Relevance of metal based Ayurvedic formulations in the management of recurrent acute/ chronic pancreatitis

Abstract

Recurrent Acute Pancreatitis/ Chronic Pancreatitis (RAP/ CP) is generally marked by sudden onset of symptoms like severe abdominal pain, vomiting and weight loss that needs emergency hospitalization. Owing to irreversible and progressive nature of the disease and limitations of conventional treatment, many patients look for an alternative solution. Here, we report data of 250 well diagnosed cases of acute recurring/ chronic pancreatitis, enrolled in between January 1997 to August 2016, in our Ayurvedic clinical practice in Northern part of India. Ayurveda is well recognized as an independent medical system parallel to conventional medicines in India and a subject is free to opt for any system of medicine for the prevention and treatment of any ailment. The subjects were treated with a complex herbo-mineral formulation based on the principles of Rasa Shastra in Ayurveda that deals with the therapeutics of processed metals in the prevention and treatment of diseases. They were also prescribed a regulated balanced diet and lifestyle. Significant improvement has been noted in subjects who have completed the treatment.

Full text

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TANG / www.e-tang.org
2017 / Volume 7 / Issue 2 / e9
Original Article
Relevance of metal based Ayurvedic formulations in the management of
recurrent acute/ chronic pancreatitis
Vaidya Balendu Prakash*, Vaidya Shikha Prakash, Shakshi Sharma, Sneha Tiwari
Padaav Speciality Ayurvedic Treatment Centre, Turner Road, Clement Town, Dehradun, India
ABSTRACT
Recurrent Acute Pancreatitis/ Chronic Pancreatitis (RAP/ CP) is generally marked by sudden onset of
symptoms like severe abdominal pain, vomiting and weight loss that needs emergency hospitalization.
Owing to irreversible and progressive nature of the disease and limitations of conventional treatment,
many patients look for an alternative solution. Here, we report data of 250 well diagnosed cases of acute
recurring/ chronic pancreatitis, enrolled in between January 1997 to August 2016, in our Ayurvedic
clinical practice in Northern part of India. Ayurveda is well recognized as an independent medical system
parallel to conventional medicines in India and a subject is free to opt for any system of medicine for the
prevention and treatment of any ailment. The subjects were treated with a complex herbo-mineral
formulation based on the principles of Rasa Shastra in Ayurveda that deals with the therapeutics of
processed metals in the prevention and treatment of diseases. They were also prescribed a regulated
balanced diet and lifestyle. Significant improvement has been noted in subjects who have completed the
treatment.
Keywords Rasa Shastra, Ayurveda, pancreatitis, chronic, recurrent acute
INTRODUCTION
Chronic pancreatitis (CP) is a progressive inflammatory disease
of the pancreas characterized by irreversible morphological
changes typically causing pain and/or permanent loss of
function (Sarner and Cotton, 1984; Taber, 1997). The global
incidence of Pancreatitis ranges from 2-14/100,000 population
but Southern India reports highest incidences ranging from
114-200/100,000 population. The report indicates that India has
highest incidences of Tropical Chronic Pancreatitis (TCP),
where alcohol is not the major cause (Geeverghese et al., 1969;
Garg and Tandon, 2004). Rather it is attributed to protein
malnutrition, mineral deficiency, dietary toxins and
environmental agents. There are emerging evidences about the
role of genetics as well (Balakrishnan et al., 2005).
RAP/CP has no known cure. The acute attacks are largely
managed by emergency hospitalisation and treated with
analgesics, antibiotics and IV fluids. Enzyme replacement
therapy and vitamin supplements are widely used for long
terms as prophylactic therapy. Progressive nature of the disease
coupled with rising medical cost and limitations of
conventional treatment compel many patients to look for
alternatives to bring some relief to their lives. India is the only
country where different systems like Ayurveda, Unani, Siddha,
Homeopathy and Yoga are officially recognised as independent
medical systems, along with conventional medicine termed as
allopath. The prevailing laws permit a registered medical
practitioner of Ayurveda and Unani to prepare his own
medicines and to use those directly in respective clinical
practice for any indication with the consent of the patient
(Government of India ministry of health and family welfare,
2003).
