Health Condition 1: null- Osteoarthritis of Knee joints.
Conditions
Interventions
Intervention1: Terminalia chebula: Terminalia chebula 500mg 1 capsule twice daily for 3 months.
Control Intervention1: Placebo: Placebo 1 capsule twice daily for 3 months.
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male & female subjects between 40-60 yrs of age and BMI more than 25. 2. A previously diagnosed case (atleast 3 months prior to screening visit) of osteoarthritis of knee as per the American college of Rhematologist clinical classification of criteria for osteoarthritis or a previously diagnosed case (atleast 3 months prior to screening visit) of osteoarthritis of shoulders. 3.Subjects should have significant arthritic pain ( screening WOMAC score between 10-40 or Visual analogue scale (VAS) >= 4 at baseline.
Exclusion criteria
Exclusion criteria: 1. Patients with rheumatoid arthritis, active gout 2. Patients with known hypersensitivity to non-steroidal anti-inflammatory or NSAIDS. 3.Patients with uncontrolled diabetes, hypertension 4.Impaired renal and hepatic function. 5.Active duodenal ulcer or acid-peptic disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To evaluate the efficacy of treatments for the reduction in pain and improvement in subjects with osteoarthritis of the knee. 2. Change in VAS and WOMAC (Western Ontario and McMaster University Osteoarthritis Index) at all study visits.Timepoint: At baseline and post treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To evaluate safety and tolerability of treatments. 2. To evaluate the changes in inflammatory markers (C-reactive protein and Malondialdehyde).Timepoint: At baseline and post treatment. | — |
Countries
India
Contacts
Public ContactDrPUsharani
Nizams Institute of Medical Sciences
Outcome results
None listed