RAJIV GANDHI UNIVERSITYOF HEALTH SCIENCES, KARNATAKA, BANGALORE
COMPLETED PROFORMA FOR REGISTRATION OF
SUBJECT FOR DISSERTATION
“A CLINICAL STUDY TO EVALUATE THE EFFECT OF AMRUTADI GUGGULU AND MANDOORA BHASMA IN SANDHIGATA VATA W.S.R TO OSTEOARTHRITIS ”
BY
DR. RAVINDER SINGH
M.D (Ayu.) SCHOLAR,
DEPARTMENT OF POST GRADUATE STUDIES IN KAYACHIKITSA
MUNIYAL INSTITUTE OF AYURVEDA MEDICAL
SCIENCES, MANIPAL
576104
GUIDE
Dr PRAMOD M .KATTI .M.D (Ayu.)
ASST. PROFESSOR DEPARTMENT OF POST GRADUATE STUDIES IN KAYACHIKITSA
MUNIYAL INSTITUTE OF AYURVEDA MEDICAL
SCIENCES, MANIPAL
576104
CO-GUIDE
Dr SHRIPATHI ACHARYA G. M.D (Ayu .), Ph.D
PROFESSOR AND HEAD OF DEPARTMENT OF POST GRADUATE STUDIES IN KAYACHIKITSA
MUNIYAL INSTITUTE OF AYURVEDA MEDICAL
SCIENCES, MANIPAL
576104
From:
Dr.Ravinder Singh.
1st year M.D (Ayu) Scholar,
Dept. of P.G. studies in Kayachikitsa,
Muniyal Institute Of Ayurveda Medical Sciences,
Manipal, Karnataka.
To:
The Registrar,
Rajiv Gandhi University of Health Sciences,
Karnataka, Bengaluru.
Through:
The Principal
Muniyal Institute Of Ayurveda Medical Sciences,
Manipal, Karnataka.
Sub: Submission of completed proforma for registration of synopsis for dissertation work in M.D. (Ayu).
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, Bengaluru, Karnataka, as partial fullfilment of M.D(Ayu) in Kayachikitsa.
TITLE OF DISSERTATION
“A CLINICAL STUDY TO EVALUATE THE EFFECT OF AMRUTADI GUGGULU AND MANDOORA BHASMA IN SANDHIGATA VATA W.S.R TO OSTEOARTHRITIS ”
I am herewith enclosing completed Performa for the registration of subject for the dissertation in M.D. (Ayu) , Thanking you,
Place: Manipal Dr. Ravinder Singh.
Date : Yours sincerely
COMPLETED PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1. NAME OF CANDIDATE:- Dr. Ravindersingh
M.D. (Ayu.) - Scholar
Department of Post Graduate Studies
InKayachikitsa
Muniyal Institute of Ayurveda Medical
Sciences, Manipal - 576104.
PERMANENT ADDRESS:- House No: 147, Vill: Ismailpur
PO: P&T Center
Dist: Saharanpur( UP) 247002
2. NAME OF INSTITUTION :- Muniyal Institute of Ayurveda
Medical Sciences, Manipal-576104.
3. COURSE OF STUDY AND SUBJECT:- M.D (Ayurveda) in KAYACHIKITSA
4.DATE OF ADMISSION OF COURSE:- 19th October 2012
5. TITLE OF TOPIC:- “A CLINICAL STUDY TO EVALUATE THE EFFECT OF AMRUTADI GUGGULU AND MANDOORA BHASMA IN SANDHIGATA VATA W.S.R TO OSTEOARTHRITIS ”
6) BRIEF RESUME OF INTENDED WORK
6.1) NEED FOR THE STUDY
Ageing is a progressive failure of the body’s homeostatic adaptive response which leads to wear and tear in the body. This physiological phenomenon produces observable changes in the structure and function of the body and increases susceptibility to a wide spectrum of diseases. Osteoarthritis is characterized by loss of joint cartilage that leads to pain and loss of function primarily in the knees and hips1. The Sandhigatavata which can be compared to osteoarthritis, is also a response of ageing process which carries degenerative changes in articular cartilage. The joint gradually loses movement with respective increase in pain and swelling of the affected joint may also be noticed2
OA is one of the leading causes of chronic disability and considered as the second largest Musculo-skeletal disorders worldwide. The symptomatic knee OA occurs in 13% of persons aged 45- 60 and over and the prevalence is expected to increase further as the population ages. Unfortunately there are less satisfactory treatments in contemporary science of medicine, mainly analgesics, anti-inflammatory are used and surgery in some cases.