In mid 70s, a traditional Ayurvedic physician incidentally
observed miraculous effect of a Metal Based Ayurvedic
Formulation (MBAF; Herbo mineral formulation used for the
treatment of pancreatitis (Patent filed vide PCT application
no.3373/DEL/2014), in a terminally ill patient of pancreatic
cancer (Pal, 2014). Subsequently, MBAF showed empirical
success in patients suffering from recurring pancreatitis. The
practice was passed on to the next generation and patients
continue to get the benefit of this treatment. The ongoing
clinical practice was subjected to documentation from January
1997.In this study, we report the effect of Ayurvedic Treatment
Protocol, comprised of herbo mineral formulations, customized
diet and lifestyle in 250 patients of RAP/ CP who were enrolled
till August 2016.
Literature Review
Inflammation is the stereotyped non specific immune response
that occurs in reaction to any harmful stimuli, pathogenic
organism, foreign body, physical trauma, ionizing radiation,
electrical energy, or extremes of temperature (Taber, 1997).
Inflammations can be broadly classified into Acute and Chronic.
While acute inflammations are attributed to infection, injury or
trauma, chronic ones are known to be caused due to long
lasting injury, infection or might be idiopathic. Chronic
inflammations become a constant low-level physiological
response, which the body is no longer able to turn off and it
starts damaging healthy tissues. Most of the times, these
inflammations are irreversible and progressive in nature and
might be fatal.
In recent years, there has been an upsurge in incidences of
idiopathic, non communicable and non specific Chronic
*Correspondence: Vaidya Balendu Prakash
E-mail: balenduprakash@gmail.com
Received February 18, 2017; Accepted May 26, 2017; Published May
31, 2017
doi: http://dx.doi.org/10.5667/tang.2017.0007
© 2017 by Association of Humanitas Medicine
This is an open access article under the CC BY-NC license.
(http://creativecommons.org/licenses/by-nc/3.0/)

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Inflammatory Disorders (CIDs). These cover a number of
conditions from several autoimmune and metabolic disorders to
even transplant rejection. The number of people suffering from
CIDs has been increasing over the last three decades. A study
documented that CIDs are the largest cause of death in the
world and caused about 29 million deaths in 2002. About 171
million people in the United States are estimated to be affected
by CIDs by 2030 (Cicchitti et al., 2015). However, not much
data on this effect is available from India.
Inflammations can be treated by addressing the underlying
aetiology. Currently available treatments for CIDs involve
prolonged use of anti-inflammatory drugs, including non
steroidal anti-inflammatory drugs, corticosteroids and immune
selective anti-inflammatory derivatives, which have
considerable side effects (Bosma-den Boer et al., 2012). A
recent review highlighted that current medications used to treat
CIDs suppress the symptoms but prevent the complete
resolution of the disease, leading to a persistent low grade
inflammation. Long lasting use of anti-inflammatory
medications is also known to delay full recovery (Bosma-den
Boer et al., 2012).
Pancreatitis is one among such inflammatory disorders,
which refers to inflammation of the pancreas and is primarily
characterised by abdominal pain, nausea, vomiting and
indigestion (Kedia et al., 2013). Repeated episodes of
abdominal pain, other symptoms and elevated serum Amylase/
Lipase levels without morphological changes in the pancreas is
termed as RAP while, signs and symptoms associated with
morphological changes in the pancreas is called Chronic
Pancreatitis (Kedia et al., 2013; Sawant and Mishra, 2005). The
average onset of the disease is 24 years and the disease affects
more male population than female population (Sawant and
Mishra, 2005). RAP/CP brings gradual fibrotic changes in the
pancreas resulting in loss of exocrine and endocrine functions,
leading to diabetes mellitus, steatorrhoea and unexplained
weight loss (Bharathi, 2015). More than 70% of the patients
develop diabetes mellitus (up to 90% in cases of chronic
calcific pancreatitis) and up to 40% patients develop pancreatic
cancer in their lifetimes (Malka et al., 2000; Howes and
Neoptolemos, 2002). RAP/CP is progressive and fatal in nature
and the prognosis remains uncertain with a 10 year survival of
about 70% and a 20 year survival of 45% (Sawant and Mishra,
2005). A recent study showed that even a single attack of acute
pancreatitis may harbour underlying chronic pancreatitis
(Turner, 2013).
