Clinical trial NCT06056258: A Study to Evaluate the Efficacy of VL-NL-02 on Sleep Quality.
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy of VL-NL-02 on Sleep and Mood.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mood and Sleep Quality
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2023-09-28
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, double-blind, placebo-controlled trial.
Primary purpose: OTHER

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.


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/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.

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.
* 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 diagnosed with chronic medical conditions - such as heart problems, Gastro-intestinal, hepatic, respiratory, psychiatric, kidney, or cardiovascular disorder (\<3 months before inclusion), and chronic pain since last 6 months.
* Recent (within 3 months before inclusion) change in lifestyle (food, sport and drug).
* 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:

  1. For men, consuming more than 4 drinks on any day or more than 14 drinks/week
  2. For women, consuming more than 3 drinks on any day or more than 7 drinks/week
* Exaggerated consumption of tea (≥500 mL per day), coffee (≥400 mL per day), or energy drink (≥250 mL per day),
* Individuals on dietary supplements
* Pregnant or lactating woman,
* Lifestyle habits which would modify the wake-sleep rhythm or which was expected to be modified during the study period (e.g., night work)
* Known allergy to mushroom.

Primary outcomes:
measure: To assess the efficacy of Vl-NL-02 on sleep quality using the Insomnia Severity Index (ISI).
timeFrame: Day 1 of intervention
measure: To assess the efficacy of Vl-NL-02 on sleep quality using the Insomnia Severity Index (ISI).
timeFrame: Day 11 of intervention
measure: To assess the efficacy of Vl-NL-02 on sleep quality using the Insomnia Severity Index (ISI).
timeFrame: Day 22 of intervention
Secondary outcomes:
measure: To assess impact of VL-NL-02 on Mood using Brief Mood Introspection Scale (BMIS)
timeFrame: Day 1, 11 and 22 of intervention
measure: To assess impact of VL-NL-02 on Dream as assessed by Dream and Sleep Emotions and Anxiety (DSEA) Questionnaire
timeFrame: Day 1, 11 and 22 of intervention
measure: To assess impact of VL-NL-02 on Restorative sleep by using Restorative Sleep Questionnaire - Weekly Version (RSQ-W) questionnaire
timeFrame: Day 1, 11 and 22 of intervention
measure: To assess impact of VL-NL-02 on Quality of life using RAND Short form (SF)-36
timeFrame: Day 1, 11 and 22 of intervention
measure: To assess impact of VL-NL-02 on Improvement in deep sleep and Rapid eye movement (REM) sleep stages by Polysomnography
timeFrame: Day 0, 10 and 21 of intervention
measure: To assess impact of VL-NL-02 on Levels of salivary cortisol immediately after awakening
timeFrame: Day 1 and 22 of Intervention
measure: To assess impact of VL-NL-02 on Levels of serum serotonin
timeFrame: Day 1 and 22 of Intervention
measure: To assess impact of VL-NL-02 on Levels of urinary melatonin
timeFrame: Day 1 and 22 of Intervention
measure: To assess impact of VL-NL-02 on Levels of serum Brain Derived Neurotrophic Factor (BDNF)
timeFrame: Day 1 and 22 of Intervention
Other outcomes:
Locations:
city: Dombivli
country: India
facility: BAJ RR Hospital
state: Maharashtra
city: Nashik
country: India
facility: Surya Multispeciality Hospital
state: Maharashtra
city: Navi Mumbai
country: India
facility: Sparsh Hospital
state: Maharashtra
city: Pune
country: India
facility: Dhanwantari Hospital
state: Maharashtra
city: Ajmer
country: India
facility: Arora Allergy Asthma and Chest Care Hospital
state: Rajasthan
Study officials:
References: