RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA
COMPLETED PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
“A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF ASHWGANDHA BALA LAKSHADI TAILA AND BRIHAT BALA TAILA MATRA BASTI IN THE MANAGEMENT OF ASTHIKSHAYA W.S.R. TO OSTEOPOROSIS”
By DR. SNEHA P.G. SCHOLAR DEPARTMENT OF POST GRADUATE STUDIES IN PANCHAKARMA AYURVEDA MAHAVIDYALAYA, HUBLI - 580024
Guide DR.A.I.SANAKAL M.D (Ayu) PROFESSOR DEPARTMENT OF POST GRADUATE STUDIES IN PANCHAKARMA AYURVEDA MAHAVIDYALAYA, HUBLI – 580024
Co-Guide DR. SHRIVATSA. M. NAVALUR M.D (Ayu) LECTURER DEPARTMENT OF POST GRADUATE STUDIES IN PANCHAKARMA AYURVEDA MAHAVIDYALAYA, HUBLI - 580024
2012- 2013 AYURVEDA MAHAVIDYALAYA HUBLI From Dr. Sneha 1st P.G. Scholar Department of Post Graduate Studies in Panchakarma Ayurveda Mahavidyalaya Hubli– 580024
To, The Registrar Rajiv Gandhi University of Health Sciences, Bangalore. Through, The Head of the Department of Post Graduate Studies in Panchakarma And The Principal Ayurveda Mahavidyalaya Hubli Sub: Submission of Completed Performa for Registration of Subject for Dissertation.
Respected Sir,
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.D. (Ayu).
Title of Dissertation: “A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF ASHWGANDHA BALA LAKSHADI TAILA AND BRIHAT BALA TAILA MATRA BASTI IN THE MANAGEMENT OF ASTHIKSHAYA W.S.R. TO OSTEOPOROSIS” I am here with enclosing the completed Proforma for Registration of subject for dissertation. Thanking you, Place: Hubli Yours faithfully
Date: Dr. SNEHA RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION I. Name of the Candidate and address: DR. SNEHA (In block letters) 1s t P.G. SCHOLAR DEPARTMENT OF POST GRADUATE STUDIES IN PANCHAKARMA AYURVEDA MAHAVIDYALAYA HUBLI KARNATAKA - 580 024
Permanent address: DR. SNEHA
SHRI BANASHANKARI HP GAS AGENCY
GURMATKAL
DIST. & TQ YADGIR - 585202
II. Name of the Institution: AYURVEDA MAHAVIDYALAYA, HUBLI - 580024
III. Course of Study: DOCTOR OF MEDICINE (AYURVEDA) IN PANCHAKARMA
IV. Date of Admission of Course: 22-12-2012
V. Title of the Topic:
“A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF ASHWGANDHA BALA LAKSHADI TAILA AND BRIHAT BALA TAILA MATRA BASTI IN THE MANAGEMENT OF ASTHIKSHAYA W.S.R. TO OSTEOPOROSIS” VI. Brief resume of the intended work
6.1 Need for study:
'Ayurveda', "the science of life" is a time tested treasure of knowledge which explains human body as a congenial homeostasis of Dosha, Dhatu and Mala. The function of dhatus is dharana of the sharira. Among the dhatus, Asthi dhatu is blessed with the function of sharira dharana. It gives shape to the body and protects the vital organs. Equilibrium of dhatus is health and their disequilibrium is disease. This disequilibrium may either be increase or decrease. Asthi kshaya (decrease in bone tissue) is a condition explained in Ayurveda, under the heading of ashtadasha kshayas. According to the principles of Aashrayaashrayee bhava, Asthi dhatu is the seat of Vata dosha and Asthi & Vata are inversely proportional to each other regarding increase and decrease. Increase of Vata leads to decrease of Asthi. Here, an effort is made to critically analyse the concept of Asthi kshaya mentioned in Ayurveda with special reference to Osteoporosis. The function of asthi dhatu is dharana, support of the body, along with nourishing majja. When it is asthi kshaya (deficient) it gives rise to Asthitoda (pain in bones), danta shathana and nakha shathana,roma shathana and rukshata of the shareera. Vagbhat points out that, “Vata dosha resides in asthi dhatu”. Asthi and vayu in the bones are in an inverse relationship, so that factors that increase vata decrease Asthi dhatu. As with any dhatu, there are several factors that can lead to dhatu kshaya. If jatharagni is affected there will be lack of poshana (nutrition) to asthi dhatu, leading to asthi kshaya. If asthi dhatu agni is increased, there will be excess resumption of bone, or excess osteoclast activity, again leading to asthi kshaya. And if asthi dhatu Agni