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RECRUITING
NCT06473246
NA

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

Sponsor: Vedic Lifesciences Pvt. Ltd.

View on ClinicalTrials.gov

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

Interventions

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.

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