Clinical Efficacy and Safety of Innovated Cream from Thai Medicinal Plants (Garcinia/Arthrinox/Bim A) Versus Diclofenac Gel in Symptomatic Treatment of Osteoarthritis of Knee

Department of Pharmacology, Faculty of Medicine, Chiang Mai University0 sites200 target enrollmentNovember 23, 2017

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Knee osteoarthritisMild to moderate knee pain
Sponsor: Department of Pharmacology, Faculty of Medicine, Chiang Mai University
Enrollment: 200
Status: Completed
Last Updated: last year

No summary available.

Registry

who.int

Start Date

November 23, 2017

End Date

September 24, 2018

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

Department of Pharmacology, Faculty of Medicine, Chiang Mai University

•a) An out\-patient, aged â‰¥ 45 years;
•b) Unilateral or bilateral knee OA according to the criteria of ACR: knee pain, radiographic osteophytes, and at least 1 of the following 3 items: age \> 50 years, morning stiffness not more than 30 minutes in duration, or crepitus on motion. The symptoms must be present for at least 3 months;
•c) VAS of knee pain between 35\-75 point (out of 100\) after stopping using their usual analgesic or NSAIDs for, at least, 7 days;
•d) Able to walk; and
•e) must sign the written consent forms to participate in the study.

•a)Underlying inflammatory arthropathy, such as rheumatoid arthritis and gout;
•b)Hyperuricemia (uric acid \> 9 mg/dL);
•c)Plan to undergo surgery in near future;
•d)Recent injury in the knee affected by OA;
•e)History of intra\-articular corticosteroid injection within the last 3 months;
•f)Hypersensitivity to NSAIDs or herbs used in this study;
•g)Use of other NSAIDs or analgesic drugs;
•h)Acute OA attack (inflammation, edema, redness, warmth);
•i)Knee joint effusion;
•j)Continuing use of symptomatic slow\-acting drugs for OA (SYSDOA) \[e.g., glucosamine sulphate, chondroitin sulphate, diacerein, and hyaluronan] for less than 4 months or stop using these drugs for less than 6 months;