From,

Dr. SAWANT SNEHA SURESH.B.A.M.S

I MD (Ayu),Department of Post Graduate Studies in kayachikitsa,

GovernmentAyurvedaMedicalCollege,

Mysore-570021

To,

THE REGISTRAR,

RajivGandhiUniversity of Health Sciences,

Bangalore-41, KARNATAKA.

Through,

The Principal and Head of the Department of PG Studies in Kayachikitsa.

GovernmentAyurvedaMedicalCollege,

Mysore-570021.

Respected Sir,

Subject:-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 Rajiv Gandhi University of Health Sciences, Bangalore for the partial fulfillment of M. D. (Ayurveda) in Kayachikitsa.

Title of theDissertation

“A CLINICAL STUDY TO EVALUATE THE COMBINED EFFECT OF MUSTADI CHOORNA & VIDANGADI KWATHA IN HYPERTRIGLYCERIDEMIA VIS-À-VIS BAHU ABADDHA MEDAS.”

Herewith I am enclosing completed proforma for Registration of the subject for Dissertation.

Thanking you,

Place: Mysore Yours Faithfully,

Date

[Dr. Sawant Sneha Suresh]

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

KARNATAKA, BANGALORE.

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. NAME of the Candidate Dr. SAWANT SNEHA SURESH

and ADDRESS: I M.D. (Ayu)

DEPARTMENT OF PG STUDIES IN

KAYACHIKITSA,

GOVERnMENT AYURVEda

medical college

MYSORE 21.

D/OMr. SURESH B. SAWANT

1 D, 505 NEEL GANGA CHS,

SHANKARRAO NARAM PATH,

HANUMAN LANE, LOWER PAREL

MUMBAI 400013.

2. NAME of INSTITUTION: Government Ayurveda

MEDICAL COLLeGE AND

HOSPITAL, MYSORE 21

3. COURSE of Study & SUBJECT:M.D. (Ayu) IN KAYACHIKITSA

4. DATE of Admission to Course:9-10-2012

5. TITLE of the dissertation:

“A CLINICAL STUDY TO EVALUATE THE COMBINED EFFECT OF MUSTADI CHOORNA & VIDANGADI KWATHA IN HYPERTRIGLYCERIDEMIA VIS-À-VIS BAHU ABADdHA MEDAS.”

6.BRIEF RESUME OF THEINTENDED WORK.

6.1) Need for theStudy:

The emerging 'Lifestyle disorders' such as obesity, arthritis, cancer, cardiovascular diseases, diabetes are life threatening health problems, leading to a major cause of deaths in recent years. The risk group being people above 40 yrs of age.

As per National Cholesterol Education Program Adult Treatment Panel (NCEP ATP III) guidelines, a normal triglyceride level is 150 mg/dl. In India,prevalence of triglycerides level >150mg is 3.4%.1 As per recent researches it is found that hypertriglyceridemia to be an independent risk factor for majority of coronary diseases even after controlling LDL & HDL, cholesterol.2

As per National Commission on Macroeconomics and Health (NCMH)there would be around 62 million patients with CAD by 2015 in India. Amongst them 23 million would be younger than 40 yrs.3 These statistics increases responsibility of the physician to a great extent in indentifying the cause & treating it effectively.

Though, there is no precise terminology for hyperlipidaemia mentioned in the Ayurvedic classics, various scholars have used distinct nomenclature for the same like Rasagata Sneha Vriddhi, Rasa Raktagata Sneha Vriddhi, Medovriddhi, Medoroga, Medodosha & Bahu abaddha medas. A detailed study of hyperlipidaemia reveals its similarity to Bahu abaddha medas ( asthayi medo dhatu) on the basis of its Pathophysiology & this excessively increased Bahu abaddha medas4a when retained in the body for a longer time may result in further complications.

In contemporary science, management of triglycerides include lipid lowering drugs like statins, clofibrate etc which is proved to have many side effects. Besides this,Ayurveda has a wide range of herbal and mineral drugs which have anti-hyperlipidemic activity, which are to be proved scientifically by clinical trials. Most of the ingredients of Mustadichoorna4b mentioned in santarapaneeya adhyaya of charaka samhita and Vidangadi kwatha5 mentioned in sahasrayoga, have kaphavata hara, medohara and lekhana properties.Therefore this study is carried out to evaluate combined effect of both mustadi choorna and vidangadi kwatha on hypertriglyceridemia.

