8
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
KARNATAKA, BANGALORE
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1. Name of the candidate & address: / Dr JAYAKRISHNAN.G ,S/o A.N.Gopalakrishnan Nair,
Areeppurathu House,
Bharanickavu South,
Bharanickavu Post,
Alappuzha Dist-690 541
KERALA STATE
2. Name of the Institution / A.L.N.RAO MEMORIAL AYURVEDIC MEDICAL COLLELGE & P.G CENTRE, KOPPA 577126
CHIKMAGALUR(DIST)
KARNATAKA – 577126.
3. Course of Study & Subject: / Ayurveda Vachaspathi M.D.(Ayurveda) in Kayachikitsa.
4. Date of Admission to the Course: / 1st June 2007.
5. Title of the Topic: / MANAGEMENT OF AMAVATA WITH ‘TRIVRITADI CHURNAM ’ –
A CLINICAL EVALUATION
6. Brief resume of the intended work:-
6.1 Need for the study:
Amavata is the most prevailing disease in the present era, as there is no effective and permanent solution in other systems of Medicine. As Ayurvedic Medicaments have a prominent role in relieving and curing the ailments in an effective manner, this disease is the most prone element to be approached by Ayurvedic Physicians.
In Ayurveda root cause of all diseases is ama¹. Ama resulted due to the impaired functioning of kayagni2. This ama which is eventually formed due to mandagni can cause many painful conditions wherever it gets localized along with the symptoms of the dosha associated with it, especially in the joints³.
Amavata is such a condition where vata is associated with ama and is characterized by fever, pain in the joints and inflammation and finally results in the stiffness of joints causing temporary or permanent disability of joints that hampers day to day activities⁴
Amavata is a disease existing throughout the world and afflicting all races, prevalent among 1% of the population (range between 0.3 -2.1 %) women are affected 3 times more often than men. The onset is most frequent during the fourth and fifth decade of life, with 80% of all patients developing the disease between the age of 35 and 50 5 The disease is so dreadful and that it is said to reduce the life expectancy by 5 -10 years6
In a person who inspite of having Mandagni, consumes viruddha ahara and vihara or leads with sedentary life or gets involved in physical activities immediately after a fatty and heavy meal, the vitiated vata along with the ama afflicts to the kapha sthanas, especially the sandhies leading to Amavata 7
The disease manifests with hallmark lakshanas like angamarda, aruchi, thrishna, alasya, gourava, jwaram, apaka, anganam shoonata etc8
Amavata can be closely related to Rheumatoid arthritis which is a chronic multi system disease and also the chronic form of inflammatory joint disease. It is a progressive polyarthritis with a destructive and deforming potentials9 leading to marked functional impairment 10
Since the disease is dreadful, many formulations are there in our classics, which are proven successfully. But still there are many more formulations which may be more effective in this disease.
Hence, I have planned out to find an effective, affordable and easily available drug like TRIVRITADICHURNAM is an oral administered drug. As the ingredients are easily available and seems to be efficacious, hence it is selected for study. Formulation taken from bhaishajya ratnavalli11, which is a combination of 3 drugs viz Trivrit, Saindhava lavana , Shunti, along with Aranala as anupana. This combination has been selected to test hypothesis that, it is very potent in relieving the complaints of Amavata by virechanakarma as well as for its cost effectiveness and affordability.
6.2 Review of Literature: A thorough review of classical texts and literature will be made to collect all the necessary data and information for the research work undertaken.
The compound formulation selected for the study will be screened and the modality of its preparation is selected from bhaishajya ratnavalli.
Simultaneously different contemporary medical books of modern times; journals periodicals and previous works on the disease will be screened elaborately to obtain sources of study.
The below mentioned texts will be referred and screened.
1. Astanga Sagraha : Nidana stana.
2. Astanga Hridaya: Sutra stana.
3. Susruta Samhita: Uttara stana.
4. Madhava Nidana: Amavata nidana.
5. Harrison’s Principles of Internal Medicine:Rheumatoid arthiritis.
6. Roger.C.Bone, current practice of medicine: Rheumatoid arthritis.
7. Bhava Prakasha: Amavata nidana.
8. Davidson’s Principles and Practice of medicine:Diseases of the connective tissues, Joints and Bones.
9. Bhaishajya ratnavalli:Amavata prakarana
Previous works done on amavata
1) Lakshmikantham.k- 1990
2) Laila.A.S – 1995
3) Baruah pranas-1999
4) Deepak.S.M.-2003
5) Mandal laxmeshvar -2005
6.3 Objectives of the study;
1. To evaluate the efficacy of trivritadi churnam in the management of Amavata.
2. To evaluate the merits and demerits of the trial drug.
3. To find and establish a safe, oral, lowcost and effective formulation for Amavata.
7. Materials and Methods:-
7.1 Source of data:
a) Literary source:-
A complete review of all the classical literatures; bearing the description of the disease will be made to obtain theoretical data for study. Similarly the review of literature will be made to obtain references of the formulation required for research work w.r.t. their preparation, dosage etc.
b) Pharmaceutical source:-
The formulation selected for research work,Trivritadi churnam will be prepared in the pharmacy attached to A.L.N.Rao Memorial Ayurvedic Medical Collage and Hospital; as per textual references.
c) Clinical source:- Patients of either sex diagnosed as having amavata attending the IPD and OPD of A.L.N.Rao Memorial Ayurvedic Medical Collage Hospital, Koppa and its associated hospitals will be selected for the study.
