A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP CLINICAL STUDY TO EVALUATE THE ANALGESIC EFFECT OF AQUEOUS EXTRACT OF TERMINALIA CHEBULA, A PROPRIETARY CHROMIUM COMPLEX, AND THEIR COMBINATION IN SUBJECTS WITH JOINT DISCOMFORT

Abstract

Objective: To evaluate the analgesic effect of an aqueous extract of Terminalia chebula (TCE), a proprietary chromium complex (PCC), and theircombination in subjects with joint discomfort.Methods: A total of 100 patients with knee joint discomfort were randomized into five treatment groups - TCE 500 mg BID, TCE 500 mg BID+PCC400 µg OD, PCC 400 µg OD alone, placebo, and TCE 250 mg BID, for 12 weeks in a double-blinded manner. Assessment of symptoms of knee joint painand discomfort was done by modified Western Ontario and McMaster Universities Arthritis Index (mWOMAC) and knee swelling index (KSI); visualanalog scale (VAS) was used for subjective assessment of pain, stiffness, and disability. Statistical analysis was done with GraphPad Prism 6.Results: Absolute reduction in mWOMAC score in TCE 500 mg (19.82±8.35), TCE 500 mg+PCC 400 µg (13.10±5.69), PCC 400 µg (8.30±3.81), placebo(2.45±3.07), and TCE 250 mg (10.47±4.43), respectively, at the end of 12 weeks as compared to the baseline values. Absolute reduction in KSI inTCE 500 mg (28.95±16.82), TCE 500 mg+PCC 400 µg (19.14±9.50), PCC 400 µg (12.7±4.86), placebo (10.03±3.8), and TCE 250 mg (18.24±6.86),respectively, at the end of 12 weeks as compared to the baseline values (p<0.001). Similar results were seen with VAS assessments for pain, stiffness,and disability. All the treatments were well tolerated.Conclusion: TCE and PCC reduce joint discomfort.Keywords: Terminalia chebula extract, Proprietary chromium complex, Western Ontario and McMaster Universities Arthritis Index