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A Study to Evaluate the Efficacy of VL-NL-02 on Sleep Quality. | Clinical Trials | Clareo Health

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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.

NCT06056258•Vedic Lifesciences Pvt. Ltd.

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.

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Individuals aged between ≥ 18 and ≤ 50 years with a moderately active lifestyle as assessed International Physical Activity Questionnaire - Short form (IPAQ - SF)
•Individuals with mild to moderate sleeping issues as assessed by an ISI score of ≥ 8 and ≤ 21
•Individuals with a history of at least 3 episodes of sleep disturbances in the last month.
•Individuals with a Fasting Blood glucose (FBG) ≤ 125 mg/dl
•All individuals who are free from use of sleeping pills for at least 4 weeks before screening
•Individuals with normal levels of laboratory parameters: Liver profile, Lipid profile and kidney profile. \[Refer to section 3.7.3 for details on parameters included and reference ranges.\]
•Individuals with no more than once per week use of pain-relieving medications.
•Individuals with body mass index between ≥18 and ≤ 30 kg/m2.
•Typical bedtime between 9 PM and 11 PM.
•Individuals willing to abstain from digital activity 3 hours prior to the PSG analysis
+1 more criteria

Exclusion Criteria

•FBG \> 125 mg/dl
•Individuals diagnosed with hypertension.
•Individuals having a systolic blood pressure ≥140 mm Hg and diastolic blood pressure ≥ 90 mm Hg.
•Individuals diagnosed with Type I and Type II Diabetes Mellitus.
•Sleep disorder is secondary to another health problem such as restless leg syndrome, post-operative state etc.
•Individuals diagnosed with insomnia.
•Consumption of hypnotic drugs (\<3 months before inclusion)
•Individuals taking any other sleep promoting supplements and are unwilling to stop taking those supplements for the duration of the study period
•Individuals with history of sleepwalk
•Individuals who have bad dreams 2 or more times a week.
+15 more criteria

Locations (5)

BAJ RR Hospital

Dombivali, Maharashtra, India

Surya Multispeciality Hospital

Nashik, Maharashtra, India

Sparsh Hospital

Navi Mumbai, Maharashtra, India

Dhanwantari Hospital

Pune, Maharashtra, India

Arora Allergy Asthma and Chest Care Hospital

Ajmer, Rajasthan, India

Key Dates

Start Date

December 4, 2023

Primary Completion Date

April 1, 2024

Completion Date

April 1, 2024

Last Updated

January 28, 2025

Enrollment

ACTUAL participants

Conditions

Mood and Sleep Quality

Interventions

VL-NL-02

DIETARY_SUPPLEMENT

Placebo

DIETARY_SUPPLEMENT