To evaluate the analgesic effect of an aqueous extract of Terminalia chebula, a proprietary chromium complex, and their combination in subjects with joint discomfort.

Not Applicable

Completed

• Conditions: Health Condition 1: M179- Osteoarthritis of knee, unspecifiedHealth Condition 2: null- Subjects of either gender aged between 40 and 70 years, suffering from joint discomfort for at least 6 months duration, taking only an OTC analgesic medication occasionally.

• Registration Number: CTRI/2018/02/011692
• Lead Sponsor: izams Institute of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2014-04-28
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

Subjects of either gender aged between 40 and 70 years, suffering from joint discomfort for at least 6 months duration, taking only an OTC analgesic medication occasionally and meeting the American Rheumatism Association(ARA) functional class I to III and radiological evidence of osteoarthritis, patients who have grade II to IV of the Kellgren and Lawrence scale in the knee joint X-ray and who record baseline pain scores of at least 40 mm on the Visual Analogue Scale(VAS), monitored at baseline visit, subjects agreeing to discontinue any use of analgesics during the study.

Exclusion Criteria

Patients with severe osteoarthritis (ARA functional class IV), Patients with radiological grading - Kellgren and Lawrence scale ranging from grade 0 to grade I, patients on alternative system of medicine, any psychiatric disorder or who have been using systemic/intra-articular steroids within 12 weeks and hyaluronic acid in the last 9 months, or potential candidates for imminent joint replacement, Patients with uncontrolled hypertension or diabetes, hepatic or renal impairment, pregnant or lactating females, or with a recent trauma of the involved knee.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modified Western Ontario and McMaster Universities (mWOMAC) Index is a disease specific outcome measure for osteoarthritis. It has three subscales assessing, Pain â??A, Stiffness-B and Physical Function for Disability-C. Primary outcome is the reduction in modified WOMAC total score (A+B+C) from baseline to the end of treatment at week 12.Timepoint: week 4, week 8 and week 12.

Secondary Outcome Measures

Name	Time	Method
VAS based assessment of Pain,Disability, and Stiffness subscales. <br/ ><br>Knee Swelling Index as measured by signal joint knee circumference. <br/ ><br>Use of rescue medication in all treatment groups. <br/ ><br>Physician global assessment-characterized by 5 categories:Excellent- complete relief of symptoms;Goodâ??partial relief of symptoms;Fairâ??minimal relief of symptoms;poorâ??no relief of symptoms;very poorâ??worsening of symptomsTimepoint: week 4, week 8 and week 12.