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CRD has conducted a series of controlled drug trials in Osteoarthritis and Rheumatoid arthritis. In conjunction with the Ayurvedic physicians several promising anti-arthritic formulations have been tested, several of which have been published in top class peer reviewed medical journals. These trials strictly adhere to the ICH-GCP guidelines.


Sr. No.
Project Title
Year
Duration
Sample size
Indication
1
A randomised, double blind, placebo controlled study of an Herbal Ayurvedic formulation in patients with active Rheumatoid arthritis. [abstract / request copy]
1994 16 weeks 182 RA
2
A single blind, long term clinical trial of dose related efficacy, of RA-11 (Native Indian Ayurvedic preparation) in the treatment of Rheumatoid arthritis and its effect on IL-6 and toxicity.
1995 16 weeks 100 RA
3
A randomized, double blind placebo controlled evaluation of RA-11 (Artrex), in patients with symptomatic Osteoarthritis. [abstract / request copy]
1995-1996 32 weeks 90 OA
4
A randomised, double blind, multicentric study, to document the efficacy, safety and tolerability of Meloxicam in comparison to Piroxicam in patients suffering from Rheumatoid Arthritis. [abstract / request copy]
1998 4 weeks 121 RA
5
A randomized, double blind, multicentric study, to document the Efficacy, safety and tolerability of Meloxicam in comparison to Diclofenac Sodium in patients suffering from Osteoarthritis. [abstract / request copy]
1998 4 weeks 133 OA
6

A randomized, double blind, multicentric study, to document the efficacy, safety and tolerability of Rofecoxib in comparison to Diclofenac in patients suffering from Osteoarthritis.
[abstract / request copy]

2000
4 weeks 60 OA
7
A randomized, double blind, multicentric study, to document the efficacy, safety and tolerability of Celecoxib in comparison to Piroxicam in Indian patients suffering from Rheumatoid arthritis.
1999 4 weeks 50 RA
8
A randomised, double blind, multicentric study, to compare the efficacy, safety and tolerability of Rofecoxib Betacyclodextrin with Rofecoxib in patients with Rheumatoid arthritis.
2002 4 weeks 86 RA
9
A randomized, double blind, multicentric study, to document the efficacy, safety and tolerability of Rofecoxib Betacyclodextrin in comparison to Rofecoxib in patients suffering from Osteoarthritis. [abstract / request copy]

