Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05825222
Status:
COMPLETED
Last Update Posted:
2024-02-08
First Post:
2023-03-23
Brief Title:
A Study to Evaluate the Efficacy of E-PR-01 on Musculoskeletal Health in Physically Active Individuals
Sponsor:
Vedic Lifesciences Pvt Ltd
Organization:
Vedic Lifesciences Pvt Ltd
Study Overview
Official Title:
A Randomized Placebo-controlled Double-blind Study to Evaluate the Efficacy of E-PR-01 on Musculoskeletal Health in Physically Active Individuals
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 111 to receive E-PR-01 LD 200 mgday E-PR-01 HD 400 mgday or placebo 400 mgday After accounting for a dropoutwithdrawal 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None