From:

Dr.Santhosh. T, B.A.M.S.

1st Year M.D (Ayu),

Department of Post Graduate Studies in Kaya Chikitsa,

AyurvedicMedicalCollege and PG Centre, Davanagere – 577566

To,

The Registrar,

RajivGandhiUniversity of Health Sciences,

Bengalooru, Karnataka.

Through:The Principal & Head of the Department of Kaya Chikitsa,

AyurvedicMedicalCollege and PG Centre, Davanagere.

Respected Sir/Madam,

Subject: Submission of completed proforma of Synopsis for Registration of the Dissertation.

I request your kind office to register the below mentioned subject against my name for the submission of dissertation to the Rajiv Gandhi University of Health Sciences, Bangalore for the partial fulfillment of M.D (Ayu).

Title of the Dissertation:

“ACOMPARITIVE CLINICAL STUDY OF BHUNIMBADI KWATHA AND PHALATRIKADI KASHAYA IN THE MANAGEMENT YAKRIT VIKARA WITH SPECIAL REFERENCE TO ALCOHOLIC LIVER DISEASE.

Here with I am enclosing completed proforma of Synopsis for registration of the dissertation.

Yours faithfully,

Place:Davanagere Date: 30-04-2012 (Dr.Santhosh. T)

RAJIVGANDHIUNIVERSITY OF HEALTH SCEINCES, BENGALOORU, KARNATAKA.

ANNEXURE – II

Completed proforma for Registration of Subject for Dissertation.

1. Name of the Candidate:DR. SANTHOSH .T

Address (In Capital)1ST YEAR M.D (Ayu)

S/O THIMMESHAPPA .R,

# 678 F/74, 3RD CROSS, 4THMAIN,

SHIVAKUMARASWAMY

LAYOUT 2ND STAGE ,

DAVANAGERE.

KARNATAKA. 577005.

2. Name of InstitutionAYURVEDICMEDICALCOLLEGE & PG CENTRE,

NEAR BATHILAKE, P.B.ROAD, DAVANGERE – 577566.

3. Course of StudyAYURVEDA VACHASPATI.

M.D (Ayu) IN KAYA CHIKITSA.

4. Date of Admission16-08-11

5.Title of Topic “A COMPARITIVE CLINICAL STUDY OF BHUNIMBADI KWATHA AND PHALATRIKADI KASAHAYA IN THE MANAGEMENT YAKRIT VIKARA WITH SPECIAL REFERENCE TO ALCOHOLIC LIVER DISEASE”.

6. BRIEF RESUME OF INTENDED WORK:

6.1 Need for the study.

LIVER – the second largest organ in our body performs various vital function and also plays crucial role in alcohol and drug metabolism. Nowadays consumption of alcohol has become a passion and increased day by day due to craze and curiosity in youths , peer pressure, to imitate elders ,social parties labour strata of population due to social myths & even women also landed upon having alcohol. This gradually turning to its addiction(minimum 2 out of 10 people) causing serious effect on liver leading to Alcohol Liver Disorder (ALD) , which has turned up as a major health problem in India.

According to Ayurveda, organ Yakrit(Liver) is source of Raktavaha srotas and it is involved in many diseases with various etiology since ancient times. Acharya Bhavamishra for the first time introduced yakrit vikara , a detailed description of the disease with its classification and chikitsa is available in treatise Bavaprakasha. Even though there is no direct reference regarding madya as a causative factor for yakrit vikara in classical texts .Today the advanced studies and development in modern science confirms alcohol is the most common hepatotoxin, whose metabolism creates profound liver cell derangements. ALD has three stages viz fatty infiltration, alcoholic hepatitis and alcoholic cirrhosis and is 5th leading cause of death.ALD does not occur below a threshold of 21 units in women & 28units/week in men.An average alcohol consumption to develop cirrhosis is 16 units/day for an average of 8 yrs. There is no specific remedy in allied science for this disease.Abstinence from alcohol itself is an prime without which other therapies are of limited value.The prevailing situation obviously call for revalidation of ayurvedic formulations,which made me to study and evaluate the efficacy of Bhunimbadi kwatha and phalatrikadi kashaya in treating the same.

6.2 Review of Literature.

  • The vivid description of yakrit vikara is explained with regards to its nidana , samprapti , lakshana, bheda and chikitsa in Bhavaprakasha .1
  • The description of Bhunimbadi kwatha is available in Bhaishajya ratnavali .2
  • The description of phalatrikadi kashaya is available in bhaishajya ratnavali .3

Prevalence, pathology, Symptomatology, of Alcoholic liver disease are revived in,

  • API Text book of medicine.4
  • Harrison’s principles of internal medicine.5
  • Harshamohan’s text book of Pathology.6
  • Davidson’s principles of practice of medicine.7
  • Merk’s manual of diagnosis and therapy.8

Previous work done:

  • A comparitive clinical study to evaluate the effect of Tablet Heptin Forte and Parpata Guduchyadi Kashaya in Yakrit Vikara w. s. r to Alcoholic Liver Disease.A dissertation work done by Dr, Kiran Kumar Mutnali Govt ayurvedic medical college Mysore in 2008.
  • Comparative clinical study to evaluate the efficacy of panchanimbhacharna and quatha of indigenous drugs in the management of madhyapanajanya yakrit vikara wsr to Alcoholic liver disorder by Dr Sowmya bhat ,GAMC Mysore in 2010.

