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A Study to Evaluate the Efficacy of E-PR-01 on Musculoskeletal Health in Physically Active Individuals

Joint Pain Clinical Trial

Official title:
A Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy of E-PR-01 on Musculoskeletal Health in Physically Active Individuals

Clinical Trial Summary

The present study is a randomized, placebo-controlled, parallel-group, double-blind (double-dummy) clinical study. Not more than 210 individuals will be screened, and considering a screening failure rate of 18%, approximately 168 participants will be randomized in a ratio of 1:1:1 to receive E-PR-01 (LD: 200 mg/day), E-PR-01 (HD: 400 mg/day), or placebo (400 mg/day). After accounting for a dropout/withdrawal rate of 15%, each group will have at least 48 completed participants with equal numbers of participants having knee and lumbo-sacral as index joint. The intervention duration for all the study participants will be approximately 90 days.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05825222
Study type Interventional
Source Vedic Lifesciences Pvt. Ltd.
Contact
Status Completed
Phase N/A
Start date April 28, 2023
Completion date January 17, 2024
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