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
Objective: To evaluate the analgesic effect of an aqueous extract of Terminalia chebula (TCE), a proprietary chromium complex (PCC), and their
combination 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+PCC
400 Âµg OD, PCC 400 Âµg OD alone, placebo, and TCE 250 mg BID, for 12 weeks in a double-blinded manner. Assessment of symptoms of knee joint pain
and discomfort was done by modified Western Ontario and McMaster Universities Arthritis Index (mWOMAC) and knee swelling index (KSI); visual
analog 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 (19.82Â±8.35), TCE 500 mg+PCC 400 Âµg (13.10Â±5.69), PCC 400 Âµg (8.30Â±3.81), placebo
(2.45Â±3.07), and TCE 250 mg (10.47Â±4.43), respectively, at the end of 12 weeks as compared to the baseline values. Absolute reduction in KSI in
TCE 500 mg (28.95Â±16.82), TCE 500 mg+PCC 400 Âµg (19.14Â±9.50), PCC 400 Âµg (12.7Â±4.86), placebo (10.03Â±3.8), and TCE 250 mg (18.24Â±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.
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