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Observational research on the effect of an Ayurvedic treatment protocol in patients of hereditary pancreatitis

Authors:
  • VCP Cancer Research Foundation
  • VCP Cancer Research Foundation, Dehradun

Abstract and Figures

Background: Hereditary pancreatitis (HP) is a chronic and recurrent inflammatory disorder caused by genetic abnormalities, often accompanied by severe symptoms and complications. Conventional treatments offer limited relief but fail to halt disease progression. An Ayurvedic Treatment Protocol has been reported to be effective in treating various types of pancreatitis. Objectives: This observational clinical study is aimed at assessing the efficacy of a year long Ayurvedic treatment protocol (ATP) in mitigating attack frequency and intensity in Hereditary Pancreatitis patients. Materials & Methods: The study enrolled 151 patients across diverse age groups and genders, subjecting them to a comprehensive Ayurvedic treatment protocol at a specialized center. The protocol incorporated Metal-Based Ayurvedic Formulation (MBAF) named Amar, alongside supportive Ayurvedic compounds and dietary adjustments. Patients underwent pre- and post-treatment evaluations involving interviews, medical records, blood tests, radiological imaging, and symptom assessments. Notably, pancreatic enzyme use was discontinued prior to initiating Ayurvedic treatment. Results: Among 151 patients, 88 completed the year long ATP, resulting in significant enhancement of their quality of life. There was a marked 98.7% reduction in emergency hospitalizations and a notable 92.8% decrease in attack frequency (p < 0.0001). Radiological assessments indicated pancreatic health stabilization, while no adverse effects were reported, highlighting the intervention’s safety and tolerability. Conclusion: The study furnishes promising evidence supporting the efficacy and safety of ATP, especially the MBAF, in managing Hereditary Pancreatitis. The observed decline in attack frequency, absence of adverse effects, and stabilization of pancreatic health underscore the potential of Ayurvedic medicine. Subsequent research, including randomized controlled trials, is warranted to substantiate these findings and elucidate underlying mechanisms.
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Journal of Ayurveda and Integrative Medicine 15 (2024) 100913
0975-9476/© 2024 The Authors. Published by Elsevier B.V. on behalf of Institute of Transdisciplinary Health Sciences and Technology and World Ayurveda
Foundation This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Observational research on the effect of an Ayurvedic treatment protocol in
patients of hereditary pancreatitis
Vaidya Balendu Prakash
a
,
*
, Shikha Prakash
b
, Neha Negi
b
, Sneha Tiwari Sati
a
a
VCPC Research Foundation, Prakash Villa, Danpur Area, Rudrapur, Uttarakhand, India
b
Padaav A Specialty Ayurvedic Treatment Centre, Ratanpura, Gadarpur, Udham Singh Nagar, Uttarakhand, India
ARTICLE INFO
Keywords:
Ayurveda
Hereditary pancreatitis
Metal-based ayurvedic formulation
Rasa-shastra
ABSTRACT
Background: Hereditary pancreatitis (HP) is a chronic and recurrent inammatory disorder caused by genetic
abnormalities, often accompanied by severe symptoms and complications. Conventional treatments offer limited
relief but fail to halt disease progression. An Ayurvedic Treatment Protocol has been reported to be effective in
treating various types of pancreatitis.
Objectives: This observational clinical study is aimed at assessing the efcacy of a year long Ayurvedic treatment
protocol (ATP) in mitigating attack frequency and intensity in Hereditary Pancreatitis patients.
Materials & Methods: The study enrolled 151 patients across diverse age groups and genders, subjecting them to a
comprehensive Ayurvedic treatment protocol at a specialized center. The protocol incorporated Metal-Based
Ayurvedic Formulation (MBAF) named Amar, alongside supportive Ayurvedic compounds and dietary adjust-
ments. Patients underwent pre- and post-treatment evaluations involving interviews, medical records, blood
tests, radiological imaging, and symptom assessments. Notably, pancreatic enzyme use was discontinued prior to
initiating Ayurvedic treatment.
Results: Among 151 patients, 88 completed the year long ATP, resulting in signicant enhancement of their
quality of life. There was a marked 98.7% reduction in emergency hospitalizations and a notable 92.8% decrease
in attack frequency (p <0.0001). Radiological assessments indicated pancreatic health stabilization, while no
adverse effects were reported, highlighting the interventions safety and tolerability.