Design:-
Randomized standard single blind clinical study with pre-test and post-test design will be adopted.
7.2 Method of collection of data(Including sampling procedures):
For the present study 20 patients of either sex, falling under the age group of 15-50 years and diagnosed as having Amavata will be selected for the study from OPD & IPD of A.L.N.Rao Memorial Ayurvedic Medical College Hospital, Koppa and its associated Hospitals. The patients will be selected by purposive sampling method, strictly abiding to the inclusion and exclusion criteria. The patients thus selected are grouped into a single trial group comprising of 20 patients, following the simple random sampling method.
The Trial group will be administered with trivritadi churnam 3gm twice daily after food with aranala as anupana. Duration of treatment will be 30 days .
The general condition of patient will be thoroughly assessed through the signs and symptoms, the detailed history and physical examination finding, will be noted before the scheduled treatment and later the changes in signs and symptoms will be documented in a specially designed format.
The subjective parameters will be assessed through the classical laxanas viz Anagamarda aruchi, Trishna, Aalasya, Gourava, Jwara, Apaka, Stabdata, Sandhi Shotha, Ruk etc. similarly the assessment of objective parameters will be made with the help of R.A test, ASLO & ESR.
For the assessment of complaints, scoring will be given to all the signs and symptoms from 0-3 marks, according to the severity and will be documented properly before and after the treatment.
ASSESMENT:
Randomized, standard single blind clinical study with pre-test and post-test design will be adopted. The improvement and response of the drug will be assessed once in 15 days in the Trial group, through interrogation and observation of signs and symptoms w.r.t. both objective and subjective parameters. Statistical analysis will be done by appropriate student’s paired t’-test. The duration of the treatment will be for 30 days.
a) Inclusion Criteria
· Patients of the age group 15 yrs and 50 yrs.
· Patients diagnosed as having Amavata on the basis of classical laxanas
· Clinical features like Angamarda, Aruchi,Trishna, Aalasya, Gourava, jwara, Apaka Stabdata, Sandhi Shotha, Ruk should be present.
· Patients with <1 year of incidence will be included.
b) Exclusion Criteria
· Patients of the age group 15 yrs and50 yrs.
· Patients suffering from Sandhigata Vata, Vatarakta, Krostukashirsa, Sandhika Sannipata jwara etc.
· Patients suffering from Cardio-pulmonary diseases, Hypertension, Bleeding disorders, Diabetes etc and other serious systemic and complicated diseases.
· Congenital, Endocrine, Neurological and Auto – Immune diseases.
· Vyadhisankara
· Complications including contractures, nodules, septic arthritis etc.,
· Lactating and pregnant women.
· History of incidence >1 year
C) Treatment schedule:
Trial Group / Sample size / 20 patientsMedicine / TRIVRITADI CHURNAM
Dose / 3gm: twice daily before food
Anupana / Aranala
Duration / 30 days
Note:
· Follow up study will be undertaken for 30 days
· The dosage may vary depending on the dosha, kala, bala, vaya, kosta, agni etc of the patient.
· During the period of treatment the patients will be advised to follow strictly the pathyapathya.
d)Assessment of response:
The signs and symptoms will be recorded with an interval of 15 days in a 30 days course. The evaluation will be done on the basis of statistical analysis of the results thus obtained by using the statistical test “ appropriate paired student’s ‘t’ test”
7.3 Does the study require any investigations or interventions to be conducted on patients or other human or animal? If so, please describe briefly:
Yes, the study will be conducted on the Amavata patients only
1. Investigation:
Blood
· RA test
· ASLO
· ESR
Radiological-X-ray of afflicted joints (if needed, to rule out osteoarthritis)
2. Interventions:
Trial Group
Sample size / 20 patientsMedicine / TRIVRITADI CHURNAM
Dose / 3mg:twice daily after food
Anupana / Aranala
Duration / 30 days
7.4 Has ethical clearance been obtained from your institution in case 7.3?
Yes, ethical clearance has been obtained through the ethical committee formulated in the institution.
