NCT06473246

A Study to Determine Safety, Pharmakokinetics and Efficacy of the Different Doses of VL-SE-01 in Healthy Participants.

A Randomized, Double-blind, Placebo Controlled, Parallel Study to Determine Safety, Pharmakokinetics and Efficacy of the Different Doses of VL-SE-01 in Healthy Participants.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Vedic Lifesciences Pvt. Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The present study is a randomized, placebo-controlled, parallel study. 250 participants will be screened, and considering a screening failure rate of 20%, approximately 200 participants will be randomized in a ratio of 1:1:1:1:1 to receive either different doses of VL-SE-01 or placebo and will be assigned a unique randomization code. Each group will have at least 30 participants (total 150 completers) after accounting for a dropout/withdrawal rate of 25%. The intervention duration for all the study participants is 180 days.

Conditions

• Healthy Population

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	CBD Isolate (25 mg/0.5 ml)	0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
DIETARY_SUPPLEMENT	CBD Isolate (40 mg/0.5 ml)	0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
DIETARY_SUPPLEMENT	CBD Isolate (50 mg/0.5 ml)	0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
DIETARY_SUPPLEMENT	CBD Broad Extract (50 mg/0.5 ml)	0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
DIETARY_SUPPLEMENT	Placebo	0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.

Timeline

• Start date: 2025-02-20
• Primary completion: 2026-01-05
• Completion: 2026-02-05
• First posted: 2024-06-25
• Last updated: 2025-12-30

Locations

6 sites across 1 country: India