Conclusion: The study furnishes promising evidence supporting the efcacy and safety of ATP, especially the
MBAF, in managing Hereditary Pancreatitis. The observed decline in attack frequency, absence of adverse effects,
and stabilization of pancreatic health underscore the potential of Ayurvedic medicine. Subsequent research,
including randomized controlled trials, is warranted to substantiate these ndings and elucidate underlying
mechanisms.
1. Introduction
Hereditary Pancreatitis (HP) is dened as a rare gastroenterological
disease characterized by genetic mutations for Pancreatitis or recurrent
acute pancreatitis and/or chronic pancreatitis in at least 2 rst-degree
relatives, or 3 or more second-degree relatives in 2 or more genera-
tions, for which no predisposing factors are identied [1]. Despite
sharing similar symptoms with acute, recurring, and chronic pancrea-
titis, HP is marked by the presence of specic mutated genes in the
patients serum. These mutations, known as "misfolding" mutations,
disrupt the proper folding of digestive enzymes in the endoplasmic
reticulum (ER) [2]. While HP can manifest in children, adolescents, and
adults, it carries a higher morbidity rate compared to other forms of
pancreatitis [3]. Molecular genetic testing techniques vary, ranging
from single-gene tests to multi-gene panels, aiding in its diagnosis [4].
Importantly, the risk of pancreatic cancer is substantially elevated in
individuals with hereditary pancreatitis, reaching up to 55% [5].
First identied by Comfort and Steinberg in 1952, HP was classied
as a form of pancreatitis prone to recurrence and prevalent among
blood-related groups based on Mendelian inheritance patterns [6,7].
Subsequent discoveries in the late 1990s pinpointed mutations in the
PRSS1 gene as the root cause of most HP cases. When a PRSS1 mutation
Peer review under responsibility of Transdisciplinary University, Bangalore.
* Corresponding author. VCPC Research Foundation, Prakash Villa, Beside Rave Cinemas, NH 74, Danpur Area, Rudrapur, 263153, Uttarakhand, India.
E-mail address: balenduprakash@gmail.com (V.B. Prakash).
Contents lists available at ScienceDirect
Journal of Ayurveda and Integrative Medicine
journal homepage: elsevier.com/locate/jaim
https://doi.org/10.1016/j.jaim.2024.100913
Received 24 August 2023; Received in revised form 6 March 2024; Accepted 6 March 2024
Journal of Ayurveda and Integrative Medicine 15 (2024) 100913
2
is inherited, the risk of developing HP is around 80%, with a near 40%
lifetime chance of developing pancreatic cancer, rising to 75% if the
mutation is inherited paternally [8].
Standard treatments for HP involve emergency hospitalization dur-
ing acute episodes, encompassing intravenous uids, pain relief medi-
cations, enzyme supplementation, antibiotics, and a life-long adherence
to a diet low in fats and proteins [9]. However, due to the progressive
nature of the disease, the increasing nancial burden, and the limita-
tions of conventional treatments, patients often explore alternative
therapeutic approaches to alleviate symptoms. While conventional in-
terventions manage the consequences and temporarily relieve pain, they
fall short in halting disease progression [10].
Complementary and alternative medicine systems, including Ayur-
veda, Unani, Siddha, Homoeopathy, and Yoga, are considered inde-
pendent medical approaches alongside conventional medicine [11].
Ayurveda, a traditional Indian system, places great emphasis on diet,
lifestyle, and medicines derived from plant, animal, and mineral sources
[12]. Among its specialized elds, Rasa-Shastra, translating to the "Sci-
ence of Mercury," deals with the therapeutic application of processed
metals and minerals. The safe use of these substances involves the pro-
cess of sublimation with Sulphur to enhance their therapeutic properties
[13].
Remarkably, a North Indian-based Ayurvedic Physician has reported
signicant and enduring benets of Ayurvedic interventions in treating
various forms of Pancreatitis, including Hereditary Pancreatitis. 1750
patients suffering from different variants of Pancreatitis were enrolled at
the clinic for Ayurvedic treatment between January 1997 to July 2023.
Of these, 151 patients were suffering from Hereditary Pancreatitis and
the rst patient of HP was enrolled in October 2001. This study delves
into the substantial advantages of Rasa-Shastra in managing the complex
challenges posed by Hereditary Pancreatitis.
