Rajiv Gandhi University of Health Sciences s38

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BENGALURU, KARNATAKA

COMPLETED PROFORMA FOR REGISTRATION OF SUBJECT (PANCHAKARMA) FOR DISSERTATION OF M.D.(AYURVEDA).

“A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF MATRA BASTI WITH BALA TAILAA & MATRA BASTI WITH PRASARINI TAILAA IN SANDHIGATA VATA W. S. R. TO OSTEOARTHRITIS OF KNEE JOINT”

By SHREYASI BHARDWAJ VATS st 1 Year M.D.(Ayu) Scholar, Dept. of PG studies in Panchakarma, Muniyal Institute Of Ayurveda Medical Sciences, Manipal, Karnataka.

Guide Dr. CHETANA KUMAR M.D. (Ayu) Associate Professor, Dept. of PG studies in Panchakarma, Muniyal Institute of Ayurveda Medical Sciences, Manipal-576104, Karnataka

Co-Guide Dr.GURUPRASAD SHETTY M.D. (Ayu) Lecturer, Dept. of PG studies in Panchakarma, Muniyal Institute of Ayurveda Medical Sciences, Manipal-576104, Karnataka

2012-2013

MUNIYAL INSTITUTE OF AYURVEDA MEDICAL SCIENCES MANIPAL

1 RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALURU, KARNATAKA . ANNEXURE –II PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1) Name of the Candidate: SHREYASI BHARDWAJ VATS MD SCHOLAR, DEPARTMENT OF POST GRADUATE- STUDIES IN PANCHAKARMA, MUNIYAL INSTITUTE OF- AYURVEDA MEDICAL SCIENCES, MANIPAL: 576104.

Permanent address: SHREYASI BHARDWAJ VATS W/O Dr. ANURAG VATS, 28, OLD ARJUN NAGAR, LANE No. 3, DELHI: 110051.

2) Name of the Institution: MUNIYAL INSTITUTE OF- AYURVEDA MEDICAL SCIENCES, MANIPAL 576104

3) Course of study & subject: M.D. (AYU) IN PANCHAKARMA

4) Date of admission of course: 31-10-2012

5) Title of the topic: “A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF MATRA BASTI WITH BALA TAILAA & MATRA BASTI WITH PRASARINI TAILAA IN SANDHIGATA VATA W. S. R. TO OSTEOARTHRITIS OF KNEE JOINT”

2 6) BRIEF RESUME OF INTENDED WORK: 6.1 Need for the study: Being an eternal science, Ayurveda – The science of life, deals with Physical, Psychological as well as Spiritual well being of an individual. It covers all the spheres of human life. All human beings wish to lead a healthy life in their healthy and active body. There are several such disorders which curtails one from leading a happy, healthy and active life. Osteoarthritis is one such disorder. It is one of the most common disorder which may begin asymptomatically even in the 2nd and 3rd decades of life.1 Almost all persons by age 40 have some bodily transformation in weight bearing joints.2 It limits everyday activities such as walking, dressing, bathing etc., thus making individual handicapped. Osteoarthritis is correlated with Sandhigatavata in Ayurveda. Sandhigata Vata is described under Vatavyadhi in Samhitas and Sangraha texts. The proposed study focuses on the management Sandhigata Vata in Janu Sandhi i.e., Osteoarthritis of Knee joint. Knee joint (Janu Sandhi) is the major weight bearing joint of human body. Sandhigata Vata is a Vata disorder. Basti Chikitsa is indicated to be the best for management of Vata disorders3. According to Agnivesha, Basti is said to be half of the whole treatment4. Anuvasan basti is a type of Basti5 in which Sneha dravya is given by Basti. Matra Basti is a type of Anuvasan Basti.6 It is explained that this type of Basti can be given to almost everybody, in all the seasons & it is Nishpariharya7, i.e. is can be given with maximum ease and has no complication thereafter. Janu is a Sandi Marma, and it is explained in Charak Samhita that for the management of the diseases at Marma sthanas Vata dosa should be treated8 and since Basti is considered most effective for the management of Vata; Basti might be considered most rewarding in the treatment on Janu Sandhigata Vata. In the present study Matra Basti is employed to compare the effect of Bala Taila & Prasarini Taila in management of Janu Sandhigata Vata. Matrabasti can be administered at all times and in all seasons. It is recommended for daily use in those afflicted with Vatavikara.

