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A Study to Determine Safety, Pharmakokinetics and Efficacy of the Different Doses of VL-SE-01 in Healthy Participants.
Sponsor: Vedic Lifesciences Pvt. Ltd.
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.
Official title: 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.
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2025-02-20
Completion Date
2026-02-05
Last Updated
2025-12-30
Healthy Volunteers
Yes
Conditions
Interventions
CBD Isolate (25 mg/0.5 ml)
0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
CBD Isolate (40 mg/0.5 ml)
0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
CBD Isolate (50 mg/0.5 ml)
0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
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.
Placebo
0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
Locations (6)
Shivam Hospital
Dombivali, Maharashtra, India
Dhanwantri Hospital
Pune, Maharashtra, India
Vedant Multispeciality Hospital
Pune, Maharashtra, India
Punawale Hospital
Pune, Maharashtra, India
Vishwaraj Hospital
Pune, Maharashtra, India
Shree Ashirwad Hospital
Thane, Maharashtra, India