The underlying cause for RAP/CP has not yet been
established although it is considered to be a disease of
alcoholics, smokers, people with high fat intake and high stress
factor. The most accepted etiology for chronic pancreatitis
includes Toxic, Idiopathic, Genetic factors, Auto-immune
response, Recurrent acute pancreatitis and Obstructive factors
(TIGAR-O) (Etemad and Whitcomb, 2001).
RAP/CP is a global disease and in recent years, there has
been an upsurge in its incidences. It is estimated that the annual
global market of pancreatic enzymes will touch INR 11,000 Cr
by 2023 (US$ 1,588.8 million) as compared to INR 5000 Cr in
2014 (US$ 707.0 million) (Transparency Market Research,
2016). It seems that India, especially its Southern states, has the
highest incidences of pancreatitis in the world and is termed as
Tropical Chronic Pancreatitis (TCP). Most of the patients
suffering from TCP are non alcoholic. Protein malabsorption
and mineral deficiency are considered to be its major cause
(Geeverghese et al., 1969; Rajesh and Balakrishnan, 2012).
Another prevalent form of pancreatitis in India is idiopathic
pancreatitis (ICP) that accounts for 40% - 60% CP in India and
10% - 30% in the western countries (Rajesh and Balakrishnan,
2012).
There is no direct or indirect reference of Pancreatitis in
classical Ayurvedic literature except a term called ‘UdarShool’
(abdominal pain).
Methodology
The subjects with confirm diagnosis of RAP/CP were selected
for Ayurvedic treatment. Such subjects were diagnosed by
leading gastroenterologists at various hospitals of repute across
India. Diagnosis of RAP/CP was established using clinical,
pathological and radiological investigations including USG
(Ultra Sonography), EUS (Endoscopic Ultrasound), CT
(Computer Tomography), MRI (Magnetic Resonance Imaging),
MRCP and ERCP (Endoscopic retrograde
cholangiopancreatography) (Figure 1).
The patients and their families were briefed about unknown
chemistry and pharmacology of MBAF, duration and cost of
treatment prior to commencement of Ayurvedic treatment. Each
subject was interviewed for detailed medical history, including
number of emergency hospitalisations, follow up visits and
expenditure occurred so far. Their demography, dietary habits,
lifestyle and family history were also recorded. Copies of
relevant medical records including diagnostics and previous
medical treatment were collected from each subject. The
subjects were evaluated for hemogram, liver function, kidney
function, Vitamin D3 and B12. The Ultrasound/ MRCP was
also repeated if the last report of the subject was more than
three months old.
Patients reported with anorexia, mild to moderate abdominal
pain, weight loss, weakness and phobia of the disease. All
patients were given Albendazole (deworming medication) on
the first day of AYT. They were asked to stop tea, coffee,
Table 1. Financial burden of Pancreatitis on patients
Emergency expenses
(INR)
Direct expenses (INR)
Indirect expenses
(INR)
Cost of hospitalization
Follow ups,
investigations,
medicines, consultation
Loss of manpower, cost
of travelling, boarding
and lodging during
treatment for families
3,97,61,000
2,86,44,750
3,04,35,500
Total
9,88,41,250
n = 132.
Table 2. Various parameters before and after treatment
Parameters
Before AYT
After AYT
P value
Number of Attacks*
2 (0 to 25)
0 (0 to 5)
< 0.0001
Number of
Hospitalizations*
1 (0 to 20)
0 (0 to 0)
< 0.0001
Intake of
enzymes, %#
54 (50.9)
0 (0.0)
< 0.0001
Mean Body weight¥
57.59 ± 12.65
59.66 ± 12.32
< 0.0001
(n = 106); *indicates median (range) and compared using Wilcoxon
signed rank test for paired observations; #indicates n (%) and compared
using Mc Nemar’s test; ¥ indicates mean ± SD and compared using
paired t test.

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aerated drinks, reheated food, packaged food items and drinks,
refined flour, onion, tomato and garlic. They were subjected to
an Ayurvedic regime of treatment, diet, lifestyle and medicines
(Aahar, Vihar and Aushadh). They were prescribed Narikel
lavan 1 gm BD, Prak 20 (A proprietary Ayurvedic medicine
prepared by Bharat Bhaishajyashala Pvt Ltd. Mfg License No.
