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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.
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Inclusion 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.
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:
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 purpose
Allocation
Interventional model
Masking
48 participants in 2 patient groups, including a placebo group
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Central trial contact
Dr. Sonali Ghosh, BAMS; Dr. Shalini Srivastava, MBBS, MD
Data sourced from clinicaltrials.gov
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