Rajiv Gandhi University of Health Sciences s176

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BENGALURU.

SYNOPSIS BY

Dr. ASHWINI

FOR THE DEGREE OF AYURVEDA DHANVANTHARI M.S. AYURVEDA IN SHALYA TANTRA. 2011

TITLE OF THE TOPIC

“MANAGEMENT OF CHOLELITHIASIS WITH PANEEYA KSHARA – AN OBSERVATIONAL CLINICAL STUDY”

NAME OF THE INSTITUTE GOVERNMENT AYURVEDA MEDICAL COLLEGE, DHANVANTARI ROAD, BENGALURU – 09, KARNATAKA.

1 RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

KARNATAKA, BENGALURU.

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION 1 NAME OF THE CANDIDATE Dr. ASHWINI AND ADDRESS D/O G.C. ONKARAPPA, ‘VATHSALYA’, VINAYAKA NAGARA, TARIKERE DIST-CHIKKAMAGALORE PIN-577228 2 NAME OF THE INSTITUTION GOVERNMENT AYURVEDIC MEDICAL COLLEGE, POST GRADUATE DEPARTMENT OF SHALYATANTRA, DHANVANTARI ROAD, BENGALURU -560009 3 COURSE OF STUDY AND AYURVEDA DHANVANTHARI SUBJECT MS(AYU) SHALYA TANTRA 4 DATE OF ADMISSION TO THE 15/11/2010 COURSE 5 TITLE OF THE TOPIC “MANAGEMENT OF CHOLELITHIASIS WITH PANEEYA KSHARA – AN OBSERVATIONAL CLINICAL STUDY”

FROM: Dr. ASHWINI

2 First MS(AYU), Dept of SHALYA TANTRA Government Ayurvedic Medical College, Bengaluru – 560009

TO: THE REGISTRAR Rajiv Gandhi University of Health Sciences Bengaluru - Karnataka

Through: THE PRINCIPAL AND H.O.D. OF POST GRADUATE STUDIES IN SHALYA TANTRA, Government Ayurvedic Medical College, Bengaluru – 560009

Respected Sir,

Sub: Submission of completed proforma for Registration of Subject for Dissertation

I request you to kindly register the below mentioned subject against my name for the submission of Dissertation to the Rajiv Gandhi University of Health Sciences, Bangalore, for partial fulfillment of M.S. (Ayurveda) in Shalya Tantra.

TITLE OF THE DISSERTATION:

“MANAGEMENT OF CHOLELITHIASIS WITH PANEEYA KSHARA – AN OBSERVATIONAL CLINICAL STUDY”

Hereby I am enclosing completed proforma for registration of the subject for Dissertation.

Thanking you

Place: Bangalore Yours sincerely

Date: Dr. Ashwini 6. BRIEF RESUME OF INTENDED WORK

3 6.1 Need For the Study : Cholelithiasis (gall stone) is a crystalline concretion formed within the gall bladder by accretion of bile components. Cholecystectomy, the surgical removal of gall bladder is one of the common most surgical procedures of abdomen in western world which is because of high incidence of gall stones. The prevalence of cholesterol cholelithiasis in Western countries is about 10-20% and every year 1-3% of people develop gall stones with symptoms or complications requiring cholecystectomy. An epidemiological study shows that in India prevalence of cholelithiasis is about 4%.It is rare in first two decades.Incidence gradually increases after 20 years. It reaches peak in 5th and 6th decades. Women are affected more than men,and the ratio is 4:1. It is said that the gallstons are more in fat, fertile, forty and female. A study shows that more than 85% of people having gall stones will be asymptomatic even for years. Such gall stones called ‘silent stones’ and they believe that they do not require any treatment. But in such asymptomtic gall stones,after a long follow up, 50% has turned symtomatic and serious complications have occured in 20% of cases. The most dreaded complication of asymptomatic gall stone is carcinoma of gall bladder. 6 Hence to prevent such complications, early management of gall stones if found accidentally by USG or X-Ray abdomen, is beneficial. Presence of stones in gall bladder, either symptomatic or asymptomatic may lead to acute or chronic cholecystitis and presence of stones in other parts of biliary tract can cause obstruction of bile ducts, which can lead to serious conditions as ascending cholangitis or pancreatitis. Any of these conditions can be life threatening and are considered to be surgical emergencies and require compulsory cholecystectomy. Cholecystectomy has 99% chance of eliminating recurrence of Cholelithiasis. However about 10-15% of population may develop a condition called Post Cholecystectomy Syndrome, which includes gastrointestinal distress and persistent pain in upper right abdomen, as well as 10% chance of developing chronic diarrhoea due to lack of gall bladder. The drugs to dissolve gall stones or other non surgical methods are still considered experimental in modern medicine. Cholesterol gall stones can sometimes be dissolved by oral Ursodeoxycholic acid, but it may be required that the patient takes this medication for 2