A-1969/91 by Dept. of AYUSH, Ministry of Health and Family
Welfare, Govt. Of Uttarakhand.) 1 gm BD, MBAF 125 mg
during meals and Rason vati 500 mg with hot water after meals
with 1200-1600 calorie diet, divided into three meals and three
snacks, along with eight hours sleep and moderate physical and
mental rest (Vaidya et al., 2010). The diet also included dairy
products, fat and protein. Subjects who were deficient in
Vitamin D3 were given a weekly dose of 60,000 IU
Cholecalciferol with 100 gm milk cream for sixteen weeks and
those deficient in Vitamin B12 were given daily supplement of
Mecobalamin 1500 mcg with breakfast. The first three weeks
residential treatment was given under close supervision of the
Ayurvedic physician in his clinic. The service of a conventional
doctor was taken to control high blood sugar among diabetic
patients. After the initial residential treatment, subjects were
prescribed monthly Ayurvedic formulations and kept under
daily follow ups via mails or telephone. The treatment was
repeated every month for duration of one year. On completion
of one year, patients were called for follow up examination and
the treatment was stopped. These patients continue to remain in
contact.
RESULTS
A total number of 250 patients of RAP/CP volunteered for
Ayurvedic treatment from January 1997 to August 2016. Nearly
two third subjects were males and one fourth were females with
a mean age of 31 ± 12.2 years. The demography depicts 62%
vegetarians, 76.8% non alcoholics, 85.6% non tobacco users
and 94.8% subjects with no family history (Figure 2). The
subjects had a history of 45.3 ± 49.6 months with 1779 attacks
and 1030 hospitalizations and had been treated conservatively
under expert advice using analgesics, antibiotics, IV fluids and
enzyme replacement therapy. 50.9% patients had been put on
lifelong pancreatic enzymes ranging from 20,000 to 75,000 IU
per day. Some of the patients had also undergone surgical
intervention before starting ayurvedic treatment.
A random survey conducted on 132 patients revealed that
these subjects had spent a total amount of INR Nine crores
eighty eight lacs forty one thousand two hundred and fifty
(9,88,41,250/-) prior to Ayurvedic treatment on emergency
hospitalizations, follow ups and indirect expenditure (Table 1).
Subjects showed improvement in overall appetite, energy,
pain, stability in sugar levels and general well being within the
first three weeks of commencement of the treatment. There is
significant reduction in frequency, intensity of pain and need of
hospitalization with significant gain in body weight (Table 2).
No grade II toxicity has been reported in the treated patients.
They are leading a symptom free life (Figure 4).
DISCUSSION
RAP/CP is an inflammatory state of pancreas. It is irreversible
and progressive in nature and leads to gradual morbidity.
Besides its invariable characteristics, it also brings substantial
physical, emotional and financial burden to its patients and
their families. Consumption of alcohol is considered to be the
main causative factor of RAP/CP. However, Indian
subcontinent has more cases of TCP. In the present
observational study, subjects opted for metal based Ayurvedic
treatment in desperate state of mind after hearing anecdotal
success stories. The incidental effect of MBAFs continue to
bring long term relief to RAP/CP patients though, no direct or
indirect reference in available about this disease in classical
texts. MBAF are prepared using the principles of Rasa shastra,
Fig. 1. Methods of diagnosis of the subjects.
Table 3. Results of random analysis of three batches of MBAF (Source:
IISc, Bangalore)
MBAF A
MBAF B
MBAF C
CuFeS2
CuFeS2
CaSO4
CuFe2O4
CuFe2O4
CuS
KCu2(OH)(SO4)2.H2O
Cu2SO4
SiO2
Cu2SO4
KCa2(Si7Al)O17(OH)2
K2Mg(SO4)2.6H2O
KFe3(SO4)2(OH)6
KCu2(OH)(SO4)2.H2O
KFe3(SO4)2(OH)6
KCa2(Si7Al)O17(OH)2
KFe3(SO4)2(OH)6
KFe(SO4)2
SiO2
CuS
HgS
CuS
K2Cu(SO4)2.6H2O
FeSO4(H2O)7
K2(Cu(H2O)6).(SO4)2
SiO2
Ca(Mg.67Fe.33)(CO3)2
K2MgSiO4
Cu4SO4(OH)6
K2Cu(SO4)2.6H2O
Cu4SO4(OH)6
MgFe2O4
K2SO4

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a specialty of Ayurveda. In Ayurvedic texts, Mercury has been
referred to as Rasa due to its ability to imbibe other metals
within itself (Virupaksha Gupta et al., 2011). Rasa Shastra is
the sciencewhich deals with the therapeutics of Mercury, Gold,
Silver, Iron, Tin, Lead and Zinc etc. termed as dhatu (Savrikar
and Ravishankar, 2011).These metals undergo tedious
processing with herbs on fire and convert into safe and
therapeutic form. Dhatu vigyan means science of metals.
