Trials / Completed
CompletedNCT05839444
A Clinical Study to Evaluate the Safety and Tolerability of BioPB-01 in Healthy Adults
A Pilot Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Study to Evaluate the Safety and Tolerability of BioPB-01 in Healthy Adults
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 64 (actual)
- Sponsor
- Vedic Lifesciences Pvt. Ltd. · Industry
- Sex
- All
- Age
- 25 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The present study is a randomized, placebo-controlled, parallel-group, double-blind clinical study. Seventy-eight individuals will be screened, and considering a screening failure rate of 20%, approximately 64 participants will be randomized in a ratio of 1:1 to receive either BioPB-01 or Placebo
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | BioPB-01 | 2 sachets/day, one to be taken orally with (4±1 mins prior) at breakfast and one (4±1 mins prior) at dinner |
| OTHER | Placebo | 2 sachets/day, one to be taken orally with (4±1 mins prior) at breakfast and one (4±1 mins prior) at dinner |
Timeline
- Start date
- 2023-04-27
- Primary completion
- 2023-09-12
- Completion
- 2023-09-12
- First posted
- 2023-05-03
- Last updated
- 2024-02-08
Locations
2 sites across 1 country: India
Source: ClinicalTrials.gov record NCT05839444. Inclusion in this directory is not an endorsement.