6.3. Objectives of the study.

  • To evaluate the efficacy of phalatrikaadi kashaya in the management of Alcoholic liver disease.
  • To evaluate the efficacy of Bhunimbadi khwatha in the management of alcoholic liver disease.
  • To compare the results of phalatrikaadi kashaya and bhunimbadi kwatha in the management of ALD.

7. Material and Methods.

7.1. Source of Data:

The study will be carried out selecting patients diagnosed ALD from OPD,IPD and special camps conducted in AMCH ,Davanagere.

7.2 Method of collection of data –

Patients of either sex will be selected randomly based on chronicity of ethanol history symptoms of yakrit vikara(Alcoholic Liver Disease), and Liver function test values.

The total number of patients taken for study will be 40.

The patients selected for study will be divided into 2 groups.

Inclusion criteria:

  • Patients will be selected having chronic alcohol history(minimum 5 yrs) with raised Liver function test values and findings of USG Abdomen.
  • Patients between the age group of 25-70 yrs, irrespective of sex and occupation presenting with the signs and symptoms of ALD.

Exclusion Criteria:

  • Any disease or condition that intervenes with the treatment like ischemic heart disease, chronic renal failure, myxodema, nephrotic syndrome , hypertension, hepatocellular or any other carcinoma will be excluded.
  • Patients having uncontrolled diabetes will be excluded.
  • Patients whose USG – abdomen showing acute alcoholic hepatitis & cirrhotic changes.
  • Patients exhibiting ascitis, potal hypertension,encephalopathy,variceal bleed, HBsAg and HCV (+)ve.

Diagnostic criteria:

  1. A clinical diagnosis of yakrit vikara will be made on the basis of signs and symptoms after collecting alcohol consumption history for minimum 5yrs .
  2. Elevated liver enzymes viz, SGOT(AST), SGPT(ALT) and GGT. Abdominal ultrasound .
  3. Yakrit Vriddhi(Hepatomegaly).

Study Design: It’s a comparative Clinical study with pre-test and post-test design.

Sample Size: A minimum of 40 patients will be selected for the study and will be divided into 2 group’si.e. Group-A & Group-B each consisting minimum 20 patients.

  • Group A: Patients will be administered with Phalatrikadi kashaya 30ml twice a day for 2 months.
  • Group B: patients will be administered with Bhunibadikwatha 30ml twice a day for 2 months.

Anupana:Jala

Duration: 60 days.

Follow up: 1 month after treatment.

Parameters of the study:

  1. Based on the signs and symptoms and laboratory investigations.
  2. Assessment of the condition of the patient will be done before during and after the treatment.
  3. Data will be analysed by applying Pair and unpair t- test .

7.3 Does the study requires any investigation or interventions to be conducted on patients or other animals? If so describe briefly.

YES

Study will be conducted on patients withAlcoholic liver disease.

Investigations:

L.F.T:

  1. SGOT
  2. SGPT
  3. GGT
  4. Serum bilirubin – Total bilirubin , Direct and Indirect bilirubin
  5. Hb%,TC,DC,ESR.
  6. USG abdomen.
  7. Urine routine.

7.4. Has ethical clearance been obtained from your institution in case of 7.3?

Yes, certificate enclosed.

YES

8. List of references:

  1. Bhavamishra, Bhavaprakasha with Vidyotini Hindi Commentary by Pt.B.S Sharma part 2 seventh edition 2000 Chaukhamba Sanskrit Samsthana Varanasi, chapter 33 page no 348-350.
  2. Govinda das . Panduroga Chikitsa Prakarana ,Bhaishajya Ratnavali with Vidyotini Teeka by Ambika Datta Shastry, Chaukhamba Publications Varanasi edition chapter no 6 / shloka no 31 and chapter12/ shloka no 22. Page no 269 and 145respectively.
  3. Davidson Priciples and Practice of Medicine, Edited by Christopher Haslett et.al. Published by Churchill Livingstone, Edinburgh, London, New York, 18th Edition, 1999, chapter 23, pg no 716-717.
  4. Harsh Mohan (1994) Text Book Of Pathology , 3rd edition, Editor Harsh Mohan , Publication Jaypee Brothers Medical Publishers (p) ltd, New Delhi, pp 619.
  5. Harrison’s Principles of Internal Medicine 17th edition 2011,
  6. API Textbook of Medicine published by the association of physicians of india , 7th edition 2003Edited by siddarth shah , section 12 chaptr 10 pge no 606.
  7. Merk’s manual of diagnosis and therapy, section 3 – chapter25.
  8. Indian Medicinal Plants,edited by C.P.Khare published by springer reference.

9. Signature of the student:

10. Remark of the Guide:

11. Name & Designation of

11.1 Guide :DR. GNANESWARA . L.M . M.D [AYU.]

ASST PROFESSOR, DEPARTMENT OF POST GRADUATE STUDIES IN KAYA CHIKITSA, AYURVEDICMEDICALCOLLEGE & PG CENTRE, DAVANGERE.577566.

11.2 Signature:

11.3 Head of the department: DR. JAYANTHI.C M.D [AYU.]

PROFESSOR & H.O.D DEPARTMENT OF POST GRADUATE STUDIES IN KAYACHIKITSA, AYURVEDICMEDICALCOLLEGE & PG CENTRE, DAVANGERE. 577566.

11.4 Signature:

12. 1Remark of the Chairman :

Principal.

12.1 Signature:

1