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

NCT06056258 | Completed

• 1 other identifier: NS/230402/ZYL/SQ
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 5

Brief 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

Outcome Measures

Primary Outcomes (3)

• To assess the efficacy of Vl-NL-02 on sleep quality using the Insomnia Severity Index (ISI).

  The Insomnia Severity Index has seven questions that indicates insomnia without clinical significance. The scores of 0-7 determines no clinically significant insomnia, 8-14 determines sub threshold insomnia, 15-21 has moderate severity which determines clinical insomnia and lastly 22-28 has severe insomnia. For each question, participant will be asked to circle or mark the number that best correlates with their sleep quality in the past two weeks. An increase in score will determine the severity of the insomnia.

  Day 1 of intervention

• To assess the efficacy of Vl-NL-02 on sleep quality using the Insomnia Severity Index (ISI).

  The Insomnia Severity Index has seven questions that indicates insomnia without clinical significance. The scores of 0-7 determines no clinically significant insomnia, 8-14 determines sub threshold insomnia, 15-21 has moderate severity which determines clinical insomnia and lastly 22-28 has severe insomnia. For each question, participant will be asked to circle or mark the number that best correlates with their sleep quality in the past two weeks. An increase in score will determine the severity of the insomnia.

  Day 11 of intervention

• To assess the efficacy of Vl-NL-02 on sleep quality using the Insomnia Severity Index (ISI).

  The Insomnia Severity Index has seven questions that indicates insomnia without clinical significance. The scores of 0-7 determines no clinically significant insomnia, 8-14 determines sub threshold insomnia, 15-21 has moderate severity which determines clinical insomnia and lastly 22-28 has severe insomnia. For each question, participant will be asked to circle or mark the number that best correlates with their sleep quality in the past two weeks. An increase in score will determine the severity of the insomnia.

  Day 22 of intervention

Secondary Outcomes (9)

• To assess impact of VL-NL-02 on Mood using Brief Mood Introspection Scale (BMIS)

  Day 1, 11 and 22 of intervention

• To assess impact of VL-NL-02 on Dream as assessed by Dream and Sleep Emotions and Anxiety (DSEA) Questionnaire

  Day 1, 11 and 22 of intervention

• To assess impact of VL-NL-02 on Restorative sleep by using Restorative Sleep Questionnaire - Weekly Version (RSQ-W) questionnaire

  Day 1, 11 and 22 of intervention

• To assess impact of VL-NL-02 on Quality of life using RAND Short form (SF)-36

  Day 1, 11 and 22 of intervention

• To assess impact of VL-NL-02 on Improvement in deep sleep and Rapid eye movement (REM) sleep stages by Polysomnography

  Day 0, 10 and 21 of intervention

Study Arms (2)

VL-NL-02

ACTIVE COMPARATOR

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

Dietary Supplement: VL-NL-02

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

VL-NL-02 DIETARY_SUPPLEMENT

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

VL-NL-02

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Willing to maintain current dietary pattern, activity level, and stable body weight for the duration of the study, and refrain from any drastic lifestyle changes.

You may not qualify if:

• 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.
• 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.
• Individuals who are inclined to the lifestyle factors - such as jet lag, night workers and rotational shift work.
• Individuals who currently, or in the past 6 months suffered from any mental-health disorder
• Individuals who were taking psychotropic medication, herbal preparation, antidepressants, steroids, antihistamines, narcotics or any other illicit drugs in the last three months.
• Individuals who are regular smokers and/or consume any form of tobacco.
• Addiction, history of addiction, and/or substance abuse (tobacco, nicotine etc.).
• Heavy drinkers as defined by:

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (5)

BAJ RR Hospital

Dombivali, Maharashtra, 421203, India

Location

Surya Multispeciality Hospital

Nashik, Maharashtra, 422003, India

Location

Sparsh Hospital

Navi Mumbai, Maharashtra, 410206, India

Location

Dhanwantari Hospital

Pune, Maharashtra, 411011, India

Location

Arora Allergy Asthma and Chest Care Hospital

Ajmer, Rajasthan, 305001, India

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double blind
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized, double-blind, placebo-controlled trial.

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: September 28, 2023
• Study Start: December 4, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: January 28, 2025

Record last verified: 2024-01

Locations

IN (5)