Though many formulations and single drugs have been attempted by research initiatives seeking holistic management of Sandhigatavata and prevention of its complications, still there is a scope for innovative and safer treatment modalities modifying disease activity. Therefore a classical yoga namely Amrutadi Guggulu has been selected for this present study along with Mandoora Bhasma. This combination has been selected with the research hypothesis to validate its efficacy in the management of Sandhigatavata(OA) as well as its cost effectiveness and its affordability. Mandoora bhasma is taken on the basis of experience of expert physicians in Ayurveda.
6.2) REVIEW OF LITERATURE:
All the ayurvedic classical literatures including Brihatrayi, Laghutrayi and the text books related to dravyaguna vijnana will be reviewed for the study. Following will be referred for the study.
§ Charakasamhita - Chikitsasthana 28th chapter3
§ Susrutasamhita - Nidanasthana 1st chapter4
§ Ashtanga Sangraha–sutra sthana 21st chapter5
§ Ashtanga Hridaya –Chikitsasthana 21st chapter6
§ Madhavanidana-22ndchapter7
§ Bhavaprakasha - Madhyamakhandha , vatavyadhyadhikara 24th chapter8
§ Yogratnakara - Vatavyadhyadhikara , purvardha26th chapter9
§ Bhaishajyaratnavali -27th chapter10
§ Rasatantrasaar And SiddhaprayogaSangraha, Bhasma Prakaran11
§ Rasatarangini- 20thchapter12
§ Davidson’s Principles and practice of Medicine
§ Macleod’s Clinical Examination13
§ Harrison's Principles of Internal Medicine
INGREDIENTS:
1) AMRUTADI GUGGULU9,10
1. Guggulu (Balsamodendron mukul)
2. Guduchi (Tinosporacordifolia)
3. Vidanga (Embelia ribes)
4. Haritaki (Terminalia chebula)
5. Bibhitaka (Terminalia belerica)
6. Amalaki (Emblica officinalis)
7. Danti(Baliospermum montanum)
8. Shunti (Zingiber officinale)
9. Maricha (Piper Nigrum)
10. Pippali (Piper Longum)
11. Twak(Cinnamomum tamala)
12. Trivrut(Operculinat urpethum)
Guduchi is one of the most versatile rejuvenative herbs, it boosts the immunity, promote longitivity. In this formulation it enhances the action of guggulu and works well to impart additive effects. It is bitter, pungent and astringent in taste, sweet in post digestive effect and hot potency. It alleviates all the tridosas. Except pungent post digestive effect, guggulu possess the same properties as that of guduchi. Guggulu is one of the best rewarding drug for the vata diseases. The combination of both these herbs become a potent remedy for various vata disorders. Other drugs like triphala and vyosha have a reducing action on all the tissues hence they are beneficial to clear off the subtle body body channels and relieve the blockage(srotorodha) and to alleviate the vata. Vidanga also alleviates vata, so as a whole Amrutadi Guggulu is the drug in various vata disease, wherein the joints are affected.
2)MANDOORA BHASMA11,12
1. Mandoora (Red Iron Oxide)
2. Haritaki (TerminaliaChebula)
3. Bibhitaka (TerminaliaBelerica)
4. Amalaki (EmblicaOfficinalis)
5. Gomutra
Mandoora bhasma taken along with vatahara drugs provides sopha shaman in sandhigatavata . It also improves the raktavridhi, thereby speeding up the healing process in sanhigatavata disease (OA).
SOME OF THE PREVIOUS WORKS ARE
Some of the research works done on Sandhigatavata are:
1. Neetha Kumari – Evaluation of Rasnadi Guggulu in treatment of Osteoarthritis (Sandhigatavata), 1988, B.H.U.
2. Prashant vaman rao –A clinical study of effect of trayodasanga guggulu in management of sandhigata vata WSR Osteoarthritis. 2002, RGUHS
3. V S Garbyal – A clinical study on Sandhigatavata vis-à-vis Osteoarthritis and its ayurvedic management, 2002, B.H.U.
4. DK Singh – A clinical study of Snehana, Swedna and Rasnadi Guggulu in the management of Sandhigatavata, 2002, NIA, Jaipur.
5. Nagendra Mani Dwivedi - An indigenous approach to manage Janu-Sandhigatavata (OA of knee joint) by osteocare rasayana compound and knee traction, 2004, NIA, Jaipur.