2. Methodology
The Ayurvedic treatment for Pancreatitis started in January 1997
with the enrolment of the rst patient. Earlier the diagnosis was
conrmed on the basis of written ultrasound reports by the treating
gastroenterologists. Later, with more studies stating the role of MRCP in
the diagnosis of Pancreatitis, MRCP became the diagnostic method of
choice from November 2014. Similarly, tests and supplements for
Vitamin D3 and B12 were also introduced around the same time.
Deworming was introduced as a part of the practice for every patient in
2013.
This paper discusses the effects of Ayurvedic treatment protocol in
151 patients of Hereditary Pancreatitis. These patients started treatment
between October 2001 and July 2023. The treatment plan commenced
with an initial three-week residential phase in Uttarakhand, India.
This study encompassed individuals spanning an age range of 362
years, comprising both males and females. Demographic and symptoms
details are provided in Table 1. A thorough examination of the partici-
pants medical history revealed 1351 distinct attacks and 873 emer-
gency hospitalizations. Detailed interviews were conducted to collect
comprehensive information on symptom onset, diagnostic procedures,
hospitalizations, enzyme usage, and personal proles, including dietary
preferences, origin, education, occupation, and family history. All these
details were meticulously documented during the history taking. Prior
to the commencement of the Ayurvedic treatment, participants under-
went a battery of baseline tests, including hemogram, lipid prole, liver
and kidney function tests, diabetes prole, CRP, vitamin levels, serum
amylase/lipase, and Carbohydrate Antigen 19-9 assessment, aimed at
assessing their health status.
The diagnosis of hereditary pancreatitis (HP) was established based
on a combination of family history and the identication of gene mu-
tations. Modern diagnostic techniques, including ultrasound, Magnetic
Resonance Imaging (MRI), Endoscopic Retrograde Chol-
angiopancreatography (ERCP), Computerized Tomography (CT) scans,
and blood tests, were employed to discern variations in pancreatitis
diagnosis. Some patients had undergone stenting and were already un-
dergoing enzyme treatment. Prior to the initiation of Ayurvedic therapy,
a thorough review of previous medical records was conducted, alongside
new Magnetic Resonance Cholangiopancreatography (MRCP)
procedures.
The treatment protocol included the administration of a Metal-Based
Ayurvedic Formulation named Amar at a dosage of 4 mg per kg of body
weight per day, divided into three doses to be taken during meals. This
core treatment was complemented by supportive Ayurvedic formula-
tions such as Prak-20, Kamdudha Ras, Soothsekhar Ras, Narikel Lavana,
Rason Vati, Chitrakadi Vati, which were prescribed based on abdominal
examinations and presenting symptoms (Table 2). All these formulations
are prepared under the authors guidance and an authorized
manufacturing license by his manufacturing unit. A personalized dietary
plan was provided, distributed across three main meals and three snacks
daily. Prohibited items included alcohol, caffeinated and carbonated
beverages, pre-packaged and reheated foods, as well as foods containing
onions, tomatoes, garlic, tamarind, and rened our. Patients were
advised to ensure a minimum of 8 h of nightly sleep and to practice both
mental and physical rest.
Patients who did not undergo deworming in the last six months were
administered an initial dose of 400 mg of Albendazole for two consec-
utive days [14]. Those with low vitamin D3 levels received a weekly
dose of 60,000 IU of cholecalciferol for 16 weeks [15]. The use of all
medicines related to pancreatitis treatment including pancreatic en-
zymes was discontinued prior to the initiation of the Ayurvedic treat-
ment protocol. Diabetic and hypertensive patients were allowed to
continue their respective medications under medical supervision.
