| CTRI Number |
CTRI/2024/03/063637 [Registered on: 05/03/2024] Trial Registered Prospectively |
| Last Modified On: |
02/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study on sleep tablets in sleep problem |
|
Scientific Title of Study
|
A pilot clinical study to evaluate efficacy and safety of 3 different formulations in healthy participants with insomnia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SCITECH ID 2023 1, Version 1.0, 6th Jan 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vineet Kumar Malhotra |
| Designation |
Physician |
| Affiliation |
Vignaharta Health Care Clinic |
| Address |
Vignaharta Health Care Clinic
Department of Medicine, OPD No. 1, first Floor, Vignaharta
Health Care Clinic, Sr.No.15, Mangal Hights, Pune Solapur Road, Hadapsar,Pune, 412308,MAHARASHTRA India
Pune
MAHARASHTRA
412308
India |
| Phone |
9404226170 |
| Fax |
|
| Email |
vinekmalhotra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd. |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd. Fourth Floor,
A Wing 402 A,B,C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad west, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd. |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd. Fourth Floor,
A Wing 402 A,B,C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad west, Mumbai
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| SciTech Specialties Pvt. Ltd.
501 DLH Park, S. V. Road,
Goregaon (West), Mumbai - 400 062 |
|
|
Primary Sponsor
|
| Name |
SciTech Specialties Pvt. Ltd. |
| Address |
501 DLH Park, S. V. Road,
Goregaon (West), Mumbai - 400 062
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vineet Kumar Malhotra |
Vignaharta Health Care Clinic |
Department of Medicine OPD, OPD No. 1, first Floor, Vignaharta
Health Care Clinic, Sr.No.15, Mangal Hights, Pune Solapur Road
Hadapsar,Pune, 412308,MAHARASHTRA India
Pune
MAHARASHTRA |
9404226170
vinekmalhotra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee, Mhaske Hospital and Research Centre, Hadapsar, Pune. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Insomnia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chammomile Flower Extract 35mg + Melatonin 5mg OD-EffTabs |
1 Tablet at bedtime daily with water for 30 days. |
| Intervention |
Melatonin 5mg + Jatamansi Extract 5mg OD-EffTabs |
1 Tablet at bed time daily with water for 30 days. |
| Comparator Agent |
Melatonin OD-EffTabs |
1 Tablet at bedtime daily with water for 30 days. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants having average (average of three night readings before baseline visit) sleep initiation greater than or equal to 30 minutes and effective sleep duration of less than or equal to 6 hours on Ballistocardiography
2. Participants diagnosed with insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM V TR)
3. Insomnia Severity Index score more than 7 and less than or equal to 21
4. Participants willing to sign inform consent form and ready to follow the study protocol requirements
5. Female participants with reproductive potential with a negative pregnancy test (Urine) and agree to use contraception throughout study period
6. Participants willing to stop alcohol, caffeine, and nicotine consumption while in the study
|
|
| ExclusionCriteria |
| Details |
Participants with history or diagnosis of secondary sleep disorder (any other underlying medical or surgical condition diagnosed on the basis of history and clinical examination by the investigator)
2. Participants with history of any neurological disorder causing interference in sleep
3. Participants with history of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires medication
4. Participants with on going depression and generalized anxiety disorder treatment
5. Participants with history of substance abuse or dependence for the last 5 years
6. Participants taking certain prohibited medications like opium, cannabis (marijuana) and methamphetamines etc.
7. Participants with habit of smoking Cigarette etc. (More than 5 cigarettes per day)
8. Participants with known history of hepatitis B and or C
9. Participants with history of malignancy less than or equal to 5 years prior to study participation
10. Participants with known hypersensitivity to any of the ingredients of study products
11. Participants with other conditions, which in the opinion of the investigators, makes the participant unsuitable for enrolment or could interfere with his or her participation in, and completion of the protocol
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in sleep parameters (Time in bed, sleep initiation, effective sleep duration, Sleep continuity (Awakenings), tossing and turning, light sleep, NREM (non rapid eye movement) sleep, REM (rapid eye movement) sleep, Average Resting Breathing Rate (bpm), Max Resting Breathing Rate (bpm), Average Resting Heart Rate (bpm), Max Resting Heart Rate (bpm) using Ballistocardiography |
Screening Visit (up to 3 days), Day 0, Day 15 and Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in severity of Insomnia using Insomnia Severity Index
2. Change in quality of sleep on Pittsburgh Sleep Quality Index
3. Change in stress on perceived stress scale
4. Change in daytime fatigue using Fatigue Severity Scale
5. Change in daytime mood, ability to function at work, concentration, and memory on a graded scale
6. Change in participant reported total sleep time (as per participant diary)
7. Change in sleep efficiency, Time to sleep onset. Number of awakenings, Wake time after sleep onset based on participant diary
8. Global assessment for overall change by investigator and by participant
9. Assessment of tolerability of study products by assessing adverse events
10. Assessment of Laboratory related safety investigations
|
Screening Visit (up to 3 days), Day 0, Day 15 and Day 30 |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
11/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
It is a randomized, open label, active
controlled, multi-centric, interventional, prospective, pilot clinical study to
evaluate efficacy and safety of 3 different formulations in healthy
participants with insomnia. The study will be carried out at 1 to 2 centers in
India. As per computer generated randomization list, participants will be
either randomized to one of the three groups in 1:1:1 ratio. Participants will
be asked to take given product in a dose of 1 effervescent tablet at bed time
daily with water for 30 days. The primary objectives of the study will be to
assess change in sleep parameters (Time in bed, sleep initiation, effective
sleep duration, Sleep continuity (Awakenings), tossing and turning, light
sleep, NREM (non rapid eye movement) sleep, REM (rapid eye movement) sleep,
Average Resting Breathing Rate (bpm), Max Resting Breathing Rate (bpm), Average
Resting Heart Rate (bpm), Max Resting Heart Rate (bpm) using
Ballistocardiography. The secondary objectives will be to assess change in
severity of Insomnia using Insomnia Severity Index, quality of sleep on
Pittsburgh Sleep Quality Index, stress on perceived stress scale, daytime
fatigue using Fatigue Severity Scale, daytime mood, ability to function at
work, concentration, and memory on a graded scale, change in participant reported
total sleep time (as per participant diary), change in sleep efficiency, Time
to sleep onset. Number of awakenings, Wake time after sleep onset based on
participant diary, global assessment for overall change by investigator and by
participant, assessment of tolerability of study products by assessing adverse
events, and assessment of Laboratory related safety investigations on Screening
Visit (up to 3 days), Day 0, Day 15 and Day 30 |