Polyherbal Capsule Formulation for Joint Health (NCT02157701) | Clinical Trial Compass
CompletedPhase 4
Polyherbal Capsule Formulation for Joint Health
United States108 participantsStarted 2014-06
Plain-language summary
This is a multicenter, randomized, double-blind, placebo-controlled, study in subjects with exercise-related knee pain/discomfort to determine the efficacy of a polyherbal capsule compared to placebo capsule in improving exercise capacity and overall parameters of joint health.
Who can participate
Age range25 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ≥ 25 and ≤ 75 years of age with history of joint discomfort in at least 1 knee following daily activities but otherwise healthy
* body mass index (BMI) ≥ 25 and ≤ 40 kg/m2
* sum of ≥ 60 mm (based on 100-mm visual analog scale \[VAS\]) on the first 2 questions (ie, "How much pain have you had when walking on a flat surface?" "How much pain have you had when going up or down stairs?") of the WOMAC (Section A; Appendix 2)
* females of child bearing potential must agree to use appropriate birth control methods during the entire study period
* agree not to initiate any new exercise or diet programs during the entire study period
* agree not to change their current diet or exercise program, or to use other dietary supplements other than the test product, during the entire study period
* understand the study procedures and sign the forms providing informed consent to participate in the study, and authorize the release of relevant protected health information of the study investigator.
Exclusion Criteria:
* use of NSAIDS during the study (however 81 mg of aspirin daily for cardioprotection is allowed)
* daily use of dietary supplements and herbal supplements beginning at the screening visit and during the study
* subjects with any history of chronic inflammatory disease, immune system disorder or auto-immune disorder including but not limited to the following: AIDS/HIV, ankylosing spondylitis, dermatomyositis, fibromyalgia, Grave's disease, Hashimoto's thyroi…