and liver function test. Exploiting of new knowledge, new
technologies approaches to validate the ancient knowledge base may
prove beneficial. The study was conducted at the Department of
Nephrology, Institute of Medical Sciences, Banaras Hindu University
under close supervision of Professor Rana Gopal Singh in collaboration
with Department of Rasashastra.[24, 32]
LOUHA BHASMA CLINICAL STUDY
In-house prepared louha bhasma was standardized on chemically. Iron
concentration was measured by conventional method, atomic absorption
spectrometry (AAS), energy dispersive X-ray spectral study (EDX), infra-
red spectral study (IR), XRF, analysis of particle size, HPLC, HPTLC.
Louha bhasma of different putas (50,100,150) were administered 250 mg/
day for 60 days to iron deficiency anaemia patients. Assessment criteria
included general examination, subjective and objective criteria were
100
100
59.14
95.14
68.21
88.64
0
20
40
60
80
100
Normal
Louha Bhasma
Fefol
Groups
Percentage Improvent of
Hemoglobin
IgA mg/dl
219.3 212.78
247.47
212.39
180
200
220
240
260
Louha B hasma Fefol
Gr oups
0 Day
60 Day
Serum , Ferrit in Level ng/ dl
30.18 23.59
71.2
49.13
0
20
40
60
80
Louha Bhasma Fefol
Groups
0 Day
60 Day
IgG mg/dl
1545.07
1672.5
1642.36 1673.73
1450
1500
1550
1600
1650
1700
Louha Bhasma Fefol
Groups
mg/dl
0 Day
60 Day
IgM mg/dl
165.35 159.29
199.54 159.27
0
50
100
150
200
250
Louha Bhasma Fefol
Groups
mg/dl
0 Day
60 Day

Pratip K. Debnath et al.62
hematological, biochemical, immunological metabolic study, functional
tolerance studies on normal volunteers after pre-clinical study in
experimental anemia and toxicity study were done. The improvement on
biochemical and hematological parameters are comparable with Fefol.
With edge over on immunoglobulins after louha bhasma is apparent while
Fefol is devoid. An improvement of it Louha bhasma is superior than
fefol as it also take care of immune process which is very common in iron
deficiency anaemia.
Studies on Swarnabhasma on Motor Neurone Disease
In motor neurone disease (MND), there was significant improvement in
neurological pain, weakness of limbs, muscle wasting, diminished strength
was regaining and gradualo loss of weight was seen in completed 8
patients. In patients of upper respiratory tract infection (URTI) in
completed 6 patients there was improvement in recurrent attack of cough,
soar throat, burning sensation of eyes and gradual weight loss. SOD
activity in serum interms of percent NADH oxidation was significantly
reduced. There was no appreciable change in serum SGOT, SGPT, creatinine
and blood urea.[28]
TABLE 11: EFFECT OF SWARNABHASMA (GOLD PREPARATION) ON MOTOR
NEURONE DISEASE
Symptoms Before Treatment After 90 days
Neuralgic Pain 1,25 ± 0.54 0.77 ± 0.18*
Weakness both limbs 1.50 ± 0.56 0.51 ± 0.18*
Muscle wasting 2.25 ± 0.49 1.25 ± 0.29*
Diminished strength 2.25 ± 0.47 0.63 ± 0.32**
Inability to walk/move 1.13 ± 0.54 0.62 ± 0.32
Muscle rigidity 0.51 ± 0.37 0.25 ± 0.16
Tremor 0.75 ± 0.49 0.25 ± 0.17
Gradual loss of weight 2.63 ± 0.37 0.87 ± 0.35*
*P< 0.005. n = 8.
Initial Exploratory Observational Pharmacology on Human Stress
Adaptation
In human stress, Withania somnifera (Aswagandha) defined samples (by
courtesy Indian Herbs, Saharanpur) was studied with 1.5 g reduced to
500 mg capsule twice daily and was compared with other four rasayan
drugs Centella asiatica (Madukparni), Ocimum sanctum (Tulsi), Acorus calmus
(Bacha) and Valariana wallichi (Tagara).[33, 34] In total, 50 patients were
allocated for intervention in each group. On an average 10-15% patients
were dropped out in first follow up. In some of them it was estimated to
be improvement on treatment.[35] All the stressed patients were subjected
for initial experience based exploratory observational clinical pharmacology

Evidence Based MedicineA Clinical Experience 63
and followed up on every month for two months for stress adaptation.
In every group the dropouts were apparent after one month follow up.[36]
There were, however, lacuna in the statement for reporting in randomized
clinical trials.[37] The results showed encouraging rasayana activity in
biomedical nomenclature.
TABLE 12: EFFECT OF RASAYAN PLANTS ON THE INITIAL EXPLORATORY
OBSERVATIONAL PHARMACOLOGY ON STRESS ADAPTATION
Parameters Withania Centella Ocimum Acorus Valarian Average
n somnifera asiatica sanctum calamus wallachi change
31 35 35 35 33
Stress 36.5 31.5 27.5 18.9 22.5 27.3
Anxiety 38.1 32.4 34.2 23.3 25.8 30.7
Depression 32.9 31.9 30.8 22.5 20.9 27.8
Adjustment 35.2 35.5 25.1 22.8 20.2 27.7
Neuroticism 34.9 26.2 23.2 16.8 16.2 23.4
Memory 20.1 32.4 19.9 13.7 15.3 20.9
Attention 25.5 27.8 33.9 9.2 13.8 22.8
Concentration 35.4 20.4 30.8 15.1 11.2 23.3
Total Score 258.6 237.8 225.4 144.3 145.9
CONCLUSION
Herbs and heavy metals are essential components of Ayurveda and its
holistic approach. The heavy metals when processed with herbs are highly
effective. There is information that during processing a new molecule is
formed. The combination of single metal or mineral bhasma is required in
smaller doses. It may be the rate limiting factor for efficacy and prevention
of toxicity. Home made herbo-mineral preparations can be administered
for any period irrespective of the duration as required. Their use produces
quick results as compared to herbal preparation only. The standard
operational procedure (SOP) was maintained by the traditional Ayurvedic
physicians themselves for quality control. It is, therefore, difficult to know
about the reports on safety and efficacy, but their use in continuity with
observational experiences demands appreciation. In Ayurveda, those that
are toxic materials are grouped separately and before use proper shodahan
and/or samaskara is indicated and must be done judiciously, as per the
norms. However, on large-scale manufacturing for commercial purposes,
great care has to be taken to alter to the prescribed norms as mentioned
in classical texts of Ayurveda. Innovative medical technology can play a
crucial role in amalgamating the traditional concepts of Ayurveda with
modern medicine.
Professor M.S. Baghel, Director, IPGTR, Gujarat Ayurveda University
for his permission to utilize the informatics. Dr. Runa Ayddy of Natreon
Inc (India), CL 17A, Salt Lake City, Kolkata, 700091 for their help and co-
opration for HPLC studies, Dr. B.P. Shaw Professor and Dr. P.C. Tripathi,

Pratip K. Debnath et al.64
Reader, P G Institute of Ayurvedic Education & Research at SVSP, Kolkata.
Professor Rana Gopal Singh, Department of Nephrology and Professor
C.B. Jha, Department of Rasashastra Institute of Medical Sciences, Banaras
Hindu University. Professor Anjan Bhattacharya and Dr. Rajlakshmi Pai,
Department of Agricultural Chemical for their help in HPTLC studies.
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