Ayurvedic treatment protocol in the management of pancreatitis: A nonrandomized observational study

Abstract

Recurrent Acute/Chronic Pancreatitis (RA/CP) is a progressively debilitating disease with rising incidences in recent years. The limitations of conventional treatment, along with the psychological fear and financial burden associated with it, compel the patients to explore alternative options. In India, where traditional medicines are recognized as treatment options, a North India-based ayurvedic clinic has been treating RA/CP patients using an ayurvedic Herbo-Mineral Formulation (HMF) with a balanced diet and regulated lifestyle. The HMF is prepared using processed mercury, copper, and sulfur following the principles of Rasashastra. The HMF has demonstrated pancreatitis preventive properties in rat models and passed acute, subacute, and chronic toxicity assessments. This retrospective study enrolled 1750 well-diagnosed cases of RA/CP from January 1997 to July 2023. About 67% of the enrolled patients were nonalcoholics, 81% were nontobacco users, and 93% had no family history of the disease. The age group of 19–45 years represented the highest proportion of patients, with a male predominance (5:1). Nine hundred and sixteen patients with RA/CP completed 1-year ayurvedic intervention using HMF, without pancreatic enzymes. The ayurvedic treatment resulted in a significant 93% reduction in the frequency of pancreatitis attacks and a 97% decrease in emergency hospitalizations. The HMF has shown no adverse effects or toxicity in the treated patients. About 1.7% of patients experienced mortality during the treatment or follow-up period due to various reasons. The ayurvedic treatment protocol demonstrated sustainable effects, with the longest remission exceeding 26 years, and has brought a significant reduction in frequency and intensity of RA/CP attacks with an overall improvement in quality of life, warranting further randomized clinical trials to establish strong proof of efficacy.

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© 2024 International Journal of Ayurveda Research | Published by Wolters Kluwer - Medknow 205
Ayurvedic treatment protocol in
the management of pancreatitis:
A nonrandomized observational study
Balendu Prakash, Shikha Prakash1, Sneha Tiwari Sati, Neha Negi1
ABSTRACT:
Recurrent Acute/Chronic Pancreatitis (RA/CP) is a progressively debilitating disease with rising
incidences in recent years. The limitations of conventional treatment, along with the psychological
fear and nancial burden associated with it, compel the patients to explore alternative options. In
India, where traditional medicines are recognized as treatment options, a North India‑based ayurvedic
clinic has been treating RA/CP patients using an ayurvedic Herbo‑Mineral Formulation (HMF) with a
balanced diet and regulated lifestyle. The HMF is prepared using processed mercury, copper, and
sulfur following the principles of Rasashastra. The HMF has demonstrated pancreatitis preventive
properties in rat models and passed acute, subacute, and chronic toxicity assessments. This
retrospective study enrolled 1750 well‑diagnosed cases of RA/CP from January 1997 to July 2023.
About 67% of the enrolled patients were nonalcoholics, 81% were nontobacco users, and 93% had
no family history of the disease. The age group of 19–45 years represented the highest proportion of
patients, with a male predominance (5:1). Nine hundred and sixteen patients with RA/CP completed
1‑year ayurvedic intervention using HMF, without pancreatic enzymes. The ayurvedic treatment
resulted in a signicant 93% reduction in the frequency of pancreatitis attacks and a 97% decrease
in emergency hospitalizations. The HMF has shown no adverse effects or toxicity in the treated
patients. About 1.7% of patients experienced mortality during the treatment or follow‑up period due to
various reasons. The ayurvedic treatment protocol demonstrated sustainable effects, with the longest
remission exceeding 26 years, and has brought a signicant reduction in frequency and intensity of
RA/CP attacks with an overall improvement in quality of life, warranting further randomized clinical
trials to establish strong proof of efcacy.
Keywords:
Carbohydrate antigen 19‑9 levels, Chronic pancreatitis, Recurrent acute pancreatitis
INTRODUCTION
Pancreatitisisaninammatorydisorderof
the pancreas and is broadly categorized
into Acute Pancreatitis (AP) and Chronic
Pancreatitis (CP).[1] The disease is majorly
characterized by uncontrolled pain in the
upper abdomen radiating to the back,
nausea, vomiting, loose stool, and bloating.
Certain cases never experience bouts
of pain but report substantial weight
loss, uncontrolled blood sugar, and
steatorrhea.[2]
APreferstoshort‑terminammationofthe
pancreas with elevated amylase and lipase
levels in blood.[3] Marked visible structural
changes in the pancreas in imaging tests and
low fecal elastase levels in stool are diagnostic
features of CP. These might include the
formation of pseudocysts, calcification,
formation of stones, and dilatation of
pancreatic ducts.[2] Pancreatitis may also
be associated with various complications
including necrosis, abscess, hemorrhage,
obstruction, and multiple organ failure.[4]
Pancreatitis has no established cause but
various factors such as gallstones, heavy
Address for
correspondence:
Vaidya Balendu Prakash,
Prakash Villa, Beside
Rave Cinemas,
NH 74, Rudrapur,
Uttarakhand - 263 153, India.
