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1 Clinical Trial Details (PDF Generation Date :- Tue, 01 Jan :42:38 GMT) CTRI Number CTRI/2008/091/ [Registered on: 08/07/2008] - Last Modified On Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study Randomized, Parallel Group, Active Controlled Trial A Controlled Equivalence Trial Comparing SGPF (Ayurvedic/Herbal) to Celecoxib and Glucosamine in Symptomatic OA Knees (NMITLI) A Phase III equivalence drug trial for evaluation of efficacy and safety of SGPF C (an oral standardized herbal preparation) and SGPF C plus (with Guggul) in patients with symptomatic Osteoarthritis Knees: A randomized, double blind comparison with Oral Celecoxib and Glucosamine. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) NMITLI OA STAGE III/1 Protocol Number Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent > CSIR, GOI Type of Sponsor NIL List of Countries of Principal Investigator DR ROHINI HANDA DR G NARSIMULU Source of Monetary or Material Support CSIR Primary Sponsor Details of Site Site Phone/Fax/ ALL INDIA INSTITUTE OF MEDICAL SCIENCES CENTER FOR RHEUMATIC DISEASES, 11 HERMES ELEGANCE, 1988, CONVENT ST, CAMP NIZAM'S INSTITUTE OF MEDICAL SCIENCES ANSARI NAGAR, New Delhi DELHI,- PANJAGUTTA, Hyderabad ANDHRA PRADESH rohinihanda@hotmail.c om narsimulunims@hotmail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? AIIMS-ETHICS CRD -ETHICS NIMS-ETHICS Status Not Applicable Health Type Date No Date Specified Condition SYMPTOMATIC OSTEOARTHRITIS KNEES Type Details Intervention SGPF'C'(AYURVEDIC) 2 CAPSULES THRICE DAILY AFTER MEALS,FOR 24 WEEKS Intervention SGPF(AYURVEDIC) 2 CAPSULES THRICE DAILY AFTER MEALS, FOR 24 WEEKS Comparator Agent CELECOXIB & GLUCOSAMINE (1) Oral Celecoxib- 200 mg in 3 page 2 / 5

3 Inclusion Criteria Exclusion Criteria Method of Generating Age From Age To Gender Details Details Permuted block randomization, fixed Inclusion Criteria divided doses for 24 weeks (2) Glucosamine sulphate:2 gm, in 3 divided doses 1. Patients of either sex, 40 to 70 years of age. 2. Diagnosis of OA knees, based on typical history, clinical presentation, classical radiological findings and fulfilling the ACR classification criteria for OA knees 3 Presence of typical osteophytes on skiagram knee is mandatory 4. A minimum pain VAS score > 4 on walking in one or both knees during the 24 hours preceding recruitment. 5. Patient ambulant and requiring treatment with an anti- inflammatory drug and not receiving regular anti inflammatory or analgesic drugs, or are not satisfied with drugs being taken and seek a change. 6. Willing to come for regular follow up visits. 7. Written Informed Consent from the patient. Exclusion Criteria 1. Known history of hypersensitivity or intolerance to NSAIDs, aspirin, COX-2 inhibitors, NSAIDs and any other analgesic medicine. 2. Pregnant women, lactating women and women of child bearing potential not following adequate contraceptive measure. 3. Patients with known contraindication to Shunthi, Guduchi, Amalaki and Guggul formulation 4. Non degenerative joint diseases or other joint diseases which will interfere with the evaluation of OA. 5. Patients incapacitated or bound to wheel chair or bed and unable to carry out self care activities. 6. Treatment with intra-articular injection of corticosteroids into the knee within 3 months preceding the study. 7. Pre-existing or recent onset of demyelinating disorders or type I diabetes 8. Ongoing treatment with anticoagulants, hydantoin, lithium, steroids, methotrexate and colchicine. 9. Presence or history of active peptic ulcer in the preceding 6 months or bleeding ulcer at anytime in the past. 10. Evidence of severe renal, hepatic or hemopoietic disease or severe cardiac insufficiency as revealed by laboratory investigations or other tests. 11. Patient with congestive heart failure 12. All patients with Hypertension and IHD will be excluded. All patients with severe and/or uncontrolled Hypertension. (Appendix C) 13. Patients of IHD diagnosed as per conventional clinical and routine investigations in standard care practice will be excluded. Patients with ECG abnormalities suggestive of IHD will be excluded. 14. Clinically significant untreated hyperlipidemia in context of a Cardiovascular risk. The normal range of the site laboratory will be used to interpret the lipid values. The significance of Hyperlipidemia will be decided by the Investigator based on the associated risk factors. (Appendix D) 15. History of having received any investigational drug in preceding one month. 16. Ayurvedic formulation or any form of CAM (Complimentary Alternative Medicine) therapy in the preceding 2 months 17. Concurrent pain relieving medication such as antipyretics, analgesics, tranquilizers, hypnotics, excessive alcohol, NSAIDs, (Paracetamol & Tramadol are permitted in extreme pain, see below for details) which would interfere with pain perception. 18. Unwilling to come for regular follow-up for the entire duration of the study. 19. Non co-operative attitude of the patient. 20. Any condition (especially in particular with reference to Cardiovascular safety profile) that, in the opinion of the investigator, does not justify the patient s inclusion for the study. page 3 / 5