6.2 Review of literature:  In Charak Samhita, Sandhigat Vata is explained to have symptoms like Vatapurna- dhrutisparsha, shotha, pain at the time of flexion and extension of joints.9  Vridha Vagabhata also explains similar sor of lakshanas in the Nidan Sthana viz:.10

3  Sushruta Samhita explains Shula & Shofa as the Laxshanas of Sandhigata Vata.11  In Yoga Ratnakar it is mentioned that Shula, shofa & Sandhi Hanti are laksanas of Sandigat Vata.12  Charaka has advised Avuvasdan in Samanya Chikitsa Sutra for the management of Vata Vyadhi.13  Basti is advised as best in the treatment of Vata disorders in Charak Samhita.14  Sushruta Acharya explains the role of sneha in the management of Sandhigata Vata.15  Vagbhat says in Astanga Hridya that when Vata dosa is causing disease in Sandhi then treatment using Sneha should be administered.16  Yogratnakar too has mentioned in the Vata Vyadhi prakarana that Sneha should be used in the management of Sandigata Vata.17  Matra basti is being motioned to have least botheration for the patient & it can be given in many of the cases regularly.18,19  Matra Basti is a type of Sneha Basti in which lesser quantity of Sneha is used. It can be given at all times without any complications20.  The amount of Sneha dravya in Matra Basti is described to be Hrsihrsvya Matra by Charak Acharya20.  Sushruta Acharya says that the Matra of Sneha dravya in Matra Basti should be 1½ Pala Sneha.21  Acharya Madhavkara, in Madhava Nidan has mentioned the symptoms of Sandhigatavata under the chapter of Vatavyadhi.  Prasarni Taila is mentioned as “Marut Aamaya Nashnam” & Bala Taila as “Shrestha Vata Vyadi Vinashanam” in Sahastrayogam and both these can be used as a Sneha for Matra Basti.22

6.3 Previous research works done on Sandhigata Vata 1. Tirumaleswar Bhatt S., A Study On Sandhigatavata And Its Management; Kayachikitsa, Ayurvedic College, Masore; RGUHS, 1989. 2. Keertan M. S., Study on the etiopathogenesis of sandhigata vata with special reference to osteoarthritis of knee joint; Roga Nidan, S. D. M. College oof Ayurveda, Udupi; RGUHS, Bangalore, 2001.

