| CTRI Number |
CTRI/2023/11/059422 [Registered on: 02/11/2023] Trial Registered Prospectively |
| Last Modified On: |
31/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to evaluate the efficacy of VL-NL-02 on sleep and mood. |
|
Scientific Title of Study
|
A randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy of VL-NL-02 on sleep and mood. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NS/230402/ZYL/SQ, Version No: 1.0, Date: Sep 13, 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shalini Srivastava |
| Designation |
Director Clinical Development |
| Affiliation |
Vedic Lifesciences Pvt. Ltd. |
| Address |
B-118, Morya House, Off New Link Road, Andheri West, Mumbai
Mumbai
MAHARASHTRA
400053
India |
| Phone |
02242172300 |
| Fax |
|
| Email |
shalini.s@vediclifesciences.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shalini Srivastava |
| Designation |
Director Clinical Development |
| Affiliation |
Vedic Lifesciences Pvt. Ltd. |
| Address |
B-118, Morya House, Off New Link Road, Andheri West, Mumbai
MAHARASHTRA
400053
India |
| Phone |
02242172300 |
| Fax |
|
| Email |
shalini.s@vediclifesciences.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonali Ghosh |
| Designation |
Project Lead |
| Affiliation |
Vedic Lifesciences Pvt. Ltd. |
| Address |
B-118, Morya House, Off New Link Road, Andheri West, Mumbai
Mumbai
MAHARASHTRA
400053
India |
| Phone |
02242172300 |
| Fax |
|
| Email |
sonali.g@vediclifesciences.com |
|
|
Source of Monetary or Material Support
|
| Vedic Lifesciences Pvt. Ltd, B-118, Morya House, Off New Link Road, Andheri West, Mumbai - 400053. |
|
|
Primary Sponsor
|
| Name |
Vedic Lifesciences Pvt. Ltd |
| Address |
B-118, Morya House, Off New Link Road, Andheri West, Mumbai - 400053. |
| Type of Sponsor |
Contract research organization |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Piyush Arora |
Arora Allergy Asthma and Chest Care Hospital |
LIC Colony, Anasagar circle road, Ajmer - 305001, Rajasthan, India
Ajmer
RAJASTHAN |
9887088122
Doctor.piyusharora@gmail.com |
| Dr Kushal Bangar |
BAJ RR Hospital |
P-14, College Road, Azde Gaon, MIDC, Dombivli East - 421203
Thane
MAHARASHTRA |
9545664884
drkushal.bangar83@gmail.com |
| Dr Bharat Jain |
Dhanwantari Hospital |
339-c, Rasta Peth, Mudaliar Road, Next to Kaka Halwai, Pune - 411011, Maharashtra, India.
Pune
MAHARASHTRA |
9860383386
dr_bharatjain@rediffmail.com |
| Dr Sayali Kusalkar |
Sparsh Hospital |
Sai Arcade, Mission Compound, Plot No. 141, Opposite Orion Mall, Line Ali, old Panvel, Panvel, Navi Mumbai, Maharashtra - 410206, India
Raigarh
MAHARASHTRA |
8850481563
nalavadesayali12@gmail.com |
| Dr Prasad Nikam |
Surya Multispeciality Hospital |
Surya Arcade, 2nd floor, Opposite Nimani Bus stand, Panchavati, Nashik, Maharashtra - 422003
Nashik
MAHARASHTRA |
9922999002
drprasadnresearch@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Galaxy Institutional Ethics Committee |
Approved |
| Galaxy Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee Jawahar Lal Nehru Medical College |
Approved |
| Jivanrekha Institutional Ethics Committee |
Approved |
| Leelavati Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Sleep and Mood |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Two capsules to be taken 45 plus or minus 10 mins before sleep (after dinner) for 21 Days. |
| Intervention |
VL-NL-02 |
Two capsules to be taken 45 plus or minus 10 mins before sleep (after dinner) for 21 Days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals aged between more than or equal to 18 and less than or equal to 50 years with a moderately active lifestyle as assessed by International Physical Activity Questionnaire - Short form (IPAQ - SF)
2. Individuals with mild to moderate sleeping issues as assessed by an ISI score of more than or equal to 8 and less than or equal to 21.