4 years. Gall stones may recur however once the drug is stopped. At the same time it may produce side effects like mild diarrhoea and temporarily raised levels of blood cholesterol and liver enzyme transaminase. Gall stones can be broken up using a procedure called the Lithotripsy, however this form of treatment is suitable only when there is a small number of gall stones. By over all view it is very much clear that treatment prescribed in modern medicine for Cholelithiasis is far from satisfactory and is often accompanied with several side effects. So there is large scope in Ayurveda in the field of management of Cholelithiasis. Acharya Sushruta very specifically indicates Paneeya Kshara in the management of Ashmari and the Kshara due to its ksharana property can easily dissolve Ashmari.1a Hence in Cholelithiasis, considering it as Pittashayagata Ashmari, use of Paneeya Kshara prepared of Surya kshara and Navasadara being made here is expected to contribute towards better management of Cholelithiasis.

In this study the formulation used is an Anubhootha yoga which has been practiced successfully. And the pilot study is also conducted for the same in five patients. This study can be proved superior, as it prevents need for surgery and results can be observed with in short course of time.The duration of medication is also very less and has no comlpications.

6.2 Review of literature:

Ayurvedic Review:

5 Cholelithiasis can be considered as Pittashaya Ashmari, but there is no direct reference of this condition in Ayurvedic literature.

1) Sushruta explained pittashaya as one of the Saptha Ashayas in shareera sthana

5th chapter.

आशययाससस वयासयाशययः पपितसयाशययः शशश्लेषषयाशययो रकसयाशययः आषयाशययः पिकवयाशययो

1b षमतयाशययः सतस्त्रीणयाणां गरयार्भाशययो अषष्टषयोइतस।

2) Vagbhata while explaining samprapti of Ashmari says that Ashmari is formed in Basti as Rochana is formed in Pittashaya of cow. So the Ashmari formed in Pittashaya of humans, in similar to Gorochana can be considered as Pittashaya Ashmari.

पवशयोषयश्लेस त बसससगसणां सशसकणां षमतणां सपपितसणां पिवनयः कफणां वया।

2 यदया सदया अशषयसर्भापिजयायसश्लेस स कषश्लेण पपितसश्लेसषवव रयोचनया गयोयः॥

3) Acharya Chakrapani while commenting on shakhashritha kamala,says that kamala is produced due to obstruction of shakhashritha pitta entering to koshtha by shleshma, which can be correlated to the pathogenesis of gallstones obstructing biliary tract.3

4) Sushruta specifically indicates Paneeya Kshara in Ashmari in sutra sthana 11th Chapter.

पियानस्त्रीयससस

1a गरगसलषयोदरयासगनसङगयाजस्त्रीणयार्भारयोचकयानयाहशकर्भारयाशषययार्भाभयनसरपवद्रधधिकक मषपवषयाशर्भाससमपियसजयसश्ले ।

5) Acharya Sri Sadananda Sharma has indicated Surya Kshara in Ashmari in Rasa Tarangini 14th chapter 36th shloka4.

6) Acharya Vagbhata mensions navasadara as kshara in Rasarathna Sanucchaya

6 3rd chapter 34th shloka5.