is diminished, there may be decreased bone formation or diminished activity of osteoblasts in building bone. Osteoporosis is one of the common health problems seen in day today life in the age group above 30 years. Now a day it has clinical and economic significance. It is world wide spread common condition in ageing process. Osteoporosis is a condition of low bone mass density and micro architectural disruption of Bones that results in bone fractures with minimal trauma between 30-50% of women and between 15-30% men suffer from fracture related to Osteoporosis. According to W.H.O Osteoporosis is second only to cardiovescular disease as a global health care problem & medical studies show a 50years old women has a similar life time risk of dying from hip fractures as from breast cancer. Osteoporosis is a global health problem which is increasing in significance as the population of the world both grows and ages. In India 1 out of 8 males and 1 out of 3 females suffer with Osteoporosis making India one of the largest affected countries in the world. In Ayurveda classics,descriotion of symptoms of Asthikshaya mentioned. Osteoporosis is one of the aspects of Asthikshaya in the glance of Ayurveda and not the whole one. Asthi kshaya is one of the vataja vikara. Hence Basti is the best treatment for Vata as said in Ayurvedic classics. Basti is described as the best line of treatment to cure the imbalance of the vata dosha. Simultaneously it is also true that this procedure is equally effective in rectifying the abnormal accumulation of pitta as well as kapha dosha. As the vata dosha has predominant role in pathogenesis of any disease; and this vata dosha alone is capable of mobilizing pathological accumulation of dosha from the shakha into kostha, where from it is eliminated from the body. Thus the basti treatment gains much importance in the practice of Ayurveda. The drugs combined made Pathiva Vayuviya Akashiya dravya and having Vatahara, Shoolahara, Dhatuvardhaka, Balya Agnivardhaka actions are essential to treat Asthi kshaya. In the present study it is point to undertake Ashwagandha bala lakshadi taila and Brihat bala taila since the ingredients of these formations are mainly snigdha,vatha hara,balya,asthi dhatu vardhaka,shoolahara and agnivardhaka as well. So Vasthi is a procedure aimed at treating vata dosha at the level of kostha,shakha,marma, asthi,sandhi. Considering the plight of the patient suffering with Osteoporosis and limitations of the modern science,it is planned to undertake this presence study to evaluate the efficacy of Ashwagandha Bala Lakshadi Taila & Brihat Bala Taila Matra Basti in the management of Astikshaya/Osteoporosis.
6.2 REVIEW OF LITERATURE : a. Explanation of Asthikshaya and laxana1,2,3 b. Treatment principles of Asthikshaya4,5,6 c. Explanation of Osteoporosis7,8,9 d. Explanation of Matra Basti10 e. Explanation of Ashwagandha bala lakshadi taila11 f. Explanation of Brihat bala taila12 . PREVIOUS WORK DONE:
1. 2002-A Clinical evaluation of Asthikshaya w.s.r. Osteoporosis and its management through Ksheera basthi and Tab. Calcipral by Dr.Sanjay Kadlimatti ,Ayurveda Maha vidyalaya Hubli RGUHS Bangalore. 2. 2003-A Clinical study on the efficacy of Yoga Basthi and Gandha taila in Asthi Soushirya w.s.r Osteoporosis by Dr T.K.Girija laxmi, RGUHS, Bangalore. 3. 2003-To study Efficacy of Chandana bala Lakshadi taila Matra Basthi in Asthi kshaya.by Dr,Kathawate Tilak Ayurveda Mahavidyalaya Pune. MUHS Nasik. 4. 2008-Clinical study to evaluate the effect of Madhumalini vasantha in Asthikshaya w.s.r Osteoporosis by Dr. Suresh Suban Sri DGM Ayurvedic Medical college Gadag RGUHS.Bangalore.
6.3 OBJECTIVE OF THE STUDY: a. To study Basti karma in detail. b. To study Asthikshaya & Osteoporosis in detail c. To evaluate the efficacy of Ashwagandha bala lakshadi thaila and Brihat bala taila Matra basti in Asthikshaya. d. To compare and ascertain the effect of both in Asthikshaya. e. To assess the efficacy of Basti Karma selected for the study on Dosha, Dooshya and Srotodushti lakshanas.