Noticeable symptomatic improvement could be seen in rst three
weeks of the initial residential treatment. After the three-week
Table 1
Demography and disease presentation
Patients (n =151)
Age, categories
<12 years 23 (15.23%)
12 years 128 (84.77%)
Age, Mean 24.9 ±12.1 years
Age, Range 362 years
Gender
#
Female 49 (32.45%)
Male 102 (67.55%)
Past history (in years), Range 1 month to 24 years
Symptoms
Abdominal pain 147 (97.35%)
Vomiting 125 (82.78%)
Indigestion 149 (98.67%)
Anorexia 67 (44.37%)
Weight loss 115 (76.15%)
Table 2
Details of formulations prescribed
Formulation Daily Dose Anupan
Amar Capsule 4 mg/kg body weight, divided into
three doses
Protein rich diet/
malai
Prak-20 Capsule 60 mg/kg body weight, divided into
three doses
Water
Rason Vati Tablet 500 mg, 12 tablets thrice after meals Warm water
Chitrakadi Vati
Tablet
250 mg, 12 tablets thrice before
meals
Without water
Kamdudha Ras
Powder
125 mg, twice or thrice 15 min before
meals
Mishri
Sootshekhar Ras
Tablet
250 mg, 12 tablets twice a day on
empty stomach
Water
Narikel Lavan
Powder
1 gm, once-twice a day on empty
stomach
Buttermilk
Hingwastak Churna 250500 mg, thrice a day after meals Warm water
V.B. Prakash et al.
Journal of Ayurveda and Integrative Medicine 15 (2024) 100913
3
residential treatment phase, patients were discharged with a months
supply of prescribed medication. Subsequently, regular communication
between the medical team and patients was maintained through phone
or email, facilitating monthly adjustments of medication regimens based
on symptom progression, weight changes, and laboratory results. This
remote patient management strategy ensured continued effective care,
especially when in-person visits were challenging.
Post-completion of the Ayurvedic Treatment Protocol (ATP), pa-
tients underwent comprehensive evaluations to assess their progress on
physical, pathological, and radiological levels. This data was instru-
mental in determining the efcacy of the treatment, involving a com-
parison of patientspre-treatment conditions with their outcomes post
ATP completion.
2.1. Statistical analysis
Statistical analysis was performed on patients who completed one
year-long Ayurvedic treatment. Data was presented in terms of mean ±
SD, median, percentiles, or range for continuous variables and per-
centage for categorical variables. The pre-and post-frequency and in-
tensity of attacks and emergency hospitalizations analysis were done
using the SAS 9.4 software (Willcoxon two-sample t-test and Mann-
Whitney u test).
3. Observations
Out of the 151 patients enrolled, 31% (n 50) were diagnosed for HP
based on their genetic tests and the diagnosis of the other 69% (n 101)
was based on family history of Pancreatitis.
The age distribution across the patient cohort exhibited a wide de-
mographic range, spanning from 3 to 62 years. Additionally, the dura-
tion of their respective illness histories demonstrated considerable
heterogeneity, encompassing recorded durations ranging from 1 month
to 25 years.
The demographics of enrolled patients provide valuable insights into
the prevalence of HP with notable concentrations in Maharashtra (18
cases), Uttar Pradesh (15 cases), and Telangana (13 cases). Interestingly,
contrary to the popular belief, the incidence of HP was more seen among
individuals who did not consume alcohol (79.5% non alcoholics) or
tobacco (88% non tobacco users). Among the patients who consumed
alcohol, 61.3% were occasional drinkers (<6 times in a year) and 38.7%
were regular users (>500 ml per week). Also, 54% patients were vege-
tarians. As per their reports, three patients had gall stones and six had
sludge in gall bladder, while, six patients had undergone cholecystec-
tomy before opting for Ayurvedic treatment. No known etiology could
be established in the other patients.
Among the 151 patients, 88 individuals with a mean age of 23.11 ±
11.63 years completed the Ayurvedic Treatment Protocol (ATP), leading
to a signicant improvement in their quality of life, marked by a life free
from pain and other symptoms. Meanwhile, 41 patients opted to dis-
continue treatment for various reasons, six patients enrolled for the ATP
but did not commence treatment and one patient died due to Dengue
fever during the treatment period. 15 patients continue to receive the
treatment. The positive impact of the yearlong Ayurvedic treatment is
evident in the subset of patients who completed it (n =88), with the
longest disease-free survival reaching 22 years for the rst patient
enrolled in 2001. While, the last patient in this series was enrolled in
July 2023 and is under treatment with no symptoms for two months. The
statistically signicant reduction of 98.7% in emergency hospital ad-
missions and a notable 92.8% reduction in attack frequency (p <
0.0001), highlight the efcacy of the treatment. Flow chart of the patient
disposition has been depicted in Fig. 1.
