NCT02157701

Polyherbal Capsule Formulation for Joint Health

Polyherbal Capsule Formulation for Joint Health: a Multicenter, 2-arm, Randomized, Double-blind, Placebo-controlled Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: NewChapter, Inc. · Industry
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Subjects will come to the study site at Visit 1 for screening assessments (which will occur within 14 days before the start of the run-in period) and to answer questions associated with habitual diet, exercise capacity, and level of activity. Those subjects who meet initial inclusion/exclusion criteria will undergo a run-in period of at least 7 days at home to discontinue use of all concurrent dietary supplements. Subjects will then return to the study site at Visit 2 (Baseline; Day 0) for further assessments and those meeting all inclusion/exclusion criteria will be enrolled into the study and randomly assigned to study product. Approximately 108 subjects (54 per treatment group) will be enrolled in the study. Subjects will be evaluated at Visit 3 (Day 14), Visit 4 (Day 45), Visit 5 (Day 60, phone call), and Visit 6 (Day 90). Exercise capacity (ie, 6-minute timed walk distance test) will be assessed, along with overall knee wellness and joint-related symptoms using WOMAC, PGA, Knee Pain Rating Scale, and rescue medication usage. Safety will be assessed by collecting adverse events (AEs) and clinical laboratory data.

Conditions

• Knee Discomfort
• Pain Physical Activity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Polyherbal capsule
DIETARY_SUPPLEMENT	Placebo capsule

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2014-06-06
• Last updated: 2015-10-14

Locations

5 sites across 1 country: United States