The trial is taking place at:
J

Jivanrekha Multispeciality Hospital | Department of Clinical Research

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

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Vedic Lifesciences

Status

Enrolling

Conditions

Mood and Sleep Quality

Treatments

Dietary Supplement: Placebo
Dietary Supplement: VL-NL-02

Study type

Interventional

Funder types

Industry

Identifiers

NCT06056258
NS/230402/ZYL/SQ

Details and patient eligibility

About

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.

Enrollment

48 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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:

  • For men, consuming more than 4 drinks on any day or more than 14 drinks/week
  • 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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

48 participants in 2 patient groups, including a placebo group

VL-NL-02
Active Comparator group
Description:
Two capsules to be taken 45±10 mins before sleep (after dinner) for 21 days.
Treatment:
Dietary Supplement: VL-NL-02
Placebo
Placebo Comparator group
Description:
Two capsules to be taken 45±10 mins before sleep (after dinner) for 21 days.
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

6

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Central trial contact

Dr. Shalini Srivastava, MBBS, MD; Dr. Sonali Ghosh, BAMS

Data sourced from clinicaltrials.gov

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