This outcome was successfully attained even after the cessation of
pancreatic enzymes upon initiating ATP. Notably, no patients docu-
mented any instances of adverse effects, thus suggesting a high degree of
tolerability for the Ayurvedic treatment. Moreover, on conducting a
comprehensive comparative analysis of radiological images acquired
before and after the treatment, no indications of disease progression
have been identied among these patients.
4. Discussion
Hereditary Pancreatitis, characterized by genetic mutations, shares
several overlapping symptoms with other forms of pancreatitis [16].
This study delves into the efcacy of a yearlong Ayurvedic treatment
protocol in managing Hereditary Pancreatitis (HP), a condition char-
acterized by recurrent and chronic inammation of the pancreas, often
associated with specic gene mutations.
Ayurveda, originating from India, is a traditional medical system
that adopts a holistic approach to health and well-being. It employs a
range of natural therapies, including dietary adjustments, herbal rem-
edies, and lifestyle modications, to restore equilibrium in the body and
support normal digestive functions and overall health.
The present studys methodology involves the treatment of a diverse
patient group consisting of 151 individuals of varying ages and both
genders. The treatment protocol used a Metal-Based Ayurvedic Formu-
lation (MBAF) named Amar, supplemented by supportive Ayurvedic
formulations and dietary modications.
Amar, derived from Rasa-Shastra, a specialized branch of Ayurveda
focusing on Mercury, metals, and minerals, is prepared through a
meticulous process involving Copper, Mercury, and Sulphur. Lemon
juice and aqueous extracts of Luffa echinata and Clitoria ternatea are used
in its processing. We can say that it is an amalgamation of two principles.
Copper has been mentioned as Shoth Nashak but toxic in nature.
Mercury is described to process copper and sulphur (Gandhak) is
described to eliminate the toxic nature of Mercury by following the
concept of Gandhak Jarana. Repeated Jarana leads to Jeerna stage of
mercury which possesses Rog nashak properties. This is very briey
quoted but not explained in Rasa Tarangini and other texts of rasa
shastra. Late Vaidya Chandra Prakash, father of the author, put both
concepts together in early seventies and could evolve the formula of
AMAR. This formulation, requiring a three-year processing duration,
showcases remarkable potential in yielding therapeutic benets in
pancreatic disorders [17].
Results of the study present promising prospects, with 88 patients
successfully completing the yearlong Ayurvedic Treatment Protocol
(ATP) and experiencing noteworthy enhancement in their quality of life.
These individuals reported being free from pain and resuming normal
activities.
Geographical distribution analysis highlights a higher prevalence of
HP in specic Indian states, notably Maharashtra and Uttar Pradesh.
This observation might imply genetic predispositions or environmental
Fig. 1. Flow chart of enrolled patients.
V.B. Prakash et al.
Journal of Ayurveda and Integrative Medicine 15 (2024) 100913
4
factors inuencing disease incidence. The study also underscores
lifestyle-related aspects, with a majority of patients being non-alcoholics
and non-tobacco users.
A key nding of the study lies in the substantial reduction of attack
frequency and emergency hospitalizations following Ayurvedic treat-
ment. Remarkably, these improvements persisted even after dis-
continuing pancreatic enzyme use, suggesting the Ayurvedic approachs
potential to impact underlying disease mechanisms. The Ayurvedic
intervention exhibited a favorable safety prole, devoid of reported
adverse effects or complications. Radiological evaluations pre- and post-
treatment displayed no signs of disease progression in patients who
completed the ATP, indicating a stabilization of pancreatic health.
Additionally, the studys extended-term results, depicted through the
symptom-free survival curve, illustrate that HP patients could experi-
ence disease-free intervals of up to 22 years. This suggests the possibility
of utilizing Ayurvedic medicine to extend symptom-free periods for in-
dividuals with Hereditary Pancreatitis.
5. Conclusion
In summary, this study underscores the potential merits of Ayurvedic
treatment, particularly the Metal-Based Ayurvedic Formulation (MBAF),
in the management of Hereditary Pancreatitis. The substantial reduction
in the frequency of pancreatitis attacks, coupled with the absence of
adverse effects and the lack of disease progression among all treated
patients, signies that the Ayurvedic protocol holds promise as an
adjunctive or alternative therapeutic avenue for individuals dealing
with HP. However, to substantiate its efcacy and unravel its mecha-
nisms of action, further exploration through randomized controlled
trials is imperative. This study offers valuable insights into the man-
agement of Hereditary Pancreatitis, shedding light on the viability of
Ayurvedic interventions in addressing intricate genetic disorders.