E-mail: balenduprakash@
gmail.com
Received: 17-08-2023
Revised: 12-08-2024
Accepted: 13-08-2024
Published: 30-09-2024
VCPC Research
Foundation, 1Padaav
Speciality Ayurvedic
Treatment Centre,
Rudrapur, Uttarakhand,
India
Short Communication
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DOI:
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How to cite this article: Prakash B, Prakash S,
Sati ST, Negi N. Ayurvedic treatment protocol in
the management of pancreatitis: A nonrandomized
observational study. Int J Ayurveda Res
2024;5:205-9.
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206 International Journal of Ayurveda Research | Volume 5 | Issue 3 | July-September 2024
alcohol use, genetic disorders of the pancreas, certain
medicines, viral or parasitic infections, abdominal
injury, and pancreatic divisum have been indicated to
contribute to the acute condition.[5] Causes of CP are
classiedasToxins, Idiopathic,Genetic,Autoimmune,
Recurrent acute attacks, and Obstruction of pancreatic
ducts (TIGAR‑O).[6] Indian scenario is somewhat
different, where the most prevalent form, Tropical
Chronic Pancreatitis (TCP) has been attributed to protein
malnutritionandmineraldeciency.[7]
Both AP and CP are relapsing‑remitting and progressive
in nature and may turn fatal at any time during the
course of the disease. Acute exacerbations require
emergency hospitalizations and most patients have to
become dependent on lifelong enzyme supplements.
A study carried out in Australia on about 153 subjects
indicates that even a single episode of AP may turn
into CP in the lifetime of the patients.[8] CP may further
progress to pancreatic cancer in up to 55% of cases and
uncontrolled diabetes in 70%–90% of cases.[9,10] AP may
cause 4.8%–13.5% mortality during hospitalization. Out
of these, 50% are attributed to multi‑organ failures.[11] CP
leads to 17%, 30%, and 55% deaths in 5, 10, and 20 years,
respectively.[12] Pancreatitis poses a substantial physical,
emotional,andnancialburdentovictimsandtheir
families.
The incidences of pancreatitis are on the rise and have
globally increased by more than two folds from the year
1990 to 2017.[13] While conventional treatment is useful
in handling emergency situations and prolonging life
span, its limitations along with the uncertain nature of
the disease and its progression, lead patients to look for
alternative solutions.
In the given scenario, a North India‑based ayurvedic
treatmentcenterhasreportedsignicantandsustainable
relief in patients of different variants of pancreatitis using
an Ayurvedic Treatment Protocol (ATP). Information
related to 1750 patients diagnosed with recurring
acute/CP enrolled between July 1997 and July 2023 was
analyzedtorevalidatetheefcacyofthetreatmentand
observe its effect in the treated patients.
METHODOLOGY
Onethousandsevenhundredandftyconrmedcases
of acute/CP were enrolled for the treatment between
January 1997 and July 2023 in the North India‑based
ayurvedic treatment center. Upon enrollment, a detailed
medical history of each patient was taken. All of these
patients visited the treatment center with a clear
diagnosis made by their practicing gastroenterologists
after undergoing relevant investigations including blood
tests, ultrasound, computed tomography scan, Magnetic
Resonance Cholangio‑Pancreatography (MRCP), or
endoscopic retrograde cholangiopancreatography for
different variants of pancreatitis.
Before admission into the center, the enrolled patients
were asked to undergo fresh MRCP and other
investigations including hemogram, liver function,
kidneyfunction,lipidprole,glycosylatedhemoglobin,
serumVitaminD3andB12toconrmthediseasestatus,
and overall health condition before commencement of
ATP. They were then admitted for 3 weeks of supervised
indoor treatment at the center.
At the onset of ATP, each patient was dewormed using
tablet albendazole 400 mg.[14] The patients who had low
levels of Vitamin D3 (89%) and Vitamin B12 (70%) were
put on a weekly dose of 60,000 IU cholecalciferol syrup
and a daily supplement of methylcobalamin 1500 µg with
breakfast, respectively.[15,16] All conventional medicines,
including pancreatic enzymes, were stopped for all
patients from the start of the treatment. Patients suffering
from diabetes (29%) and hypertension (8%) were advised
to continue antidiabetic and anti‑hypertensive medicines
in consultation with their physicians.