6. Chacha M. L. – The Clinical study of Sandhigata Vata and special effect of Parijata Guggulu, Govt. Akhandanand Ayurvedic College, Gujarat Ayurved University, Jamnagar, 1992.
7. Sinha A. K. – Clinical effect of Shashtika Shali Pinda Sweda on SandhiVata (Osteoarthritis), Gopabandu Ayurveda Mahavidyalaya, Utkal University, Bhuvaneshwar, 1993.
8. KulkarniS. B. – Study of Upanaha Sweda in SandhigataVata, Tilak Ayurveda Mahavidyalaya, Pune University, Pune, 1994.
9. Mohite Sweta Kashinath SandhigataVata Vyadhi mein Abhadi Churna ka Prayoga EkChikitsatmaka adhyayana, Smt. K.G.M. Punarvasu, Ayurvedic College, Mumbai, Mumbai university, 2002.
10. Shah Piyush– A Comparative Study of Rasnadi Ghana Vati with and without Abyanga and Sweda in the management of SandhigataVata (Osteoarthritis), Government AkhandanandAyurvedic College, Gujarat Ayurved University, Jamnagar, 2003.
6. OBJECTIVES OF THE STUDY:
1. To study etiopathogenesis of SandhigataVata in detail in comparison to Osteoarthritis.
2. To evaluate the efficacy of Amrutadi Guggulu and Mandoora Bhasma in SandhigataVata.
3. To compare the combined efficacy of Amrutadi Guggulu and Mandoora Bhasma with Trayodosanga Gugguluon Sandhigata Vata.
7)MATERIALS AND METHODS:
7.1) SOURCE OF DATA:
CLINICAL SOURCE: Patient of either sex diagnosed as SandhigataVata will be selected for study from OPD and IPD of M.I.A.M.S Hospital, Manipal.
LITERARY SOURCE: Complete review of all classical literatures bearing description of this disease will be made to obtain theoretical data for the study.
PHARMACEUTICAL SOURCE: Formulations selected for research work Amrutadi Guggulu and Mandoora Bhasma will be prepared in pharmacy of M.I.A.M.S College Manipal as per textual referenc
7.2)METHOD OF DATA COLLECTION:
40 patients who are diagnosed as sandhigatavata according to lakshanas like sandhishoola, sputana or atopa, sopha, vatapoorna drutisparsa mentioned in classical text will be selected for drug trial and a special case proforma will be prepared which includes the details of history taking, physical signs and symptoms as mentioned in Ayurvedic classical texts, Allopathic literatures and lab investigations related to it and data will be collected along with the results for the comparison of before and after treatment. Patients data will be recorded during treatment once in 15 days and follow up will be done after 15 days of the treatment.
A. INCLUSION CRITERIA
1. Sandhigatavata diagnosed according to sign and symptoms described in Ayurvedic classics.
2. Patients of both sex within the age group of 30- 60 years
3. Patients having H/O disease more than 1 year.
4. Patients will be selected irrespective of sex, religion, occupation, habitat etc.
B. EXCLUSION CRITERIA
1. Sandhigatavata associated with other disease secondary to diabetes, IHD, CHF etc.
2. Cases which are below 30 years and above 60 years.
3. During pregnancy and lactation period.
4. Those who are under treatment with corticosteroids.
5. Patients with history of asthma, peptic ulcer and other complicated diseases.
6. Cases with H/O trauma causing arthritis.
STUDY DESIGN:
1. Patients are divided into two groups as group ‘A’ and group ‘B’ with 20 patients each.
2. Patients in group A are administered Amrutadi Guggulu and Mandoora Bhasma with ushna jala and ghrita for a duration of 30 days along with pathya ahara and vihara as below-
Group A:
Sample Size / 20 PatientsMedicine / Amrutadi Guggulu / Mandoora Bhasma
Dose / 500mg thrice a day / 250mg twice a day
Anupana / UshnaJalaq.s. / Ghrita q.s
Total Duration / 30 days / 30 days
3. Patients in group B are placed with same pathya ahara and vihara as of group A and treated as control group with standard drug Trayodosanga Guggulu as below-
Group B:
Sample Size / 20 PatientsMedicine / Trayodosanga Guggulu
Dose / 500 mg thrice aday
Anupana / Ushna Jalaq.s.
Total Duration / 30 days
4.The data obtained before the treatment and after the treatment will be analysed, using appropriate statistical methods and final conclusion is drawn.
