RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA BANGALORE
COMPLETED PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
“A COMPARATIVE CLINICAL STUDY ON THE THERAPEUTIC EFFECT OF VIDANGADYA LAUHA AND LEKHANA VASTI IN MEDOROGA W.S.R. TO HYPERLIPIDAEMIA”
BY Dr. K .RAVIKANTH M.D (Ayu), SCHOLAR
GUIDE Dr. JONAH.S. M.D. (Ayu) ASSISTANT PROFESSOR DEPT. OF P.G STUDIES IN KAYA CHIKITSA S.D.M. COLLEGE OF AYURVEDA, UDUPI-574118
CO-GUIDE Dr.V.K.M. LAVANYA, M.D. (Ayu) LECTURER DEPT. OF P.G STUDIES IN KAYA CHIKITSA S.D.M. COLLEGE OF AYURVEDA, UDUPI-574118
2008-09 DEPT. OF P.G STUDIES IN KAYA CHIKITSA S.D.M. COLLEGE OF AYURVEDA, UDUPI-574118
1 From: Dr. K . RAVIKANTH M.D.(Ayu), SCHOLAR DEPT. OF P.G. STUDIES IN KAYACHIKITSA S.D.M. COLLEGE OF AYURVEDA, UDUPI - 574118
To, THE REGISTRAR RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BANGALORE
Through, THE PRINCIPAL S.D.M. COLLEGE OF AYURVEDA KUTHPADY, UDUPI - 574118
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 the dissertation to the Rajiv Gandhi University of Health Sciences, Karnataka, Bangalore, for the partial fulfillment of M.D.( Ayu ) in Kayachikitsa. Title of Dissertation:
“A COMPARATIVE CLINICAL STUDY ON THE THERAPEUTIC EFFECT OF VIDANGADYA LAUHA AND LEKHANA VASTI IN MEDOROGA W.S.R. TO HYPERLIPIDAEMIA” Here with, I am enclosing completed proforma for registration of subject for Dissertation. Thanking You,
Place: Udupi yours faithfully, Date:
(Dr. K. RAVIKANTH )
1) NAME OF THE CANDIDATE : Dr. K . RAVIKANTH
2 M.D(Ayu) SCHOLAR, DEPT.OF P.G.STUDIES IN KAYACHIKITSA S.D.M.COLLEGE OF AYURVEDA, KUTHPADY, UDUPI-574118
PERMANENT ADDRESS : Dr. K . RAVIKANTH 302, CRESCENT TOWERS, OPP. EENADU, SEETHAMMADHARA, VISAKHAPATNAM-530016. ANDHRA PRADESH.
2) NAME OF THE INSTITUTION: S.D.M. COLLEGE OF AYURVEDA, KUTHPADY, UDUPI-574118
3) COURSE OF STUDY AND SUBJECT : M.D (AYURVEDA) IN KAYACHIKITSA
4) DATE OF ADMISSION OF COURSE : 04- 06- 2008.
5) TITLE OF THE TOPIC STUDY :
“A COMPARATIVE CLINICAL STUDY ON THE THERAPEUTIC EFFECT OF VIDANGADYA LAUHA AND LEKHANA VASTI IN MEDOROGA W.S.R. TO HYPERLIPIDAEMIA”
6) BRIEF RESUME OF THE INTENDED WORK
3 6.1) NEED FOR THE STUDY: Hyperlipidaemia1 is the term used to denote raised serum levels of one or more of total cholesterol, low-density lipoprotein cholesterol, Tri-acetyl-glycerols, or both total cholesterol and triglyceride (Combined Hyperlipidaemia). This disease of modern era is much more prevalent in highly sophisticated, modernized world due to alternation in lifestyle with sedentary habits, overeating, stressful life, environmental factors etc. The prevalence of Hyperlipidaemia is increasing worldwide at an alarming rate in both developed and developing countries and has risk of producing various complications like Cardio Vascular Diseases, Diabetes, Obesity, Hypertension, Atherosclerosis, Cerebro-Vascular Diseases etc. Ayurveda explains Medoroga2 with different synonyms like Medasvina, Atisthoola and Sthoola and is characterized by Medo Ati Vriddhi, with its abnormal distribution in Sphik, Udara, Parsva, Stana pradesha and with added features like Atikshuda, Atipipasa, Kshudra Shwasa, Ati Sweda and Daurbalya. Hyperlipidaemia is the nearest clinical entity for Medoroga in Modern parlance. During past 20 years many research works are taken place and powerful drugs are put forth. In spite of Vigorous research works in this area, mankind is still leading miserable life with this disease. Hence there is a need to explore an effective line of management for this disorder. Ayurveda emphasizes various treatment modalities in the treatment of Medoroga that includes both Shodhana and Shamana which are of Rookshana and Apatarpana in nature. Hence, in this study, it is planned to evaluate and to compare the efficacy of Lekhana Vasti3,4 and Vidangadya Lauha5 in Medoroga w.s.r. to Hyperlipidaemia.