Details of Ayurveda treatment
Ayurvedic Treatment
Diet (Aahar) 16002200 calories daily balanced diet divided into three
meals and three snacks. Each patient is prescribed protein
following age and weight guidelines.
Lifestyle (Vihaar) Eight hours of sleep at night. Avoiding physical and mental
exertion.
Medicines
(Aushadh)
AMAR 4 mg/kg body weight/day, divided into three doses
with each meal. Other medicines are given based on patients
symptoms.
Making of AMAR
Copper (Tamra), Mercury (Parad) and Sulphur (Gandhak) are the main ingredients of
AMAR. The process begins with shodhan (purication)of the raw materials. Shodhit
Copper and Mercury and ground into ne powder form. This powder is then ground
with Shodhit Gandhak by adding liquid extract prepared using lemon juice, Aprajita
and Devdali until the material attains particle size of <5
μ
at 40X (Checked using
particle size analyser). The paste is then made into small pellets and sun dried. After
drying, the pellets are subjected to continuous cooking on re in sealed glass coated
clay pots (nalika damru yantra) at 360400 C.. After cooling, it is again wet ground
agin with added Sulphur using lemon juice. The compound is then again subjected
to gandhak jarana. Gradually same amount of Sulphur takes more time to evaporate
and Sulphur nearly two times the quantity of Mercury remains stable on re inspite
of long cooking hours, which has increased from 12 to 120 hours constant cooking.
This is described at dwiguna gandhak jeerna parad in Ayurvedic texts. The cycle is
repeated 100 times with the re exposure gradually increasing in each cycle for
about 3 years. Non destructive analysis using XRD has depicted that 100 times
gandhak jarit formulation does not possess any trace of free metals.
Liquid used in grinding is made of Lemon juice, Aprajita (Clitoria ternatea), Devdali
(Luffa echinate). 16 L lemon juice with 1 kg Aprajita and Devdali each is prepared.
1.89 L of this juice is usually consumed during each grinding. The juice
consumption gradually increases in each cycle.
Sources of Funding
This was an inhouse funded project. The patients paid for their
treatment.
Author contribution
VBP: Conceptualization, study design, validation, resources, data
curation, writing, supervision and project administration. SP: Concep-
tualization, study design, investigation, review and editing, supervision,
project administration. NN: Formal analysis and writing. STS: Formal
anlysis and review and editing
Data Statement
All data mentioned in the manuscript is available with the authors
and can be presented on request.
Declaration on use of generative AI in scientic writing
None
Conict of interest
Authors declare no conicts of competing interest.
Acknowledgement
Authors are grateful to the patients and their families for agreeing to
share their medical records.
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The word Rasashaastra literally means the “Science of Mercury”. It is a specialized branch of Ayurveda dealing mainly with materials which are known as ‘Rasa dravyaas’. The products dealt under this discipline are an important component of Ayurvedic therapeutics. Considering the importance of this discipline in Ayurvedic therapeutics and the fact that there is dearth of comprehensive review on the subject an attempt has been made in this review to provide a brief but all encompassing coverage of different aspects related to it. The subjects covered in the review are : historical background of the evolvement of Rasashaastra as a specialized branch during different time periods; different aspects of classification ‘Rasa dravyaas’; processing of metal and mineral products with a note on the methods used during different time periods; information about methods of pre and post preparation procedures for different kinds of ‘Rasa dravyaas’; importance of mercury in Ayurveda, its processing methods and different preparations along with therapeutic indications. In addition attempt has been made to provide basic information on the metal and mineral based preparations mentioned in Ayurvedic Formulary of India; recent development in the field of Rasashaastra and future requirements for the proper development of the discipline. The main focus is to familiarize the readers, from non-ayurvedic background, on different aspects of this specialized discipline. Key words: Rasashaastra, Rasa dravyaas, Traditional systems of medicine ,Mineral and metal based formulations Ayurvedic formulations, Iatrochemistry of Ayurveda doi: 10.4314/ajtcam.v8i5S.1