‘Dharanat dhatavah’ means that the thing which bears is
known as dhatu. The term dhatuis used for ‘Rasa Rakta Maans
Medh Asthi Majja Shukra’ (body tissues) and for Gold, Silver,
Copper, Iron, Tin, Lead and Zinc. Masters of Rsashastra have
ascribed close linkage between both types of dhatu (Vaidya
Chandra Prakash as dictated by Guru Maharaj. Dhatu Vigyan:
Unpublished handwritten booklet). Dietary, environmental,
ecological or lifestyle related factors may bring imbalance
among these dhatus in body tissues and cause pathogenesis of
disease in the human body.
The main MBA Fused for the treatment of RAP/ CP is
prepared using Mercury, Sulphur and Copper as raw material.
These undergo numerous processing for years, mostly repeated
grinding in iron vessels (till > 88% particles attain size < 5µm)
and heating in clay pots (365 - 400 ºC for 12 - 80 hours). The
random analysis of three batches of MBAF carried using XRD
technique demonstrates that the subjected formulation is a
complex of minerals and is devoid of any free metal (Table 3).
The study of first 250 patients clearly demonstrates that all
subjects had RAP/CP. Similarly, observations indicate that
MBAF brought significant relief in reducing number of
hospitalisations, intensity and frequency of attacks. It also
improved physical and psychological state with significant
reduction in cost. Subjects also reported weight gain and
improvement in quality of life.
The main MBA Fused for the treatment of RAP/ CP is
prepared using Mercury, Sulphur and Copper as raw material.
These undergo numerous processing for years, mostly repeated
grinding in iron vessels (till > 88% particles attain size < 5µm)
and heating in clay pots (365 - 400 ºC for 12 - 80 hours). The
random analysis of three batches of MBAF carried using XRD
technique demonstrates that the subjected formulation is a
complex of minerals and is devoid of any free metal (Table 3).
The study of first 250 patients clearly demonstrates that all
subjects had RAP/CP. Similarly, observations indicate that
MBAF brought significant relief in reducing number of
hospitalisations, intensity and frequency of attacks. It also
improved physical and psychological state with significant
reduction in cost. Subjects also reported weight gain and
improvement in quality of life.
Dairy products and rich protein diet is contradictory in the
treatment of pancreatitis. However, patients were given a diet
rich in protein and dairy products after starting Ayurvedic
treatment. The observed effect of Ayurvedic treatment on
pancreatitis patients raises many questions regarding its
intrigue chemistry, dose schedule, mode of action and duration.
Heavy metals are known to be toxic but in this study, no
grade II toxicity has been reported in any subject (Singh et al.,
2011). Ayurveda is an ancient system of medicine of India
which is not understood for its therapeutic efficacy. Its
principles were laid thousands of years ago using language,
parameters and protocols of that era. In recent years,
complementary and alternate medicines have gained wide
popularity but mostly on wellness part. Prima facie evidences
do suggest that Ayurveda might have therapeutic effects as well.
Therapeutic use of metals is a virgin area of science and not
much work has been done on this specialized branch of
Ayurveda. We suggest that scientific fraternity take note of
these preliminary findings and will develop a pragmatic
approach to explore the therapeutics of metal based Ayurvedic
treatment for the prevention and treatment of both types of
Pancreatitis. This will require a combined programme where
traditional wisdom should be incorporated with modern
scientific tools to develop a reproducible, safe and effective
treatment protocol.
CONCLUSION
The preliminary clinical data indicates that MBAF derived
from Rasa shastra in Ayurveda might be a potential
prophylactic treatment for RAP/ CP.
ACKNOWLEDGEMENTS
Fig. 2. Demography, dietary habit and family history of the subjects.

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We duly acknowledge all patients and their families for
participation in the programme.
CONFLICT OF INTEREST
The author declares that there is no conflict of interest.
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