6.2) REVIEW OF LITERATURE Acharya Charaka explained Atisthoulya is due to the Dushti of Medovaha Srotas and can be understood as synonym of Medoroga, characterized by abnormal and unequal collection of Medo Dhatu in body is known as Medoroga. This view is supported by Madhavakara2 and Bhavamishra by describing separate chapter of Medoroga. Apart from using Medasvina, Atisthoola and sthoola words as synonyms, Madhavakara gives clear
4 picture by mentioning the Nidana2, Rupa2 of Medoroga by borrowing all the thoughts of previous authors. Sodhala, Vrindamadhava, Bhavamishra, Yogaratnakara have expressed their views about this disease .Acharya Sushrutha had explained various treatments for Medoroga among that Lekhana Vasti3,4 is one such important treatment and in Bhaishajya Ratnavali in Medoroga Chikitsa prakarana, Vidangadya lauha5 is explained.
SOME OF THE PREVIOUS STUDIES DONE: A Clinical study was conducted on 38 patients, in 3 groups. Group A administered with Panchatikta Guggulu Vati 6gms/day in 3 divided doses for 45 days shown more than 65% relief in signs & symptoms. Group B administered with Panchatikta Ghanavati 6gms/day in 3 divided doses for 45 days shown more than 45% relief in signs& symptoms. Group C were administered with 15 Lekhana Basti in duration of 30 days has shown more than 55% relief in signs& symptoms6. A Clinical study conducted on 25 patients by dividing into 2 groups. First group is administered with Triphala Shodhita Shilajatu 500mg twice/day for 30 days. Second group administered with Gomutra Shodhita Shilajatu 500mg twice/day for 30 days. In first group 87.5% shown improvement. In second group 44.44% shown improvement, 44.44% shown moderate improvement and 11.12% marked improvement7 A study was conducted by selecting 36 patients and randomly grouped into group A & B, were administered with Virechana+ Triphala Guggulu in group A & Lekhana Vasti+ Triphala Guggulu in group B. In group A, 41.66% shown moderate improvement and in group B 23.07% shown marked improvement, 53.84% shown moderate improvement and 15.38% shown minor improvement8 . A double blind study was conducted on 60 patients in 2 groups. Group A administered with Panchatikta Ghana and group B administered with Gomutra Shodita Guggulu in a dosage of 3 gms /day tid for 30 days. Group A has shown significant reduction in S.Cholesterol, Triglycerides and skin fold thickness. Group B has shown significant reduction in weight, BMI and circumference9
6.3) OBJECTIVES OF THE STUDY:
5 1. To make a analysis of Conceptual review of Medoroga and Hyperlipidaemia 2. To evaluate the efficacy of Vidangadya lauha in patients suffering from Medoroga / Hyperlipidaemia 3. To evaluate the efficacy of Lekhana Vasti and Vidangadya lauha together in patients suffering from Medoroga / Hyperlipidaemia. 4. To compare the efficacy of the above two groups suffering from Medoroga / Hyperlipidaemia. 7) MATERIALS AND METHODS : 7.1) Source of data: Minimum 40 patients diagnosed, as Medoroga/ Hyperlipidaemia will be taken for study from OPD and IPD of SDM Ayurveda Hospital, Udupi, Karnataka. 7.2) Method of collection of data: A special proforma will be prepared with all points of history taking, physical signs, symptoms of Ayurveda and lab investigations will be carried out as mentioned in Allied sciences. Accordingly, patients are selected and will be subjected to detailed clinical history and complete examinations. Selected patients are randomly placed under 2 groups so in each group minimum 20 patients will be included. Design of the study: It will be a single blind comparative clinical study with pre-test and post-test design wherein a minimum 40 patients suffering from Medoroga /Hyperlipidaemia will be selected irrespective of their gender, caste or creed. Investigations and The parameters of signs, symptoms will be scored on the basis of standard method and will be analyzed statistically. Duration of study: Administration of Vidangadya lauha with a dose of 500mg 2 tab b.i.d.for 28 days (Ksheera as Anupana) in Group A with fortnightly assessment. Administration of both Lekhana Vasti for initial 8 days and Vidangadya Lauha with a dose of 500mg 2 tab b.i.d.for 28 days(Ksheera as Anupana) in Group B with fortnightly assessment. Follow up period for 28 days with fortnightly assessment. Intervention:
6 Administration of Lekhana Vasti is in Yogavasti format - . Anuvasana Vasti – 5 in No. with Brihat Saindavadya tailam (1 ½ Pala) . Lekhana Vasti–3 in No, with the quantity of Madhyama Matra. (16 Pala)
Inclusion Criteria: 1. Patients presenting with pratyatma lakshana of Medoroga 2. The patients suffering from Obesity, HT, NIDDM and Hypothyroidism. 3. Patients of raised lipid profile a. S. Cholesterol (201mg/dl or more) b. S. Triglycerides (151 mg/dl or more) c. S. LDL (131 mg/dl or more) d. S. VLDL (41 mg/dl or more) 4. Patients between the ages of 16 to 60 years. 5. Patients indicated for Vasti therapy Exclusion Criteria: 1. The patient having age less than 16 and above 60 years. 2. Patient having cardiac problem. 3. Patients having major illnesses, IDDM. 4. Hyperlipidaemia due to drugs e.g. Glucocorticoids, Diuretics. Assessment Criteria: Subjective Parameters: 1. Lakshanas of Medoroga will be assessed after scoring. Objective Parameters: 1. Lipid profile values 2. Anthropometrics features (Measuring skin fold thickness by using slide calipers.) a. Skin fold of the middle portion of the Biceps muscle. b. Skin fold of the middle portion of the Triceps muscle. c. Skin fold of the middle portion of the Sub scapular region. d. Skin fold of the middle portion of the Abdomen e. Skin fold of the middle portion of the thigh region. 3. Girth circumference measurements in the areas of
7 a. Chest - In normal condition at the nipple region b. Abdomen - At the level of umbilicus. c. Pelvis - At the level of anterior superior iliac spine. d. Hip - At the level of highest point of distention of buttock. e. Mid arm - Mid of arm between shoulder and elbow joint. f. Mid thigh - Mid of thigh between Hip and knee joint g. Mid calf - Mid of the calf between knee and ankle joint. 4. Body Mass Index
7.3) Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so please describe briefly: No animal experiments will be done.