Modern Review: Definition: Gall stones are hard deposites that are similar to pebbles or stones that can develop in gall bladder. Presence of stones in gall bladder is referred to as Cholelithiasis and if stones migrate in to ducts of biliary tract the condition is referred as Choledocholithiasis8. Charecteristics of gall stones: Gall stones can vary in size from as small as grain of sand to as large as golf ball. Gall bladder may contain a single stone or many smaller ones. Pseudoliths, sometimes referred to as sludge are thick secretions that may be present within gall bladder, either alone or in conjugation with fully formed gall stones8. Signs and Symptoms: Gall stones may be asymptomatic even for years. Symptoms commonly begin to appear once the stone reaches a certain size ( >8mm ). Charecteristic symptom of gall stones is a ‘gall stone attack’, in which person may experience intense pain in upper right side of abdomen, often accompanied by nausea and vomitting that steadily increase for approximately 30 min to several hours. A patient may also experience referred pain between shoulder blades or below right shoulder. Attacks often occur after fatty food or at night time ( gall stone colic ). Feeling of fullness after fatty food, belching and heart burn ( flatulent dyspepsia ) are also experienced in this condition.8

Previous works done 7: 1. 1974 – Batro O.P - Role of Ayurvedic medicine in the management of Pittashmari (Cholelithiasis) –Shalya Tantra, B.H.U., P.No.80, Sl.No – 629

2. 1998 – Panigrahi H.K. – Clinical study on Rohitakaarishta ( R.A.Y.S ) in reference to Cholelithiasis – Shalya Tantra, Jaipur, P.No. 137, Sl.no - 934

3. 1998 – Thasneem Qudsiya M. - A clinical study on management of Pittashmari (Cholelithiasis) using Narikela lavana with Rohitaka choorna –Shalya Tantra, Bangalore, P.No. 181 , Sl.No - 133

7 4. 2000 – Badve Y.R. – Clinical study of Yakrit Shoolanashini vati w.s.r. to Cholelithiasis – Shalya, Jaipur, P.No. 137 , Sl.No.-939

6.3 Objective of the study : - To evaluate the efficacy of Paneeya kshara in the management of cholelithiasis - To survey the number of patients of cholelithiasis attending OPD of Shalya tantra of SJIIM Hospital, Bengaluru.

7. METHODOLOGY:

7.1 Source of Data:

8 Patients with classical features of Cholelithiasis and those who are incidentally found to be having gallstones through their USG reports of other purposes, shall be selected from O.P. and I.P. of Shalya tantra department ,Shri Jayachamarajendra Institute of Indian Medicine Hospital (Teaching Hospital of G.A.M.C), Bangalore.

7.2 Method of collection of data: Patients of either sex diagnosed as having Cholelithiasis, based on inclusion criteria will be selected.

Inclusion criteria: Patients presenting with symptoms like Pain in right upper quadrant of abdomen, Referring pain to the inferior right angle of scapula, Vomiting, Nausea, Flatulent dyspepsia, Recurrent indigestion and also asymptomatic patients who are diagnosed to have gallstones, accidentally by USG.

Exclusion criteria:

1) Patients who are contraindicated (Ayogya) for Paneeya kshara by Sushrutha. 2) Immunocompromised patients. 3) Patients with gall stones associated with complications such as acute obstructive cholecystitis, acute pancreatitis, liver failure, carcinoma. of gallbladder. 4) Uncontrolled other systemic disorders.

Sampling size Any number of patients(not less than 20) attending OPD of Shalya tantra , SJIIM Hospital, Bengaluru,diagnosed to have gallstones during the period of my study will be taken randomly for the study in a single group, and they are administered the compound preperation of navasadara and suryakshara. Study design : This is an observational clinical study. 1) Patients who fulfill the inclusion criteria are taken.

9 2) Patients will be administered 250mg of compound preperation of Surya kshara and Navasadara which is mixed with 250ml of Narikela jala , twice aday.. 3) This medicine is given for 5 days and after 30 days USG abdomen is taken to confirm the efficacy of treatement.. 4) The findings will be recorded in a special proforma prepared giving due regard to the past history, present history, family history, history of previous illness, history of previous medications taken & personal history. Preparation of yoga 1) 100gm of surya kshara(potassium chloride) is taken and immersed in nimbuswarasa and kept under sun for complete drying and after drying the same procedure is repeated for 10 times. 2) 100gm of navasadara(ammonium chloride) is taken after saamanya shodhana. 3) Both of these are taken and mixed well with required amount of eranda taila and mardana is done. After it atains paste like consistancy, it is taken in sharava samputa and puta is given with 15 - 20 upalas and urdhwapathana sathwa of this is collected for administration. Mode of administration 250 mg(2 gunja) of above said yoga is dissolved in 250 ml of naarikelajala and kept for 12 hours and given for administration before food.. It is followed twice daily for 5 days.