ASSESSMENT CRITERIA:
Assessment will be done on the basis of improvement in signs and symptoms of Sandhigatavata before and after the treatment on the basis of-
SUBJECTIVE PARAMETERS
1. SandhiShoola (Joint pain).
2. Sandhishotha (Swelling)
3. Sandhigraha (Joint stiffness)
4. Sparshasayata (Joint tenderness)
5. Akunchana Prasaranjanya Vedana (Joint restriction)
6. Sandhisphutana (Crepitus)
1)SandhiShoola (Joint pain) Score:
No pain / 0Mild pain/occasional / 1
Moderate pain/frequent / 2
Severe pain/persistent / 3
2)Sandhishotha (Swelling):
No swelling / 0Slight swelling / 1
Moderate swelling / 2
Gross Swelling / 3
3)Sandhigraha (Joint stiffness)
No Stiffness / 0Stiffness up to 30 min / 1
Stiffness > 45 min / 2
4)Sparshashayata (Joint tenderness)
No tenderness / 0Pain on pressure / 1
Patient winches on pressure / 2
Pain even on touch / 3
5)AkunchanaPrasaranjanyaVedana (Joint restriction)
No Restriction / 0Partially Restricted / 1
Fully Restricted / 2
6)Sandhisphutana (Crepitus)
No crepitus / 0Palpable crepitus / 1
Audible crepitus / 2
OBJECTIVE PARAMETERS
1. Swelling
2. Crepitus
3. Range of movement
4. Tenderness
5. Temperature
6. Radiological evidences.
7. Patellar tap.
8. Circumference of knee
will be assessed on the basis of standard parameters.
INVESTIGATIONS:
1. HB,TLC,DLC,ESR
2. URINE ROUTINE
3. CBC
4. BONE DENSITY
5. RA FACTOR
6. SERUM URIC ACID
7. X-ray
8. Serum Ca+ if necessary
STATISTICAL ANALYSIS –
Unpaired t – test and ANOVA test will be used for statistical analysis
7.3) Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so please describe.
The Study will only be a human clinical study; no animal experiments will be conducted
7.4) Has ethical clearance been obtained from your institution?
Yes, Concurrence has been obtained from the Institutional ethical committee.
8) LIST OF REFERENCES
1. Davidson Stanley. Davidson’s principle and practices of medicine. 21stedn. Nicki R. Colledge, Brian R. Walker, Stuart H. Ralston. Churchil Livingstone: New York; 2010. Ch.25 p.1083-1087
2. Harrison T.R. Harrison’s Principles of Internal Medicine. 18thedn. vol 2. Anthony S.Fauci, Stephen L.Huser, Joseph Loscalzo, Dan L.Longo, J.Larry Jameson. McGraw Hill: New York;2012. p.2828-2837
3. Agnivesa. CharakaSamhita. Brahmanand Tripathi. Chaukhamba Sanskrit Pratishthan: Varansi; 2002. Chikitsasthana ch.28 p.942
4. Susrutha. SusruthaSamhita. Ambikadutta shastri. Chaukhamba Sanskrit sansthan: varansi; 2007. Nidanasthana ch.21 p.228
5. Srimad Vrddhavagbhata. AsthangaSangraha. Ravidut ttripathi. Chaukhamba Sanskrit Pratishthan: Delhi;1996. Sutrasthana ch.21 p.395
6. Vagbhata. Astanga Hrudayam. 13th edition. Atridev Gupta, Yadunandana Upadhyaya. Chaukhamba Sanskrit sansthan: varansi; 2000. Chikitsasthana ch.21 p.417
7. Madhavakara. Madhava Nidhana. GD Singhal, SN Tripathi, KR Sharma. Chaukhamba Sanskrit Pratishthan: Delhi;2008. Ch.22p. 170
8. Bhavmishra. Bhavaprakash. Bulusu Sitaram. Chaukhamba Orientalia: Varansi; 2010. Ch.24 p.295
9. Anon. Yogaratnakara. AshaKumari, Premvati tiwari. Chaukhamba visvabharti: Varansi; 2010. Ch.26 p.630-631
10. Das Govinda, Bramhashankarmishra. Bhaishajyaratnavali. Rajeshwar Dutt shastri. Chaukhamba Prakasan: Varansi; 2010. Ch. 27 p. 599
11. Anon. Rasatantrasaara and Siddhaprayoga Sangraha. 19th edn. Part-1. Krishnagopal Ayurveda Bhavan: Rajasthan; 2010. p.72-75
12. Sadanand Sharma. Rasatarangini. Kasinathshastri. Motilal Banarasi das: New Delhi;1994. Ch.20 p.517-518