Investigations: 1. Routine Hematological and Urological examination 2. Biochemical tests (Blood sugar level and Lipid Profile). 3. ECG(If necessary)
7.4) Has ethical clearance been obtained from your institution in case of 7.3? Yes, concurrence certificate of ethical committee from the institution obtained.
8) List of References:
8 1. Kasper D L, Braunwald E, Fauci A S, Hauser S L, Longo D L, Jameson J L, et al,
editors Harrison’s Principles of Internal Medicine, volume II, 16th edition , Newyork, 2005, Mc Graw- Hill Medical Publishing Division , Pp.2607, Page No. 2288-2295.
2. Madhavakara, Madhava Nidana, Madhukosha commentary of Vijayarakshita &
Srikantadatta, edited by Yadavji Trikamji Acharya, 1986, Choukhambha orientalia, Varanasi, Pp 412 , Page No-226.
3. Sushruta, Sushruta Samhita , Nibandhasangraha commentary of Dalhana Acharya ,
Edited by Yadavji Trikamji Acharya , 2003, Choukhambha Surabharati Prakasan, Varanasi, Pp 824, Page No-75.
4. Sushruta, Sushruta Samhita , Nibandhasangraha commentary of Dalhanacharya
edited by Yadavji Trikamji Acharya, 2003, Choukhambha Surabharati Prakasan, Varanasi, Pp 824, Page No-545.
5. Govindadas, Bhaisajyaratnavali ,Vidyotini commentary of Ambikadatta Shastri,
edited by Rajeshwaradatta Shastri, 2004, Choukhambha Samskrita Sansthan, Varanasi, Pp 891, P No-527.
6. Savjani Rekha.T , A Clinical Study on the management of Sthoulya by Panchatikta
and Lekhana Basti (Unpublished doctoral dissertation, IPGT& RA, GAU, Jamnagar, 2001.)
7. Jayadev.S, A Comparative pharmaceutico clinical study of Shilajatu(Triphala Shodita
& Gomutra Shodhita) and its effect on Medoroga( Unpublished doctoral dissertation, IPGT & RA, GAU, Jamnagar, 2002.)
8. Khunt Tejal, A Comparative study on the Virechana and Lekhana Vasti in the
Management of Sthoulya, (Unpublished doctoral dissertation, IPGT & RA, GAU, Jamnagar, 2005.)
9. Sapra UmeshKumar, A Clinical Study of Hyperlipidaemia & Effect of Panchatikta
ghana in its treatment- A Double Blind study. (Unpublished doctoral dissertation, IPGT&RA, GAU, Jamnagar, 2007.)
9 9) SIGNATURE OF THE CANDIDATE:
10) REMARKS OF THE GUIDE:
11) NAME AND DESIGNATION: 11.1) GUIDE : Dr. JONAH. S. MD (Ayu) ASST PROFESSOR DEPT. OF PG STUDIES IN KAYACHIKITSA S.D.M. COLLEGE OF AYURVEDA KUTHPADY, UDUPI-574118
11.2) SIGNATURE :
11.3) CO GUIDE : Dr.V.K.M. LAVANYA MD (Ayu) LECTURER DEPT. OF P.G.STUDIES IN KAYACHIKITSA S.D.M.COLLEGE OF AYURVEDA KUTHPADY, UDUPI-574118
11.4) SIGNATURE :
11.5) HEAD OF THE DEPARTMENT: Dr.G.SHRINIVASACHARYA MD (Ayu) PROFESSOR& HOD DEPT. OF PG STUDIES IN KAYACHIKITSA S.D.M. COLLEGE OF AYURVEDA KUTHPADY, UDUPI-574118
11.6) SIGNATURE :
10 12) REMARKS OF THE CHAIRMAN & PRINCIPAL :
12.1 ) SIGNATURE :
11