Details of Ayurvedic treatment protocol
ATP is a combination of a regulated diet, lifestyle,
and few Ayurvedic formulations (Aahara, Vihara, and
Aushadhi). The main HMF used in the protocol is a
herbo‑mineral formulation,[17] which is a complex
compound prepared using processed metals/minerals
including copper, mercury, and sulfur in the presence
of lemon juice, and aqueous extracts of Luffa echinata
Roxb. and Clitoria ternatea L. The formulation showed
promisingresultsinbringingsignicantrecoveryin
advanced pancreatic diseases and is in practice in the
center since decades.
Other medicines were also prescribed based on the
individual symptoms and investigation reports of the
patients [Table 1]. Each patient was given a 1600–2200
calorie daily diet, rich in protein and dairy products,
divided into three meals and three snacks. The diet was
devoid of aerated drinks, caffeinated beverages, alcohol,
onion, tomato, garlic, refined flour, and packaged,
precooked, and reheated food. Patients were advised to
avoid any physical and mental exertion and get 8 h of
undisturbed sleep at night.
After the residential treatment for an average period of
21 days, the patients were discharged from the center
and it was suggested to continue the same treatment
until further suggestion. At follow‑up, each patient
was closely monitored over the phone or mail on daily
basis. By the end of the year, the patients were called for
physical, pathological, and radiological investigations.
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Prakash, et al.: Ayurvedic intervention in pancreatitis
International Journal of Ayurveda Research | Volume 5 | Issue 3 | July-September 2024 207
Observations
The 1750 enrolled patients had a chronicity ranging
from 1 month to 25 years. Thirty‑two percentage of
patientswerediagnosedforchroniccalcicpancreatitis,
26% for CP, 18% for recurrent acute pancreatitis, 8.5%
for necrotizing pancreatitis, 6% for acute on CP, 8% for
genetic pancreatitis, 1% for groove pancreatitis, and 0.5%
for autoimmune pancreatitis. Of these, about 81.93% were
male and 18.07% were females. The patients belonged
to different age groups. About 3.18% of patients were
less than 11 years of age, 11.94% of patients were in the
age group of 11–18 years, 75.41% of patients were in the
age group of 19–45 years, and 9.47% of patients were
more than 45 years old. Abdominal pain (97%) and
indigestion (98%) were the most common presenting
symptoms. Other symptoms included vomiting (82%),
weight loss (76%), and anorexia (44%). These patients
belonged to different states of India, with a maximum
of 18.05% of patients from Uttar Pradesh, followed by
10.29% from Maharashtra and 7% from Delhi. About
2.53% of patients were residents of other countries. About
80.93% were nontobacco users, 66.87% were nonalcoholic,
and 93.20% had no family history of the disease.
Among the enrolled, 916 of the 1750 have completed
1 year treatment, while 361 patients are on treatment.
Thirty‑nine patients did not start the treatment and
24 patients died during the treatment. Of these,
11 patients died due to complications of pancreatitis
or disease progression, 11 patients died due to disease
conditions unrelated to pancreatitis while one patient
died due to dengue and one died in a road accident.
Eleven patients were lost to follow‑up, three patients
reported progression of the disease, and 396 patients
dropped out and did not complete the treatment.
Sixty‑two percentage (246) of these patients reported
no improvement and stopped the treatment, 16% (63)
were noncompliant to treatment‑related advice and
treatment was stopped, 8% (32) of patients stopped the
treatmentduetonancialissues,7%(27)underwent
surgery and stopped ayurvedic treatment, 4% (16) of
patients reported discontinuation due to inadequate
care, and 3% (12) of patients stopped the treatment due
to complications related to other diseases.
The patients showed improvement in overall appetite,
energy, pain, stability in sugar levels, and general
well‑beingwithinthe rst3weeksof commencement
of the treatment. The patients who completed 1‑year
treatment showed marked improvement in their
frequency of attacks from 2781 to 189 and hospitalizations
from 1530 to 36 [Figure 1]. Of the 916 patients who
completed 1‑year treatment, 901 patients are leading
healthy disease‑free lives [Figure 2].Therstpatient,
enrolled in 1997, has completed 26 years long disease‑free
survival and is healthy. Nine patients dropped out due to
relapse of the disease postcompletion of ATP. Six among
the admitted patients were died. Five of these patients
died due to disease relapse and one due to cardiac
arrest. Except this, no adverse effects were reported
till date with the use of the adopted ATP. The renal
functions,hepaticfunctions,lipidprole,andhemogram
conductedatregularintervalsrevealednormalproles
indicating safety nature of the treatment regimen.
