NCT05052112

Cross-Over Study to Evaluate the Efficacy of E-PR-01 on Activity Induced Joint Pain

A Randomized, Placebo-controlled, Double-blind, Cross-Over Study to Evaluate the Efficacy of E-PR-01 on Activity Induced Joint Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Vedic Lifesciences Pvt. Ltd. · Industry
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This Clinical trial study for the effect of a product E-PR-01 will be studied for its ability to attain rapid pain relief in the individuals suffering from exercise-induced knee joint pain, as well as determine its sustained effect on pain reduction over a treatment period of five days.

Detailed description

The study is a randomized, double-blind, placebo controlled, cross-over study to explore the effect of a product E-PR-01 on joint pain. Approximately 50 participants aged between ≥ 20 and ≤ 60 years will be screened. At least 40 participants will be randomized, and the participants will be crossed over both the IP and placebo arms. A minimum of 32 participants must complete the study, after accounting for the screening failure and dropout /withdrawal rate of 20% each. The duration of each treatment for all the study participants will be 5 days, the washout period between each treatment period being 5 ± 2 days. The total study period from the first start of treatment visit, inclusive of the washout and treatment periods, is estimated to be 15 days.

Conditions

• Joint Pain

Interventions

Type	Name	Description
OTHER	E-PR-01	Active arm
OTHER	E- PR-02	Placebo arm

Timeline

• Start date: 2021-09-09
• Primary completion: 2021-12-15
• Completion: 2021-12-15
• First posted: 2021-09-22
• Last updated: 2023-04-06

Locations

1 site across 1 country: India