Mood and Sleep QualityNCT06056258
A Study to Evaluate the Efficacy of VL-NL-02 on Sleep Quality.
A study testing VL-NL-02 in people with Mood and Sleep Quality, run by Vedic Lifesciences Pvt. Ltd. at 5 sites in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Mood and Sleep Quality
- What is being tested?
- VL-NL-02
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 5 sitesIndia
- Study dates
- 4 Dec 2023to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.]
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Show all 25Show fewer
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
India5 sites
Arora Allergy Asthma and Chest Care Hospital
Ajmer, Rajasthan, 305001
BAJ RR Hospital
Dombivali, Maharashtra, 421203
Surya Multispeciality Hospital
Nashik, Maharashtra, 422003
Sparsh Hospital
Navi Mumbai, Maharashtra, 410206
Dhanwantari Hospital
Pune, Maharashtra, 411011
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy of VL-NL-02 on Sleep and Mood.
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
- Being tested
- VL-NL-02, Placebo
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VL-NL-02Dietary supplement
Two capsules to be taken 45±10 mins before sleep (after dinner) for 21 days
PlaceboDietary supplement
Two capsules to be taken 45±10 mins before sleep (after dinner) for 21 days
| Study group | Role | What they receive |
|---|---|---|
| VL-NL-02 | Active comparator | Two capsules to be taken 45±10 mins before sleep (after dinner) for 21 days. Receives: Dietary Supplement: VL-NL-02 |
| Placebo | Placebo comparator | Two capsules to be taken 45±10 mins before sleep (after dinner) for 21 days. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Day 22 of intervention
Secondary outcomes (9)
To assess impact of VL-NL-02 on Mood using Brief Mood Introspection Scale (BMIS)
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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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
Measured: Day 1 and 22 of Intervention
To assess impact of VL-NL-02 on Levels of serum Brain Derived Neurotrophic Factor (BDNF)
Measured: Day 1 and 22 of Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start4 Dec 2023
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood and Sleep QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double-blind, placebo-controlled trial.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056258
- Sponsor's protocol ID
- NS/230402/ZYL/SQ
- Status last verified
- Jan 2024
- First submitted
- 20 Sep 2023
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy of VL-NL-02 on Sleep and Mood.
- ClinicalTrials.gov ID
- NCT06056258
- Acronym / sponsor ID
- NS/230402/ZYL/SQ
- Conditions
- Mood and Sleep Quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- randomized, double-blind, placebo-controlled trial.
| Arm | Type | Receives |
|---|---|---|
| VL-NL-02 | Active comparator | Dietary Supplement: VL-NL-02Two capsules to be taken 45±10 mins before sleep (after dinner) for 21 days. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboTwo capsules to be taken 45±10 mins before sleep (after dinner) for 21 days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VL-NL-02Two capsules to be taken 45±10 mins before sleep (after dinner) for 21 days | Dietary supplement | VL-NL-02 |
| PlaceboTwo capsules to be taken 45±10 mins before sleep (after dinner) for 21 days | Dietary supplement | Placebo |
Primary outcome
To assess the efficacy of Vl-NL-02 on sleep quality using the Insomnia Severity Index (ISI).
Time frame: Day 1 of intervention
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.
To assess the efficacy of Vl-NL-02 on sleep quality using the Insomnia Severity Index (ISI).
Time frame: Day 11 of intervention
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.
To assess the efficacy of Vl-NL-02 on sleep quality using the Insomnia Severity Index (ISI).
Time frame: Day 22 of intervention
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.
9 secondary outcomes
To assess impact of VL-NL-02 on Mood using Brief Mood Introspection Scale (BMIS)
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
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
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
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
Time frame: Day 0, 10 and 21 of intervention
To assess impact of VL-NL-02 on Levels of salivary cortisol immediately after awakening
Time frame: Day 1 and 22 of Intervention
To assess impact of VL-NL-02 on Levels of serum serotonin
Time frame: Day 1 and 22 of Intervention
To assess impact of VL-NL-02 on Levels of urinary melatonin
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Mood and Sleep Quality
Recruiting
Pilot Trial for Health Products on Mood and Sleep Quality
Sleep Disturbance, Emotional Disturbance
RecruitingPhase 3
Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms
Depressive Disorder, Major
Recruiting
Virtual Reality-Based Hypnotherapy for Pain, Sleep, and Mood in Spinal Cord Injury
Spinal Cord Injuries (SCI), Chronic Pain
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Recruiting
Hemodynamics After Resistance Training
Perimenopause
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VL-NL-02 in people with Mood and Sleep Quality, run by Vedic Lifesciences Pvt. Ltd. at 5 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the efficacy of Vl-NL-02 on sleep quality using the Insomnia Severity Index (ISI). (time frame: Day 1 of intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.