4 Random Sequence Method of Concealment Blinding/Masking Pre-numbered or coded identical Containers Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded Primary Outcome Outcome Timepoints i) PainVAS (Visual Analog Scale) on walking ii) WOMAC (Western Ontario Macmasters's Osteoarthritis Index for Knee-n CRD, version of questionnaire) pain component (5 questions) iii) WOMAC difficulty (17 questions) Baseline, Week 2, Week 4, Week8, Week 12, Week 16, Week 20 and Week24. Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary (1)Walk Time/ Speed of walking(seconds) (2) Patient Global assessment of disease (5 grades) (3)Physician s Global assessment of disease (5 grades) (4) Patient s Global Assessment of Tolerability (5) Physician s Global Assessment of Tolerability (6) Physician s Global assessment of response to Therapy (7) Patient s Global assessment of response to Therapy (8) Change in Status of knee arthritis as per patient s perception (9) HAQ (Stanford Health assessment questionnaire, modified CRD version) (10) WHO-QOL Bref (11) Ayurvedic variables (including Prakruti)of efficacy & safety (11)Cytokines :Reduction in blood levels of IL-1, IL-6, TNF-α, MMP-1, 3, 13, HA and Urinay CTX-II (12)Digitised X-rays Total Sample Size=440 Sample Size from = No Date Specified 12/01/2006 Years=0 Months=6 Days=0 Completed (1) Clinical variables at Baseline, Week 2, Week 4, Week8, Week 12, Week 16, Week 20 and Week24. (2) Laboratory and Digitised X-rays at baseline and week 24 (3) Ayurvedic varaibles at all clinical endpoints The five year NMITLI arthritis project was begun in 2002 to primarily identify and validate effective and safe Ayurveda derived herbal medicines for global use in treatment of symptomatic osteoarthritis (OA) of the knees. NMITLI (New Millennium n Technology Leadership Initiative) is a program of Council of Scientific & Industrial Research, Ministry of Science and Technology, Government of, meant to identify and strengthen predetermined niche areas in science and technology for n leadership. In a step wise exploratory controlled multicentric drug trials using standardised pre-determined anti arthritic ayurvedic formulations, SGPF-C was identified with best efficacy and safety. This randomised, double blind controlled, drug trial was designed with adequate statistical power to test equivalence of efficacy of SGPF-C, alone and with a guggul extract, with oral Celecoxib and Glucosamine. Both Celecoxib and Glucosamine are widely used drugs for symptomatic treatment of OA Knees. The trial was meant to demonstrate a superior safety profile for SGPF.440 eligible patients were enrolled as per the protocol at 3 clinical centers (CRD, ; AIIMS, New Delhi;NIMS, Hyderabad) and treated for 24 weeks duration.improvement of pain and page 4 / 5

5 Powered by TCPDF ( PDF of Trial functional ability of knees was the primary outcome. Several other measures like walking time, Patient and Physician Global assessment of disease symptoms and drug tolerability, Overall quality of life were also recorded. Urinary cartilage excretory products and digitised knee joint space on X-rays were also measured using advance techniques to demonstrate the long term cartilage protective effects of the ayurvedic investigational product. In addition, the ayurvedic physician investigators evaluated the patients at every clinical endpoint to determine improvement & safety from using ayurvedic clinical methods. This project was sponsored by CSIR,GOI. page 5 / 5