A Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy of VL-NL-02 on Sleep and Mood.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mood and Sleep Quality
- Sponsor
- Vedic Lifesciences Pvt. Ltd.
- Enrollment
- 48
- Locations
- 5
- Primary Endpoint
- To assess the efficacy of Vl-NL-02 on sleep quality using the Insomnia Severity Index (ISI).
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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/m
- •Typical bedtime between 9 PM and 11 PM.
- •Individuals willing to abstain from digital activity 3 hours prior to the PSG analysis
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.
Outcomes
Primary Outcomes
To assess the efficacy of Vl-NL-02 on sleep quality using the Insomnia Severity Index (ISI).
Time Frame: Day 22 of intervention
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.
Secondary Outcomes
- 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 Improvement in deep sleep and Rapid eye movement (REM) sleep stages by Polysomnography(Day 0, 10 and 21 of intervention)
- To assess impact of VL-NL-02 on Levels of salivary cortisol immediately after awakening(Day 1 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 Levels of urinary melatonin(Day 1 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 Levels of serum Brain Derived Neurotrophic Factor (BDNF)(Day 1 and 22 of Intervention)
- To assess impact of VL-NL-02 on Levels of serum serotonin(Day 1 and 22 of Intervention)