6.2) Review of literature

1] In Santarpaneeya adhyaya 23rd chapter of Charaka samhita,santarpanajanya vyadhis are mentioned, where medo vriddhi or sthoulya is one among them.4c

2] Nidana, samprapti, laxanas, of medoroga are mentioned in Charaka samhita vimanasthana 5th chapter4d, Sushruta samhita sutrasthana 15th chapter6, Madhava nidana uttarardha 34th chapter7.

3] Chikitsa and pathyapathaya of medoroga is mentioned in Charaka sutrasthana 21st chapter4e, Sushruta sutrasthana 15th chapter6, Astanga Hrudhaya sutrasthana 14th chapter8, Bhavaprakasha madhyama khanda 39th chapter9, Bhaishajaya ratnavali 39th chapter10.

4] The term bahu abaddha medas is mentioned in Charaka samita nidana sthana, prameha nidana, in roopa in 4th chapter.4a

5] The difference between medoroga and medodosha is mentioned in Sharangadhara samhita prathama khanda 7th chapter by adamalla in his commentary.11

6] Disorders of complex lipid metabolism and lipoproteins are mentioned in Davidson's Principle and Practice of Medicine,in Disorders of Blood lipids and Lipoproteins 12th chapter.12

7] Harrison's principle of Internal Medicine Chapter 236 describes Metabolic syndrome.13

8] Disorders of lipid metabolism is mentioned in API Text book of Medicine, Volume 2, 16th Chapter.14

9 ] Mustadi choorna is mentioned in charak samhita sutrasthana , santarapaneeya adhaya 23/21.4b

10] Vidangadi kwatha is mentioned in Sahasrayoga, Parishishta prakaran.5

6.3)Previous Work done:

1]Dr. C.K. Shashirekha, ‘ A comparative study to evaluate the effect of Shuddha Guggulu and Shodananga snehapana in Hyperlipidemia w.s.r. to Medoroga”, Dept of Kayachikitsa, GAMC Mysore 2006.

2]Dr. Sidaram M.Guled, “ A clinical Study on the effect of Moorchita tila Taila and Navaka Guggulu in Hyperlipidemia.” – Acomparative study, Dept of Kayachitiksa, GAMC Mysore, 2009.

3] Dr. Jayadev.S, A Comparative pharmaceutico clinical study of Shilajatu(Triphala Shodita & Gomutra Shodhita) and its effect on Medoroga, (IPGT & RA, GAU, Jamnagar, Dept of Kayachikitsa 2002.)

4] Dr. Umesh Sapra - " A clinical study of hyperlipidemia & effect of panchatiktaghana in its management A double blind study.", Dept of kayachikitsa (IPGT & RA, GAU, Jamnagar, 2003.)

5] Dr. Panchajam P.K., “ A study of the effect of selected modalities of yoga and naturopathy in the control of Hyperlipidemia.”, Government Ayurveda Medical college, Trivandrum.2003.

6.4)Objective of the study:

- To evaluate the combined effect of Mustadi choorna4b and Vidangadi kwatha5 in hypertriglyceridemia.

7. MATERIALS AND METHODS:

7.1) STUDY DESIGN:

Source of Data:

A minimum of 30 patients of either sex, aged between 18-70 years, fulfilling the diagnostic criteria will be selected from OPD, IPD, special camps in GAMC, Mysore, and other referrals from in and around Mysore. Patients will be incidentally selected.

7.2) Methods of collection of Data:

  • It is a pretest and post test design.
  • The Patients will be selected from the OPD & IPD of GAMC, Mysore, based on the diagnostic criteria, between age group of 18- 70 years, of either sex.
  • The Present Clinical study is an observational study comprising of 30 patients in a single group.

A) Diagnostic Criteria:

The diagnosis will be based on serological investigation i.e serum triglyceride level 150 mg/dl.

B) Inclusion Criteria:

Patients with serum triglyceridelevels 150 mg/dl of either sex, between the age group of 18-70 years will be selected for the study.

Both fresh and treated cases will be included.

C) Exclusion Criteria:

Pregnant & Lactating women will be excluded

Patients with major systemic disorders such as, uncontrolled diabetes, uncontrolled hypertension and with major systemic disorderssuch as Psycho-Neuro-Endocrinal disorders, Patients who have a past history of Myocardial Infarction, Stroke or Severe Arrhythmia, severe pulmonary dysfunction which interferes with the treatment will be excluded.

Parameters of the study:

1] Serological laboratoryinvestigations of serum triglycerides, will bedone before ( 0 th day) and after the intervention (31st day).

2] Data will be collected before and after the intervention.It will be compared and analyzed for the improvement and the results will be analyzed using suitable statistical methods.