2002

4 weeks 86 OA
10
A prospective, randomised, double blind placebo controlled phase III multicentric study to evaluate the efficacy and safety of IRA-01(Ayurvedic derived multiplant drug) in patients with Rheumatoid arthritis. [abstract / request copy]
2002-2003 24 weeks 130 RA
11
A controlled study to test the efficacy and safety profile of IRA-01(Ayurvedic derived multiplant drug) in an open label phase: A follow up of the IRA-01 randomized drug trial. [abstract / request copy]
2002-2003 24 weeks 62 RA
12
A Randomized, Double Blind, Platform based multiplant formulation, Multicentric Study To Evaluate The Efficacy And Safety Of N1 (Ayurvedic) and further compare them to Glucosamine Sulfate and placebo in patients with symptomatic Osteoarthritis of the Knees; a 7 arm multicentric study. (NMITLI Project)
2003 16 weeks 245 OA
13
A Study to evaluate the Efficacy And Safety of a proprietary multiplant Ayurvedic formulation in patients with Osteoarthritis Knees. (NMITLI Project)
2004 16 weeks 121 OA
14
A Study to evaluate B1-(an Ayurvedic formulation) for efficacy and safety and compare it to K1 – (Ayurvedic proprietary formulation) and N3 (multiplant Ayurvedic formulation) in patients with symptomatic Osteoarthritis (OA) of the Knees. (NMITLI Project)
2004 16 weeks 108 OA
15
An open label, Ayurvedic comparator controlled study to further evaluate the efficacy of N3 (a multiplant Ayurvedic formulation) in patients with Osteoarthritis Knees. (NMITLI Project)
2004 16 weeks 49 OA
16
A Randomized, Double Blind comparator controlled multicentric study to evaluate the efficacy and Safety of B1 (a single plant Ayurvedic formulation) and compare it with Ayurvedic proprietary formulation and Hydroxychloroquine sulphate in patients with active Rheumatoid Arthritis. (NMITLI Project)
2003-2004 24 weeks 126 RA
17
A crossover study to evaluate the efficacy of B1 (Single plant Ayurvedic formulation) patients with Rheumatoid Arthritis; a follow up of the randomized double blind 3 limb study of B1. (NMITLI Project)
2004-2005 24 weeks 48 RA
18
An Open label clinical study to evaluate dose searching activity of B2 (Single plant Ayurvedic formulation) and safety in patients with symptomatic Osteoarthritis of the Knees. (NMITLI Project)
2004 6 weeks 15 OA
19
A Phase III, 12 weeks, Multicentre, Double-Blind Randomized, Placebo-and Active Comparator-Controlled, Parallel Group Study to investigate the efficacy and safety of GW406381, 5 mg, 10 mg, 25 mg, and 50 mg administered orally once daily, in Adults with Rheumatoid arthritis. .
2005 - 2006 13 weeks 84 RA
20
A Randomized, double-blind, parallel group, placebo controlled, prospective, pilot study to evaluate the efficacy and safety of TNF alpha inhibitor SPHIRA in patients of active rheumatoid arthritis with inadequate response to Methotrexate.
2006-2007 24 weeks 80 RA
21
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 GI) in patients with syptomatic osteoarthritis Knees: A randomized, double blind comparison with Oral Celecoxib and Glucosamine.
2006-2007 24 weeks 440 OA
22 Efficacy and Safety of Nimesulide Extended Release Tablets in Symptomatic Treatment of Osteoarthritis Knee: A Double Blind Randomized Controlled Comparison with Placebo and Diclofenac Sustained Release Tablets 2007-2008 12 weeks 133 OA
23 A randomised, open label, four arms parallel study to evaluate the safety & efficacy of anti-CD6 monoclonal antibody (TihmAb) in combination with Methotrexate in patients with active rheumatoid arthritis 2008 24 weeks 30 RA
24 Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. 2009-2010 24 WEEKS 5 RA
25 An Open Label, Prospective Clinical Study to Evaluate The Efficacy and safety of TLPL/AY/03/2008 in Patients suffering from Osteoarthritis of the Knee(s) 2009-2010 24 WEEKS 40 OA
26 Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of 2 Doses of CP-690,550 in Patients with Active Rheumatoid Arthritis on Background Methotrexate 2009 2 YEARS 23 RA
27 Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of 2 Doses of CP-690,550 Monotherapy in Patients with Active Rheumatoid Arthritis 2009-2010 24 WEEKS 12 RA
28 An Open label,balanced randomized,Multiple –dose Two –period,Two- treatment,Two-sequence,Steady state, Crossover Comparative Bioequivalence Study of Two Formulations of Azathioprine in Adult Patients with Rheumatoid Arthritis (RA) 2009-2010 14 DAYS 20 RA
29 A Long Term,Open-Label Follow-Up Study of CP-690,550,A Moderately Selective Janus-Kinase-3 Inhibitor, For Treatment Of Rheumatoid Arthritis. 2010 5YEARS 41 RA
30 A Non Interventional Study to Understand Disease characteristics with Regards to Presenting Features, Demographics, Disease Duration, Basis of Diagnosis and Treatment Paradigms in Rheumatoid Arthritis
2011 9 months 15 RA
31 A Randomised,double-blind,placebo controlled,multicenter,two-part,dose ranging and confirmatory study with an operationally seamless design,evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy. 2012-2013 1 YEAR 8 RA
32 A Phase 3,Randomised,Double-Blind,Active Comparator Study of the efficacy and Safety of R-TPR-015(1422015) in patients with Active Rheumatoid Arthritis on a stable dose of Methotrexate. 2012-2013 58 WEEKS
24 RA
CENTER FOR RHEUMATIC DISEASES (CRD)
Hermes Doctor House, Hermes Elegance, Convent Street, Camp, Pune – 411 001, Maharashtra, India.
Tel:
020-26348529, 26345624, 26344099