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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
48
BAJ RR Hospital
Dombivali, Maharashtra, India
Surya Multispeciality Hospital
Nashik, Maharashtra, India
Sparsh Hospital
Navi Mumbai, Maharashtra, India
Dhanwantari Hospital
Pune, Maharashtra, India
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.
Time frame: 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.
Time frame: 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.
Time frame: Day 22 of intervention
To assess impact of VL-NL-02 on Mood using Brief Mood Introspection Scale (BMIS)
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Arora Allergy Asthma and Chest Care Hospital
Ajmer, Rajasthan, India
It is a mood scale consisting of 16 mood adjectives to which a person responds. Four sub scores can be computed from the BMIS: Pleasant-Unpleasant, Arousal-Calm, Positive-Tired and Negative-Relaxed Mood.
Time frame: 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
The DSEA questionnaire has two subscales: Sleep anxiety and Dream emotional scale.
Time frame: 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
RSQ-W is a validated scale for measuring refreshing quality of sleep. It has 9 items with answers scaled from 1 to 5. The questionnaire asks about how one felt after waking up and starting the day during the past seven days.
Time frame: Day 1, 11 and 22 of intervention
To assess impact of VL-NL-02 on Quality of life using RAND Short form (SF)-36
The SF-36 includes multi-item scales to measure the following 8 dimensions (refer 15.2 for questionnaire): PF- Physical functioning (10 items in question 3) RP- Role limitations due to physical health problems (4 items in question 4) BP- Overall body pain (questions 7 and 8) SF- Social functioning (questions 6 and 10) MH - General mental health, covering psychological distress and well-being (5 items: questions 9 b, c, d, f and h) RE- Role limitations due to emotional problems (questions 5 a, b and c) VT- Vitality, energy or fatigue (4 items: questions 9 a, e, g and i) GH- General health perceptions (5 items: questions 1 and 11 a to d)
Time frame: 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
Polysomnography refers to a systematic process used to collect physiologic parameters during sleep. Sleep stage scoring and detection of arousals for each 30-s epoch will be performed visually according to standard AASM procedures.
Time frame: Day 0, 10 and 21 of intervention
To assess impact of VL-NL-02 on Levels of salivary cortisol immediately after awakening
Normal ranges for cortisol are: Morning hours 8 10 a.m.: \< 19.1 nmol/L (\< 0.690 μg/dL) Afternoon hours 2:30-3:30 p.m.: \< 11.9 nmol/L (\< 0.430 μg/dL)
Time frame: Day 1 and 22 of Intervention
To assess impact of VL-NL-02 on Levels of serum serotonin
The normal range is 50 to 200 ng/mL (0.28 to 1.14 µmol/L) in healthy individuals
Time frame: Day 1 and 22 of Intervention
To assess impact of VL-NL-02 on Levels of urinary melatonin
The highest levels of melatonin are recorded from 3am onwards with a value of 47.35 pg/ml
Time frame: Day 1 and 22 of Intervention
To assess impact of VL-NL-02 on Levels of serum Brain Derived Neurotrophic Factor (BDNF)
Time frame: Day 1 and 22 of Intervention