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

NCT06473246 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-12-30

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Vedic Lifesciences Pvt. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-20
Primary Completion
2026-01-05
Completion
2026-02-05

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06473246 on ClinicalTrials.gov