STATISTICAL METHODS

  • Descriptive statistics.
  • Paired sample t – test.
  • All the statistical operations will be done through SPSS for Windows software.

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

YES

Investigations are done as per requirement. Thestudy requires intervention tobe conducted on patients. No study would be conducted on animals.

Investigations:

1] Blood investigations - Hb%, TC, DC, ESR, RBS.

2] Specific investigation – Serum triglyceride (12 hr fasting blood sample).

3] Urine investigations - Urine Sugar, microscopic, albumin.

INTERVENTION

Patients will be administered with Mustadi choorna4b 6 gms BD and Vidangadi kwatha 5 30 ml TID after food.

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

YES

8) LIST OF REFERENCES:

1) Rajmohan L etal, Association between isolated hypercholesterolemia, isolated hyper triglyceridemia and coronary artery disease in south Indian type 2 diabetic patients. Indian Heart Journal 2000; 52 (4) 400-406.

2) Cullen P, Institute for Arteriosclerosis Research, Central Laboratory, University of Munster, Germany 2000 PubMed- NCBI.

3) Ministry of Health and Family Welfare, Report of NCMH, Government of India; 2005.

4) Agnivesha, Charaka samhita, Acharya Vidyadhara Shukala &Prof. Ravidutta Tripathi, Hindi commentary, volume 1 Chaukhamba publications.

4a - nidanasthana, prameha nidana adhaya 4/7, pgno 502.

4 b - sutrasthana santarapaneeya adhaya 23/12 pg no 316.

4 c - sutrasthana Santarpaniya adhaya 23/12-13 pg no 316.

4 d - vimanasthana Srotovimana adhaya 5/15 pg no 590

4 e - sutrasthana Ashtoninditiya adhaya 21/21-28 pg no 301.

5) Anonymous, Sahasrayoga edited by Dr. K. Nishteswar, Dr. R. Vidyanath, Chaukhamba publications, Parishishta prakarana, pg no 401.

6) Sushruta, Sushruta Samhita, Nibandha sangraha and Nyayachandrika commentary edited by Vaidya Yadavji Trikamji Acharya, Varanasi, Choukambha Orientalia, 1998, 6th Edition, sutrasthana Doshadhatumalavriddhikshaya vijnaneeya adhaya 15/37 pgno 128.

7) Sri Madhavakara, Madhukosha sanskrit commentary by Vijaya rakshita and Srikantha datta, edited by Bhramananda Tripathi, hindi commentary Chaukambha publications vol 2 Medoroganidana 34th chap pg no 34. pgno 26.

8) Vagbhata, Ashtanga hrudhaya, Acharya Brahmanand Tripathi,Hindi commentary, Chaukhamba publications, sutrasthana 14th Dividhoupakramaniya adhyaya 14/21-24 pg no 194.

9) Sri Bhavamishra, Bhavaprakasha samhita, edited by Bhramananda Tripathi, vidyotini hindi commentary, Chaukambha publications, sthaulya adhikara 39 th adhaya, pg no 405.

10) Shri Govindasa, edited Bhaishajaya Ratanavali, vidyotini hindi teeka, Chaukambha publications, pg no 746.

11) Sharangadhara, Sharangadhara samhita edited by Brahmananda Tripathi, Dipika, Hindi commentary, Chap 7/65, Chaukhamba publication.

12) Davidson's Principle and Practice of Medicine, 17th edition,churchil livingstone publishers. Disorders of Blood lipids and Lipoproteins. pgno 447.

13) Harrison’s principles of internal medicine, Anthony S.Fauci editors, Mc Graw hill Publication, 15th edition Volume 1, 2001: pg no 446.

14) API Text book of Medicine, 8th edition, published by The association of Physicians of India, Mumbai, Disorders of lipid metabolism,16th Chapter, Volume 2, pgno 954.

9. Signature of the Candidate:

10. Remarks of Guide:

11. Name and Designation of (In Block Letters)

11.1) Guide Dr. MYTHREY R. C.M.D. (Ayu)

ASST. PROFESSOR,

DEPT OF PG STUDIES INKAYACHIKITSA,

GOVT AYURVEDA MEDICAL COLLEGE,

MYSORE.

11.2) Signature:

11.3) Head of the Department:Dr. GAJANANA HEGDE M.D. (Ayu)

HOD OF DEPARTMENT

OF POSTGRADUATE STUDIES IN KAYACHIKITSA

GOVT.AYURVEDA MEDICAL COLLEGE,

MYSORE-570021

11.4): Signature:

11.5) Remarks of Chairman & Principal:

11.6) Signature:

1