3. Individuals with a history of at least 3 episodes of sleep disturbances in the last month.
4. Individuals with a Fasting Blood glucose (FBG) less than or equal to 125 mg per dl.
5. All individuals who are free from use of sleeping pills for at least 4 weeks before screening
6. Individuals with normal levels of laboratory parameters: Liver profile, lipid profile and kidney profile.
7. Individuals with no more than once per week use of pain-relieving medications
8. Individuals with body mass index between more than or equal to 18 and less than or equal to 30 kg per m square.
9. Typical bedtime between 9 PM and 11 PM
10. Willing to abstain from digital activity 3 hours prior to the PSG analysis.
11. 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. |
|
| ExclusionCriteria |
| Details |
1. FBG more than 125 mg per dl
2. Individuals diagnosed with Hypertension.
3. Individuals having a systolic blood pressure more than or equal to 140 mm Hg and diastolic blood pressure more than or equal to 90 mm Hg.
4. Individuals diagnosed with Type I and Type II Diabetes Mellitus
5. Sleep disorder is secondary to another health problem such as restless leg syndrome, post-operative state etc.
6. Individuals diagnosed with insomnia
7. Consumption of hypnotic drugs (less than 3 months before inclusion)
8. Individuals taking any other sleep promoting supplements and are unwilling to stop taking those supplements for the duration of the study period
9. Individuals with history of sleepwalk
10. Individuals who have bad dreams 2 or more times a week
11. Individuals who are inclined to the lifestyle factors – such as jet lag, night workers and rotational shift work
12. Individuals who currently, or in the past 6 months suffered from any mental-health disorder
13. Individuals who were taking psychotropic medication, herbal preparation, antidepressants, steroids, antihistamines, narcotics or any other illicit drugs in the last three months
14. Individuals diagnosed with chronic medical conditions – such as heart problems, Gastro-intestinal, hepatic, respiratory, psychiatric, kidney, or cardiovascular disorder (less than 3 months before inclusion), and chronic pain since last 6 months.
15. Recent (within 3 months before inclusion) change in lifestyle (food, sport and drug)
17. Addiction, history of addiction, and or substance abuse
18. Heavy drinkers as defined by:
- For men, consuming more than 4 drinks on any day or more than 14 drinks per week
- For women, consuming more than 3 drinks on any day or more than 7 drinks per week
19. Exaggerated consumption of tea (more than or equal to 500 mL per day), coffee (more than or equal to 400 mL per day), or energy drink (more than or equal to 250 mL per day)
20. Individuals on dietary supplements
21. Pregnant or lactating woman
22. Lifestyle habits which would modify the wake-sleep rhythm or which was expected to be modified during the study period (e.g., night work)
23. Known allergy to mushroom |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of VL-NL-02 on sleep quality using the Insomnia Severity Index questionnaire (ISI). |
Day 0, Day 11 & Day 22 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the impact of VL-NL-02 on Mood using Brief Mood Introspection Scale (BMIS) |
Day 1, Day 11 & Day 22 |
| To assess the impact of VL-NL-02 on Dream as assessed by Dream & Sleep Emotions and Anxiety (DSEA) Questionnaire |
Day 1, Day 11 & Day 22 |
| To assess the impact of VL-NL-02 on Restorative sleep by using Restorative Sleep Questionnaire - Weekly Version (RSQ-W) questionnaire |
Day 1, Day 11 & Day 22 |
| To assess the impact of VL-NL-02 on Quality of life using RAND Short form (SF)-36 |
Day 1, Day 11 & Day 22 |
| To assess the impact of VL-NL-02 on Improvement in deep sleep & Rapid eye movement (REM) sleep stages by Polysomnography |
Day 0, Day 10 & Day 21 |
| To assess the impact of VL-NL-02 on Levels of salivary cortisol immediately after awakening |
Day 1 & Day 22 |
| To assess the impact of VL-NL-02 on Levels of serum serotonin. |
Day 1 & Day 22 |
| To assess the impact of VL-NL-02 on Levels of urinary melatonin |
Day 1 & Day 22 |
| To assess the impact of VL-NL-02 on Levels of serum Brain Derived Neurotrophic Factor (BDNF) |
Day 1 & Day 22 |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
13/11/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The
present study is a randomized, placebo-controlled study. 60 individuals will be
screened, and considering a screening failure rate of 20%, approximately 48
participants will 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. |