Trials / Completed
CompletedNCT05825222
A Study to Evaluate the Efficacy of E-PR-01 on Musculoskeletal Health in Physically Active Individuals
A Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy of E-PR-01 on Musculoskeletal Health in Physically Active Individuals
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 157 (actual)
- Sponsor
- Vedic Lifesciences Pvt. Ltd. · Industry
- Sex
- All
- Age
- 40 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | E-PR-01 (Low dose) | One Capsule to be consumed twice a day |
| DIETARY_SUPPLEMENT | E-PR-01 (High Dose) | One Capsule to be consumed twice a day |
| DIETARY_SUPPLEMENT | Placebo | One Capsule to be consumed twice a day |
Timeline
- Start date
- 2023-04-28
- Primary completion
- 2024-01-17
- Completion
- 2024-01-17
- First posted
- 2023-04-24
- Last updated
- 2024-02-08
Locations
6 sites across 1 country: India
Source: ClinicalTrials.gov record NCT05825222. Inclusion in this directory is not an endorsement.