VII. MATERIALS AND METHODS: The present study title “A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF ASHWGANDHA BALA LAKSHADI TAILA AND BRIHAT BALA TAILA MATRA BASTI IN THE MANAGEMENT OF ASTHIKSHAYA W.S.R. TO OSTEOPOROSIS”
will be done with a. Ashwagandha bala lakshadi taila b. Brihat bala taila
7.1 Source of data: In the present study the research scholar proposes to take the subjects attending the O.P.D& I.P.D of Department of Post-Graduate studies in Panchakarma, Ayurveda MahaVidyalaya and Hospital, Hubli.
7.2 Methods of collection of data A clinical survey of the patients attending the O.P.D and I.P.D of Department of Post- Graduate studies in Panchakarma, Ayurveda MahaVidyalaya and Hospital, Hubli will be made and patients fulfilling the criteria of diagnosis as per the Performa will be selected for the study. A clinical evaluation of the patients will be done by collection of data through information obtained by History, Physical examination and Laboratory Tests. Review of Literature will be collected from the Postgraduate Library, Department of Panchakarma, Ayurveda MahaVidyalaya and Hospital, Hubli and from Authentic Research Journals, Websites, and Digital Publications etc. The drug required for the clinical study will be procured and prepared in the Department of Rasashastra and Bhaishajya Kalpana, AyurvedaMahavidyalaya and Hospital, Hubli.
Diagnostic criteria Patients will be diagnosed based on following clinical features Bone mineral density(BMD,Tscore <-2.5)with or without classical features of Asthikshaya/Osteoporosis.
Inclusion criteria: a) Subjects fulfilling Diagnostic criteria. b) Subjects between age group 30 to 65 years of either sex. c) Subjects who are fit for basti procedure. d) Pre and post menopausal women. Exclusion criteria: a) Traumatic, infective, endocrinal disorders and Secondary to other diseases. b) Patient with systemic disorders which interfere with the course of treatment. c) Patients suffering from pathological Osteoporosis neoplasm of the bone. d) Patients with the history of prolonged corticosteroid therapy. e) Patients of Osteoporosis with major fractures. f) Patients with Santarpanottara vikaras.
Parameters of the study Subjective parameters Asthi beda Sandhishula Bala kshaya Mamsa kshaya Aswapna Parvanam beda Atimanda chesta Sandhi shaithilya Objective parameters BMD Sr.Calcium Alkaline phosphate Weight Walking time
Observational Parameters of Basti: Matra Basti Assessment of Koshta of Athura Mathra Nirnaya of Basti dravya Temperature Basti dravya B.P, Pulse, Heart rate and Respiratory rate before and after administration of Basti. Time of administration of Matra basti Basti Basti Prathyagamana Kala Samyak Basti lakshana.
Study Design: - A Comparative Clinical study.
Sample size: - : 30 subjects suffering from Osteoporosis (Asthi kshaya ) fulfilling the diagnostic and inclusion criteria belonging to either sex irrespective of socio economical status and caste will be randomly selected for clinical study, excluding drop outs.