4 3. Alpesh Joshi, A clinical study on the role of Matra Basti and Shamana Yoga in the management of Sandhivata (osteoarthritis); Kayachikitsa, IPGT&R, Gujrat Ayurved University, Jamnagar 2004. 4. Mayuri Shah, A Comparative Study of Matra Basti and Some Indigenous Compound Drug in the Management of Sandhigatavata (Osteoarthritis); MD-Panchkarma thesis, IPGT&R, Gujrat Ayurved University, Jamnagar 2006. 5. Prashant D., Comparative study of Janu Basti & Janu Pichu with Murivenna in Janu Sandhigata Vata; Panchkarma, Alva’s Ayurveda Medical College & Hospital, Moodbidri, Karnataka; RGUHS, Bangalore, 2010. 6. Shridhar B., A Comparative study of Jaloukavacharana & Jatamayadi Lepa in Janusandhi shoola & shotha w.s.r.to Amavata; Panchkarma, Government Ayurvedic Medical College, Bangalore; RGUHS, Bangalore, 2010. 7. Ashish Kumar K., A Study On The Effect Of Janu-Dhara With Tila Tailaa And Kethakyadi Tailaa In Janusandhigatavata, Panchkarma; K. V. G. Ayurveda medical college & Hospital, Sullia; RGUHS, Bangalore 2010. 8. Subhasrao Biradar Surekha; To study the effect of sthanika abhyanga and steam bath in sandhigata vata w.s.r. To janu sandhi; Panchkarma, B. N. M. E. T.’s Shri Mallikarjuna Swamiji Postgraduate & Research Centre, Bijapur; RGUHS, Bangalore, 2011. 9. Chanabasappa, Pujar; Comparative study on the effect of indukanta ghrita matra basti and jalaukavacharana on janusandhigata vata; Panchkarma, Alva’s Ayurveda Medical College & Hospital, Moodbidri, Karnataka; RGUHS, Bangaloe 2011. 10. Sumit Raosaheb Patil, A comparative study of two different methods of administration of Matra Basti in Janu Sandhigata Vata, w.s.r. to Osteoarthritis of Knee joint; Panchkarma, Government Ayurvedic College, Bangalore, RGUHS, Bangalore 2011. There have been several studies done on the Role of Matra Basti in Sandigatavata or Janu Sandhigata Vata; but there has been no study in which a comparative study of Matra Basti with two different oils in Janu Sandhigata Vata (or Osteoarthritis Knee) was done. The present study will analyze the efficacy of Matra Basti in Sandhigata Vata along with the its competitive role in Janu Sandhigata Vata using Prasarini Taila & Bala Taila.

5 6.4 Objectives of the Study:

1. To study the role of Matra Basti in Sandhigata Vata w.s.r. to Osteoarthritis Knee.

2. To study the effect of Matra Basti using Prasarini Taila in Janu Sandhigata Vata.

3. To study the effect of Matra Basti using Bala Taila in Janu Sandhigata Vata.

4. To compare the effect of Matra Basti with Prasarni Taila & Bala Taila in the management of Janu Sandhigata Vata.

7.MATERIALS AND METHODS

7.1 Source of data: Patients diagnosed with Janu Sandigata Vata from the OPD and IPD of Muniyal Institute of Ayurveda Medical Sciences, Manipal will be selected for the study on the basis of Inclusion & Exclusion criteria.

7.2 Method of collection of data: In this clinical study total 40 patients (20 patients in two separate groups) will be selected on the basis of simple randomized sampling procedure according to the inclusive criteria.

7.2.1Research design: All 40 patients will be distributed in 2 equal groups: 1. Group- A: 20 Patients will be selected for treatment with Matra Basti using 60 ml of Prasarini Taila for 7 Days.

2. Group-B: 20 Patients will be selected for treatment with Matra Basti using 60 ml of Bala Taila for 7 Days Before the administration of Basti, Snehana for 30 minutes followed by Baspa Sveda for 10 minutes duration will be done on every patient. Before starting the treatment, proper counselling of the patients will be done and an informed written consent for the treatment will be obtained from all the patients included in the study.

6 7.2.2 Medicinal Oil: Prasarini Taila and Bala Taila will be obtained from the Muniyal Ayurvedic Pharmacy and the oil of same pharmacy will be used for all the patients.

INTERVENTION CHART

S.No: Procedure Oil used for Matra Basti Quantity of the Oil used

1 Matra Basti- Group A Prasarini Taila 60ml

2 Matra Basti- Group B Bala Taila 60ml

Duration of the Study: The study will be of 6 weeks duration.

Follow up: There will be three follow ups in both groups in the 6 weeks duration of study: 1. 1st Follow up: After 1 week of completion of treatment. 2. 2nd Follow up: After 3 week of completion of treatment. 3. 3rd follow up: After 5 week of completion of treatment.

Methodology: A case sheet will be prepared and the progress will be noted on the basis of assessment parameters (both subjective and objective) before treatment & at the time of every Follw-up in the case sheet.

Statistical analysis: The collected data and observations will be analyzed critically and scientifically by employing statistical tests. The statistical analysis will be done both between the groups and also within the group. Between the two groups, since the data collected is in ordinal scale, Non Parametric test shall be employed. Namely the Mann Whitney U test. For analysis within the group the method of repeated measures of ANOVA shall be used.