Effect on carbohydrate antigen 19‑9 levels
Carbohydrate Antigen 19‑9 (CA19‑9) is a tumor marker
for pancreatic cancer and is also known to promote
pancreatitis and pancreatic cancer.[18] The normal value
of CA19‑9 in the blood is <37 units/1 mL whereas levels
above300U/mLbloodareconsidereddenitesignsof
pancreatic cancer.[19]
Data on 148 patients of pancreatitis with elevated
CA19‑9 levels (ranging: 37–10,000 U/mL) has shown
that ATP brings a reduction in CA19‑9 levels. Mean
values before and after treatment were 378.77 and 128.36,
respectively (P = 0.005). Eighteen of these patients had
CA19‑9 levels more than 300 U/mL. The downtrend
isseentobeginwithintherst10daysoftreatment.
An increase in CA19‑9 levels after starting ayurvedic
treatment was seen in only 2.7% of cases.
DISCUSSION
Patients who were a part of the study had been
suffering from repeated attacks of pancreatitis and were
hospitalized multiple times for disease management.
Ayurvedictreatmentwasabletobringasignicant
Table 1: Details of formulations prescribed
Formulation Daily dose Anupana (~adjuvant) Percentage of patients
HMF 4 mg/kg body weight, divided into three doses Protein rich diet/malai 100
Prak‑20 capsule 60 mg/kg body weight, divided into three doses Water 90
Rasona vati 500 mg, 1–2 tablets thrice after meals Warm water 70
Chitrakadi vati 250 mg, 1–2 tablets thrice before meals Without water 30
Kamadudha rasa powder 125 mg, twice or thrice 15 min before meals Mishri 60
Sootashekhara rasa 250 mg, 1–2 tablets twice a day on empty stomach Water 40
Narikela lavana 1 g, once‑twice a day on empty stomach Buttermilk 40
Hingwashtaka churna 250–500 mg, thrice a day after meals Warm water 20
HMF=Herbo‑Mineral Formulation
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208 International Journal of Ayurveda Research | Volume 5 | Issue 3 | July-September 2024
reduction in the number of attacks and hospitalizations.
ThepreliminaryndingsindicatethattheATP,which
is comprised of ayurvedic formulations along with a
regulated diet and lifestyle has some potential role in
the treatment of pancreatitis.
There is a global upsurge in the incidences of pancreatitis.
India that reported its first case in 1937, also has
substantial number of cases of pancreatitis.[20] Initially,
the disease was thought to be more prevalent in southern
states of India due to certain dietary factors. However,
a hospital‑based clinical study has reported that the
incidences of pancreatitis are well scattered all over India
with a maximum percentage from northern states of India.
Thesamendingsweredrawnfromthepresentstudyas
well. Furthermore, contrary to the belief that pancreatitis
is more prevalent among alcoholics, tobacco users, and
people with a family history of the disease, the analysis of
datacollectedfromenrolledpatientsdoesnotreectthis
trend. The type most prevalent is termed as TCP, where
incidences are more prevalent among nonalcoholics with
the average onset of disease at the age of 24 years. Protein
malnutritionandmineraldeciencyareattributedas
major causes of TCP in the Indian scenario.[7]
The main medicine used in the treatment, is a herbo‑mineral
formulation (HMF), that has shown pancreatitis‑preventive
properties in experimental studies.[21] Rasona vati,
Chitrakadi vati, and Hingwashtaka churna are given for
Deepana (~carminative) and Pachana (~digestive) to aid
digestion and increase appetite. Prak‑20 capsule is used
as hepatoprotective, Sootashekhara rasa is given in patients
having gastritis or Annadrava shoola, Narikela lavana was
given if patient had tenderness in the hypochondrium
region (over gallbladder area) during clinical examination,
and Kamadudha rasa was given in patients with nausea
and vomiting.
Ayurveda is based on the principles of Aahara,
Vihara, and Aushadhi (~diet, lifestyle, and medicines).
Interestingly, 92% of all these patients who undertook
ayurvedic treatment were dependent on daily pancreatic
enzyme supplements before commencing ATP and were
on a fat‑ and protein‑restricted diet. All conventional
medicines for pancreatitis were stopped at the start of
ATP and patients were given a 1600–2200 calorie daily
balanced diet consisting of dairy products, protein, and
moderate fat. Ayurveda talks about the importance of
diet and lifestyle in diseases of the abdomen and liver.
These patients were advised to avoid physical and mental
exertion. Another principle of Ayurveda emphasizes the
importance of quality sleep in disease management.[22]
Patients were advised to take 8 h of undisturbed sleep
at night and avoid sleeping during the day.
The combination of these medicines along with the diet
andlifestyleprescribedhasshownsignicanteffectand
needs to be probed further.
CONCLUSION
ATP deals with the therapeutics of processed metals in
combination with regulated diet and lifestyle and should
be explored further as a novel treatment in the prevention
and cure of pancreatitis.
Financial support and sponsorship
Nil.
Conicts of interest
Therearenoconictsofinterest.
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