GROUP A - Ashwagandha bala laksadi taila Matra Basti
GROUP B - Brihat bala taila Matra Basti
ASSESSMENT CRITERIA :
The total effect of the therapy on different parameters will be recorded & finally the efficacy of Matra Basti will be assessed & the result will be recorded as,
a. Marked relief – Above 75% improvement b. Moderate relief – 50% - 75 % improvement c. Mild relief – 25% -50% improvement d. Un changed _ Below 25% improvement 7.3 Does the study require any investigations or intervention to be conducted on patients or other humans or animals if so please describe briefly. YES INVESTIGATIONS Blood-TC,DC,ESR,Hb%,RBS BMD Sr.Calcium level Alkaline phosphate X-ray if necessary Thyroid profile if necessary INTERVENTIONS: Group-A: Amapachana . Shunti churna for AmaPachana till the appearance of Nirama lakshana . Dose – 5gm twice a day with ushnodaka anupana before and after food. Administration of Matra Basti . Laghu Ahara Sevana-Neither too Snigdha nor too Rooksha. . Sthanika Abhyanga with Ashwagandha bala lakshadi taila . Sthanika Nadee sweda . Administration of Matra Basti with Ashwagandha bala lakshadi taila. Duration: 30days Parihara kala: 60days Group -B : Amapachana . Shunti churna for AmaPachana till the appearance of Nirama lakshana . Dose – 5gm twice a day with ushnodaka anupana before and after food. Administration of Matra Basti . Laghu Ahara Sevana-Neither too Snigdha nor too Rooksha . Sthanika Abhyanga with Brihat bala taila . Sthanika Nadee sweda . Administration of Matra Basti with Brihat bala taila. Duration: 30day Parihara kala: 60days
7.4 Has Ethical clearance been obtained from the institution in case of 7.3 YES Ethical clearance has been obtained by the ethical committee constituted by Ayurveda MahaVidyalaya Hubli and written consent will be taken from each individual patient or by an attendant if the patient is illiterate, on a printed consent form. VIII. LIST OF REFERENCES:
1) Vagbhatacharya, Astanga Hridaya, Pandit Bhishagacharya Hari Shastri, Krishna Das Academy, Varanasi, 2000 Pg No. -186. 2) Trikamji Yadvaji, Chraka Samhita with Ayurveda dipika commentary of Chakrapani Datta Varanasi, 1994. Sutrasthana-17/67-Pg No.-103. 3) Sushruta Dalhana, Nibhandasangraha, Krishnadas Academy Varanasi 1980 Sushruta Sharira sthana 15/19 Pg.NO.-69. 4) Vagbhata,Astanga Hridaya,with commentary Sarvanga Sundara of Arunadatta,edited by Pandit Hari Sadashiva Shastri paradaraka Bhishagacharya,Publisher Chaukambha Samsrikta Samsthana 2010,Page No.165 5) Agnivesha,Caraka Samhita,with commentary Ayurveda Dipika of Chakrapanidatta,edited by Acharya Vaidya Yadavji Trikamji,Krishna Das Academy Varanasi,Chaukambha Samsrikta,Page No.180 6) Dalhana,Sushruta Samhita,with commentary Nibhanda sangraha,Krishna Das Academy Varanasi 1980,Page No.70 7) Davidsons principles and practice of medicine 21st edition by Brian R Walker, page no -1121- 1126. 8) John P Belezikian etal Endocrinology and metabolism clinics of North America Osteoporosis,Sander 2004 Philadelphia,Pp323,Page No.116 9) API Textbook of Medivine,Eddited Dr.Siddharta.N.Shah,Published by the association of,Physicians of India,edition 8th,2008,Page No.226 10) Agnivesha,Caraka Samhita,with commentary Ayurveda Dipika of Chakrapanidatta,edited by Acharya Vaidya Yadavji Trikamji,Krishna Das Academy Varanasi,Chaukambha Samsrikta,Page No.915 11) Yogaratnakara,Eddited and Translated by Dr.Madham Shetty Suresh Babu,Chackambha Krishna Das Academy 2008,Vol 1,Page No.296 12) Vaidya Shri Ambika Datta Shastri Bhaisajya Ratnavali,Eddited by Bhishagratna Shri Brahmashankar Mishra,Chaukambha Samsrikta Bhawan Varanasi 2006,Vol 2,Page No.179 IX. Signature of the Candidate:
X. Remarks of the Guide:
XI. Name and Designation of 11.1 Guide: DR. A. I. SANAKAL M.D(Ayu.) PROFESSOR AND HEAD DEPARTMENT OF POST GRADUATE STUDIES IN PANCHAKARMA, AYURVEDA MAHAVIDYALAYA, HUBLI - 580 024.
11.2 Signature:
11.3 Co-Guide: DR.SHRIVATSA .M. NAVALUR M.D(Ayu.) LECTURER DEPARTMENT OF POST GRADUATE STUDIES IN PANCHAKARMA, AYURVEDA MAHAVIDYALAYA, HUBLI - 580 024.
11.4 Signature:
1.5 Head of Department: DR. A. I. SANAKAL M.D(Ayu.) PROFESSOR AND HEAD DEPARTMENT OF POST GRADUATE STUDIES IN PANCHAKARMA, AYURVEDA MAHAVIDYALAYA, HUBLI - 580 024.
11.6 Signature:
XII Remarks of the Principal:
12.1 Signature: Dr. P.G.SUBBANAGOUDA. M.D(Ayu.) PRINCIPAL AYURVEDAMAHAVIDYALAYA, HUBLI - 580 024