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

Phase 2

Completed

• Conditions: Knee osteoarthritisMild to moderate knee pain; Knee osteoarthritis; Topical drugs; Thai medicinal plants; Diclofenac gel

• Registration Number: TCTR20171123002
• Lead Sponsor: Department of Pharmacology, Faculty of Medicine, Chiang Mai University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-23
• Study Completion: 2018-09-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

a) An out-patient, aged ≥ 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.

Exclusion Criteria

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;
k)Concomitant skin disease at the application site;
l)Use of another topical product at the application site;
m)Pregnancy or lactation;
n)Malignant tumor; or
o)Clinically significant abnormalities in blood chemistry and hematology:
Hemoglobin < 9 g/dL
White blood cells < 4,000 per cu. mm.
Platelets < 100,000 per cu. mm.
Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase more than 2 times of the upper limit of normal
Estimated glomerular filtration rate < 45 mL/min per 1.73 m2 as of the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Responders at 4 weeks after starting the intervention Visual analog scale

Secondary Outcome Measures

Name	Time	Method
Knee symptoms and function at 0, 2 and 4 weeks after starting the intervention The knee injury and Osteoarthritis Outcome Score ,Stiffness at 0, 2 and 4 weeks after starting the intervention Visual analog scale,Function at 0,2 and 4 weeks after starting the intervention Time for climbing up 10 steps,Function at 0,2 and 4 weeks after starting the intervention Time up and go,Adverse events at 2 and 4 weeks after starting the intervention Non-directive questioning and diary card