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

NCT ID: NCT06056258

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-04
• Study Completion Date: 2024-04-01

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.

Conditions

Mood and Sleep Quality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

VL-NL-02

Two capsules to be taken 45±10 mins before sleep (after dinner) for 21 days.

Group Type: ACTIVE_COMPARATOR

VL-NL-02

Intervention Type: DIETARY_SUPPLEMENT

Two capsules to be taken 45±10 mins before sleep (after dinner) for 21 days

Placebo

Two capsules to be taken 45±10 mins before sleep (after dinner) for 21 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Two capsules to be taken 45±10 mins before sleep (after dinner) for 21 days

Interventions

VL-NL-02

Two capsules to be taken 45±10 mins before sleep (after dinner) for 21 days

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Two capsules to be taken 45±10 mins before sleep (after dinner) for 21 days

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vedic Lifesciences Pvt. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

BAJ RR Hospital

Dombivali, Maharashtra, India

Surya Multispeciality Hospital

Nashik, Maharashtra, India

Sparsh Hospital

Navi Mumbai, Maharashtra, India

Dhanwantari Hospital

Pune, Maharashtra, India

Arora Allergy Asthma and Chest Care Hospital

Ajmer, Rajasthan, India

Countries

India

Other Identifiers

NS/230402/ZYL/SQ

Identifier Type: -

Identifier Source: org_study_id