8. References:-
1. / Vagbhata – Astanga Sangraha, Nidanasthana, Udara Nidanam(ch12/2) English Translation by Murthy Srikantha K.R., Chaukhambha Orientalia, 1996, Varanasi, 1st Ed: vol.II : 220p.2. / Vagbhata – Astanga Hrudaya, Sutrasthana, Doshopakramaniya Adhyaya(ch13/25), English Translation by Murthy Srikantha K.R Krishnadas Academy, 1996, Varanasi, 3rd ED: vol.1:187p.
3. / Sushruta- Sushruta Samhita, Uttarasthana, Vishoochika Pratishedam Adhyaya(Ch 56/10) Ayurveda Tatva Sandeepik aCommentary by Sastri Ambikadatta, Chaukhamba Sanskrit Sansthan, 1995, Varanasi, 9th Ed: vol.II:415P
4. / Madhavakara- Madhava Nidana, Amavata Nidana(Ch 25/7,8), Madhukkosha Sanskrit commentary by Vijayarakshita and Srikantadatta with Vidyotini Hindi commentary by Sastri Sudarshana, Chaukhamba Sanskrit Sansthan, 1996, Varanasi, 26th ED: vol.1: 462 p.
5. / Fauci Anthony S et al – Harrison’s Principles of Internal Medicine, Rheumatoid Arthritis(Ch 313), The Mc .Graw Hill Cokmpanies, 1998, U.S.A., 14th Int Ed: vol.II, 1880p.
6. / Bone Roger C., Current Practice of Medicine, Rheumatology- Rheumatoid Arthritis (Ch-2) Cjurchill Livingstone, 1996, New York, 1st Ed: vol.II: Sec VI: 2.1p.
7. / Madhavakara – Madhava Nidana, Amavata Nidana (ch 25/1,2) Madhukosha Sanskrit commentary by Vijayarakshita and Srikantadatta with Vidyotini Hindi commentary by Sastri, Sudarshana, Chaukamba Sanskrit Sansthan, 1996, Varanasi, 26th Ed: : vol.i: 460p.
8. / Bhavamisra –Bhavaprakasha, Amavatadhikara (ch 26/7), Vidyotini Hindi commentary by Misra Brahmasankara, Chaukamba Sanskrit Sansthan, 1993, Varanasi, 5th Ed: 277
9. / Edwards Christopher R.W., Bouchier Ian A.D., Haslett Christopher, Chilvers Edwin Davidson’s Principles and Practice of Medicine, Diseases of the Connective tissues, Joints and Bones( Ch – 15) Churchill Livingstone, 1995, Great Britain 17th Ed: 888p
10. / Edwards Christopher R.W., Bouchier Ian A.D., Haslett Christopher’s Principles and Practice of Medicine, Diseases of the Connective tissues, Joints and Bones (Ch-15), Churchill Livingstone, 1995 Great Britain 17th Ed:892 p.
11. / Bhaishajya ratnavalli – Amavata chikitsa (29/17)vidyodini tika by kaviraj Sri Ambika Datta Shastri, Chaukamba Sanskrit Sansthan ,1997 varanasi,13thEd,435P
12. / Lakshmi kantham.K-Management of Amavata W.S.T Simhanada guggulu. (Dissertation) RGUHS 1990.
13. / Laila.A.S-Effect of shaddharana kashaya in Amavata. (Dissertation) Kerala university 1995.
14. / Baruah pranas-A clinical evaluation of effect of amrita and pippali in Amavata. (Dissertation) BHU,1999
15. / Deepak.S.M A comparative study of eranda paka and ajamodadi choornam in the management of Amavata.(Dissertation) RGUHS 2003
16. / Mandal laxmeshvar –Clinical and comparative study of nirgundi-patra svarasa and trayodashanga guggulu in the management of Amavata. (Dissertation), Jamnagar, 2005
9). Signature of the Candidate:
10). Remarks of the Guide:
11.Names and Designation of( In block letters)
11.1 Guide: / DR RASHMI REKHA MISHRA
M.D(AY) U.U PROFESSOR,
POST GRADUATE DEPT OF KAYACHIKITSA,
A.L.N.RAO MEMORIAL AYURVEDIC MEDICAL COLLELGE & P.G CENTRE, KOPPA
CHIKMAGALUR(DIST)
KARNATAKA – 577126.
11.2 Signature:
11.3 Head of the Department: / DR PRAMOD KUMAR MISHRA
M.D(AY)., (RSU).,
PROFESSOR,
POST GRADUATE DEPT OF KAYACHIKITSA,
A.L.N.RAO MEMORIAL AYURVEDIC MEDICAL COLLELGE & P.G CENTRE, KOPPA.
CHIKMAGALUR(DIST)
KARNATAKA – 577126
11.4 Signature
11.5 Remarks of Chairman & Dean
Signature.