CTRI/2020/07/026603
Not yet recruiting
未知
A prospective, interventional, randomized, double-blind, multiple dose, parallel, placebocontrolledstudy to assess the efficacy of dietary supplement capsules of OmniActive HealthTechnologies, India, on joint health and muscle strength of subjects.
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- OmniActive Health Technologies
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male and/or female subjects aged between 35 and 75 years
- •(both limits inclusive).
- •2\. Clinical diagnosis of unilateral or bilateral knee osteoarthritis
- •for at least greater than 3 months, as presented by pain in the
- •knee at least for last 3 months.
- •3\. Subject with index knee joint pain rated \>\= 60 on a 100\-point
- •Pain\-VAS scale.
- •4\. Subject with knee osteoarthritis grade II/III (Kellgren\-
- •Lawrence classification).
- •5\. Subjects willing to be involved in regular physical activity
Exclusion Criteria
- •1\. Subjects who are pregnant, nursing, or planning a pregnancy
- •within the study participation period.
- •2\. Subjects with positive Urine Pregnancy Test at Screening
- •/Randomization Visit.
- •3\. Subjects with previous history of knee osteoarthritis for more
- •than 3 years.
- •4\. Subjects with previous history of any knee joint replacement
- •5\. Subjects with severe knee osteoarthritis in Grade 4 as per
- •Kellgren and Lawrence Scale.
- •6\. Subjects unwilling to refrain from the use of NSAIDs
Outcomes
Primary Outcomes
Not specified
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