7 Selection criteria:- Inclusion criteria: Patients presenting with classical signs & symptoms of Janu sandigata vata (Osteoarthritis Knee joint) like: 1. Patients with Pratyatma Lakksana of Sandhigata Vata9 2. Patients’ age group 40 to 70 years irrespective of sex, religion and socioeconomic status will be taken.

3. Patients who are fit for Matra Basti and are willing to sign the informed consent will only be included in the study.

Exclusion criteria: 1. Patients having systemic disorder which might interfere with the treatment. 2. Patients who are not fit for Matra Basti 3. Patients with infective Neoplastic and traumatic condition of Knee joint

Assessment criteria: To assess the effect of therapy objectively, all the signs and symptoms will be scored depending upon their severity. Subjective parameters:  SandhiShula  Sparsha Asahyata

 Akunchana Prasaranayoh Vedana

 Gaurava

Objective parameters:  Sandhigraha (Stambha)

 Sandhisphutana (Crepitus)

 Sandhishotha

Clinical Assessment table as per Standard Symptom Scoring:1

Sandhishula No pain - 0

8 Mild pain - 1 Moderate pain but no difficulty in walking - 2 Slight difficulty in walking due to pain - 3 Severe difficulty in walking - 4

Sandhigraha (Stambha) No Stiffness - 0 Mild Stiffness - 1 Moderate Stiffness - 2 Severe difficulty due to Stiffness - 3 Severe Stiffness more than 15 minutes - 4

Akunchana Prasaranayoh Vedana No pain - 0 Pain without winching of face - 1 Pain with winching of face - 2 Prevent complete flexion - 3 Does not allow passive movement - 4

Sparsha Asahyata No tenderness - 0 Patient says tenderness - 1 Wincing of face on touch - 2 Does not allow to touch the joint - 3

Sandhisphutana No Crepitus - 0 Palpable Crepitus - 1 Audible Crepitus - 2

9 Sandhishotha No Swelling - 0 Slight Swelling - 1 Moderate Swelling - 2 Severe Swelling - 3

Total Effect of Therapy Complete Remission ≥ 75% Marked Improvement ≥ 50% Moderate Improvement ≥ 25% No Improvement = 0%

7.3 Does the study requires any investigation or any intervention to be conducted on patient or other human or animals: This study will be conducted clinically. No animal experimentation will be carried out.

Laboratory Investigations: Complete Blood Count, ESR, Blood sugar, C reactive Protein & X-ray Knee joints.24

7.4 Has ethical clearance been obtained from your institution? Yes. Concurrence has been obtained from the ethical committee.

8. References: 1. Arthritis Ireland (2009) ‘Facts about Arthritis’ accessed at http://www.arthritisireland.ie/info/facts.php January 2010 2. Pub.Med. library of E.Journals. 3. Agnivesh, Charak Samhita; Pandit Kashi nath Shasty & Dr. Gorakhnath Charurvedi, Vol-I, 25th Edition, Reprint 1995; Chaukhamba Bharati Academy, Varanasi; Pp. 1024, Pg. 468. (Ch. Su. 25/40)

