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A Study to Evaluate the Efficacy of VL-NL-02 on Sleep Quality.

NCT06056258 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-01-28

No results posted yet for this study

Summary

The goal of this clinical trial is to study the impact of VL-NL-02 in improving sleep quality, restorative sleep complaints, quality of life, stress levels, and sleep stages.

48 participants are expected to be randomized in a ratio of 1:1 to receive either VL-NL-02 or placebo and will be assigned a unique randomization code. Each group will have at least 20 completed participants after accounting for a dropout/withdrawal rate of 17%. The intervention duration for all the study participants is 21 days.

Participants will be asked to fill multiple questionnaires to assess sleep quality and mood imbalance.

Conditions

  • Mood and Sleep Quality

Interventions

DIETARY_SUPPLEMENT

VL-NL-02

Two capsules to be taken 45±10 mins before sleep (after dinner) for 21 days

DIETARY_SUPPLEMENT

Placebo

Two capsules to be taken 45±10 mins before sleep (after dinner) for 21 days

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
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-04
Primary Completion
2024-04-01
Completion
2024-04-01

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 NCT06056258 on ClinicalTrials.gov