Observational period: 60 days.

Duration of study : 18 Months.

10 STUDY DRUG MODE DOSE DURATION TIMES OF ANUPANA PATTERN OF ADMINISTRATION ADMINIS RATION

OBSERVATIONAL PANEEYA ORAL 250mg 5 DAYS TWICE A DAY NARIKELA CLINICAL STUDY KSHARA BEFORE FOOD JALA

Assessment criteria: Assessment will be based on the following parameters, A. Subjective parameters: . Pain in right upper quadrant of abdomen . Reffered pain to inferior angle of right scapula . Vomitting . Nausea . Flatulent dyspepsia . Reccurrent Indigestion B. Objective parameters: . USG Abdomen will be taken before the treatment, on 30th day and 60th day after the treatement.

Suitable gradations shall be made for above parameters and the data obtained before the treatment and after the treatment will be analysed, using appropriate statistical methods and final conclusion will be drawn.

Investigations : Ultrasonography of Abdomen , will be taken before the treatment, on 30th day and 60th day after the treatement.

11 7.3 Does this study require any investigations or intervention to be Conducted on patients or other humans or animals? If so please Describe briefly:

 YES, the study will be a clinical study.

7.4 Whether the ethical clearance has been obtained from the Institution? : YES

12 8. List of Bibliographic reference: 1. Acharya Sushruta.Sushruta Samhita with Nibandha Sangraha Commentary of Sri Dalhanacharya and Nyayachandrika Panjika of Sri Gayadasacharya on Nidana sthana, Edited by Vaidya Yadavji trikamji acharya and rest, Published by Chaukhamba Orientalia. Edition 2010 ,pp 824., a) Sutra sthana 11th chapter /8th shloka, P.No.- 46 b) Shareera sthana 5th chapter/8th shloka, P.No.- 364

2. Acharya Vagbhata. Astanga Hridayam with Commentaries Sarvanga Sundari of Arunadatta and Ayurveda Rasayana of Hemadri. Collated by Dr.Anna Moreswar Kunte and Krishna Ramchandra Shastri Narve. Edited by pt. Bhisagacharya Harishastri Paradkar Vaidya. Published by Krishnadas academy Varanasi .Reprint 2000.pp956. Chikitsa Sthana 26th chapter /36thShloka,

3. Acharya Charaka. Charaka samhita with Ayurveda prakashika commentary of Chakrapani, published by Chaukhamba Orientalia. Edition 2010 ,chikitsa sthana 16th chapter, 42 Shloka

4. Pranachaarya Sri Sadananda Sharma. Rasa Tarangini with Prasadini commentary of Sri Haridutta Shastri compiled by Kaashinatha Shastri, with Rasavijnana hindi commentary by Dharmanada Shastri. Published by. Chaukhamba Orientalia.. Edition 2000 ,14th chapter/36th shloka P.No 333

5 Acharya Vagbhata. Rasa Ratna Samucchaya with Tatvartha Bodhini commentary of Sri Dharmananda Sharma and compiled by Atrideva Gupta Vidyalankara. Published by Chaukhamba Orientalia. 3rd chapter/134th shloka P.No 57

6. S.Das. Consiced text book of surgery, Published by S.Das. Edition 6th,2010,46th Chapter,P.No.798.

7. Vaidya Baghel MS.Research in Ayurveda-2nd edition Jamnagar:Mridu Ayurvedic Publication and Sales;2005.pp381, P.No.- 80,137,181,137. 8. www.wikipedia.com.

13 9. Signature of the Candidate

10. Remarks of the Guide

11. Name and DR. AHALYA SHARMA Designation of PROFESSOR Guide GAMC, BENGALURU- 09

11.1 Signature of guide

11.2 Co-Guide if any

11.3 Signature of Co-Guide

11.4 Name & designation of HOD DR. B.N. VENKATESH PROFESSOR GAMC, BENGALURU-09

11.5 Signature of HOD

12.1 Remarks of Principal

12.2 Signature of Principal