10 4. Agnivesh, Charak Samhita; Pandit Kashi nath Shasty & Dr. Gorakhnath Charurvedi, Vol-II, 25th Edition, Reprint 2009; Chaukhamba Bharati Academy, Varanasi; Pp. 1208, Pg. 971. (Ch. Si. 1/39) 5. Agnivesh, Charak Samhita; Pandit Kashi nath Shasty & Dr. Gorakhnath Charurvedi, Vol-II, 25th Edition, Reprint 2009; Chaukhamba Bharati Academy, Varanasi; Pp. 1208, Pg. 1077. (Ch. Si. 10/8) 6. Vridha Vagbhata, Astanga Samgraham; Kaviraj Atri dev Gupt, Vol-I, Edition 1993; Krishna Das Academy, Varanasi; Pp. 408, Pg. 206. 7. Vridha Vagbhata, Astanga Samgraham; Kaviraj Atri dev Gupt, Vol-I, Edition 1993; Krishna Das Academy, Varanasi; Pp. 408, Pg. 206. (As. Sa. 28/8) 8. Agnivesh, Charak Samhita; Pandit Kashi nath Shasty & Dr. Gorakhnath Charurvedi, Vol-II, 25th Edition, Reprint 2009; Chaukhamba Bharati Academy, Varanasi; Pp. 1208, Pg.1053. (Ch. Si. 9/7) 9. Agnivesh, Charak Samhita; Pandit Kashi nath Shasty & Dr. Gorakhnath Charurvedi, Vol-II, 25th Edition, Reprint 2009; Chaukhamba Bharati Academy, Varanasi; Pp. 1208, Pg. 783. (Ch. Chi. 28/37) 10. Vridha Vagbhata, Astanga Samgraham; Kaviraj Atri dev Gupt, Vol-I, Edition 1993; Krishna Das Academy, Varanasi; Pp.408, Pg. 400. (As. Sa. Ni. 15/17) 11. Sushruta, Sushruta Samhita; Dr Ambika Dutt Shastri, Vol-I, Edition 2007, Chaukhambh Sanskrit Sansthan, Varanasi; Pp. 303, Pg. 230. (Su. Sa. Ni. 1/28) 12. Yogaratnakar, Vaidya Lakshmipati Shastry; Edition 2010, Chaukhanbha Prakashan, Varanasi; Pp.573, Pg.505 13. Agnivesh, Charak Samhita; Pandit Kashi nath Shasty & Dr. Gorakhnath Charurvedi, Vol-II, 25th Edition, Reprint 2009; Chaukhamba Bharati Academy, Varanasi; Pp. 1208, Pg.791. (Ch. Chi. 28/77) 14. Agnivesh, Charak Samhita; Pandit Kashi nath Shasty & Dr. Gorakhnath Charurvedi, Vol-I, 25th Edition, Reprint 1995; Chaukhamba Bharati Academy, Varanasi; Pp. 1024, Pg. 468. (Ch. Su. 25/40) 15. Sushruta, Sushruta Samhita; Dr Ambika Dutt Shastri, Vol-I, Edition 2007, Chaukhambh Sanskrit Sansthan, Varanasi; Pp.186, Pg. 26. (Su. Sa. Chi. 4/8) 16. Vagbhata, Astanga Hridya; Kaviraj Atri dev Gupt, 13th Edition 2000; Chaukhanbha Sanskrit Sansthan, Varanasi; Pp.616, Pg. 418. (As. Hr. Chi. 21/22) 17. Yogaratnakar, Vaidya Lakshmipati Shastry; Edition 2010, Chaukhanbha Prakashan, Varanasi; Pp.573, Pg.515

11 18. Vagbhata, Astanga Hridya; Kaviraj Atri dev Gupt, 13th Edition 2000; Chaukhanbha Sanskrit Sansthan, Varanasi; Pp.616, Pg. 125. (As. Hr. Su. 19/68-69) 19. Vridha Vagbhata, Astanga Samgraham; Kaviraj Atri dev Gupt, Vol-I, Edition 1993; Krishna Das Academy, Varanasi; Pp. 408, Pg. 206. 20. Agnivesh, Charak Samhita; Pandit Kashi nath Shasty & Dr. Gorakhnath Charurvedi, Vol-II, 25th Edition, Reprint 2009; Chaukhamba Bharati Academy, Varanasi; Pp. 1208, Pg. 1013. (Ch. Si. 4/53) 21. Sushruta, Sushruta Samhita; Dr Ambika Dutt Shastri, Vol-I, Edition 2007, Chaukhambh Sanskrit Sansthan, Varanasi; Pp.186, Pg.154. (Su. Ch. 35/18) 22. Sahastrayogam, Dr. R. Nisteshwar; IInd Edition, 2008, Chaukhanbha Sanskrit Series, Varanasi; Pp.540, Pg.152. (Taila Prakarana)