NCT06056258

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

A Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy of VL-NL-02 on Sleep and Mood.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Vedic Lifesciences Pvt. Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2023-12-04
• Primary completion: 2024-04-01
• Completion: 2024-04-01
• First posted: 2023-09-28
• Last updated: 2025-01-28

Locations

5 sites across 1 country: India