| CTRI Number |
CTRI/2024/07/070841 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
05/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical study on Sleep Rhythm Capsules in sleep disturbance |
|
Scientific Title of Study
|
A Randomized, double blind, placebo controlled, multicentric,
interventional Prospective, clinical Study to evaluate efficacy and safety of Sleep Rhythm Capsules (SRC) in healthy participants with mild to moderate sleep disturbances |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TLS/SRC/2024/1, Version 1.0, 30th May 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Madhuri Rohidas Alhat |
| Designation |
Principal Investigator |
| Affiliation |
Nirvikar Ayurveda Hospital |
| Address |
Nirvikar Ayurveda Hospital
Department of General OPD,
OPD No. 1, First Floor, B Wing, Jay Ganesh Samrajya, Nashik Hwy, Sector No. 3, Bhosari, Pune, Pimpri Chinchwad, Maharashtra
Pune
MAHARASHTRA
411039
India |
| Phone |
9822065090 |
| Fax |
|
| Email |
madhurialhat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Satyendra Kumar |
| Designation |
Senior Manager- clinical Research |
| Affiliation |
Transformative Learning Solutions Pvt Ltd |
| Address |
Transformative Learning Solutions Pvt Ltd
Department of Clinical Research, 3rd Floor, Veritas Business Suit, Sector 53, Gurgaon, Haryana Gurgaon
HARYANA
Gurgaon
HARYANA
122002
India |
| Phone |
09891253516 |
| Fax |
|
| Email |
satyendra.kumar@transformative.in |
|
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
Mumbai (Suburban)
MAHARASHTRA
400064
India |
| Phone |
09322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Transformative Learning Solutions Pvt Ltd 3rd Floor, Veritas Business Suit, Sector 53, Gurgaon, Haryana- 122002 |
|
|
Primary Sponsor
|
| Name |
Transformative Learning Solutions Pvt Ltd |
| Address |
3rd Floor, Veritas Business Suit, Sector 53, Gurgaon, Haryana- 122002 |
| Type of Sponsor |
Other [FMCG (Fast moving Consumer Goods)] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nikhil H Joglekar |
D.Y. Patil School of Ayurveda |
Department of Kayachikitsa
OPD NO 1, 1st floor
Sector 7. Nerul, Navi Mumbai 400706
Mumbai (Suburban)
MAHARASHTRA |
8767772865
drnikhiljoglekar@gmail.com |
| Dr Amol Ravindra Hartalkar |
Nirvikar Ayurveda Hospital |
Department of General OPD,
OPD No. 1, First Floor, B Wing, Jay Ganesh Samrajya, Nashik Hwy, Sector No. 3, Bhosari, Pune, Pimpri Chinchwad, Maharashtra 411039
Pune
MAHARASHTRA |
9850393788
amolhartalkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| D Y Patil University School of Ayurved, Navi Mumbai |
Approved |
| Institutional Ethics Committe, NIrvikar Ayurved Hospital, Pune, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
mild to moderate sleep disturbances |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo Capsule |
2 Capsules at bedtime daily with water for 30 days |
| Intervention |
Sleep Rhythm Capsules (SRC) |
2 Capsules 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 aged greater than or equal to 21 and less than 65 years at the time of obtaining written informed consent
2. Participants with score between 7-21 on ISI (Insomnia severity index)
3. Participants willing to sign inform consent form and ready to follow the study protocol requirements
4. A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout study period
|
|
| ExclusionCriteria |
| Details |
1. 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 & generalized anxiety disorder
5. Participants with history of drug or alcohol addiction or abuse within the past 12 months
6. Participants with habit of smoking Cigarette (Average of more than 5 cigarettes per day over the last 5 years)
7. Participants with known history of hepatitis B and or C
8. Participants with history of malignancy less than or equal to 5 years prior to study participation
9. Participants with shift work disorders and other psychiatric disorders which need medication
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/her participation in, and completion of the protocol
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in sleep parameters [Onset of sleep latency (SOL), Sleep Efficiency (SE), Total Bed time (TBT), Total Sleep Time (TST), Wake after Sleep Onset (WASO), Light Sleep, Deep Sleep, REM Sleep,] using Actigraphy
2. Change in sleep efficiency (Total sleep time/ Time in bed X 100) time of sleep onset, number of awakenings and wake time after sleep onset, (as per participant diary).
|
Baseline visit, Day 7, Day 15, and Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Change in severity of sleep disturbance using Insomnia Severity Index
2 Change in daytime fatigue using Fatigue Severity Scale (FSS)
3.Change in daytime mood, ability to function at work, concentration
4. Change in Quality of sleep on Pittsburgh Sleep Quality Index (PSQI)
5. Change in stress assessed on perceived stress scale (PSS)
6. Global assessment for overall change (CGI I)
7. Assessment of non habit forming property of the study products
8. Change in feeling of relaxation, calmness, deep sleep on VAS
9. Assessment of Restless thoughts, racing thoughts before sleep
10. Change in quality of life by assessing WHO QOL
11. Change in day time drowsiness, grogginess or brain fog
12. Assessment of safety and tolerability of study products
|
Baseline visit, Day 7, Day 15, and Day 30 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
25/07/2024 |
| 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,
Controlled, Double Blind clinical study to evaluate efficacy and safety of Sleep
Rhythm Capsules (SRC) in healthy participants with mild to moderate sleep
disturbances. The study will be carried out in 2-3 centers in
India. As per computer generated randomization list, subjects will be assigned
to either of the two groups (study product or placebo) in 1 :1 ratio. Subjects
will be asked to take given product in a dose of 2 capsule at bedtime for 30
days. Primary
objectives of the study will be to assess sleep parameters [Onset of sleep
latency (SOL), Sleep Efficiency (SE), Total Bed time (TBT), Total Sleep Time
(TST), Wake after Sleep Onset (WASO), Light Sleep, Deep Sleep, REM Sleep,]
using Actigraphy and sleep efficiency (Total sleep time/ Time in
bed*100) time of sleep onset, number of awakenings and wake time after sleep
onset, (as per participant diary). The secondary objectives of the study will
be to assess change in severity of sleep disturbance using Insomnia Severity
Index, change in daytime fatigue
using Fatigue Severity Scale (FSS), Change
in daytime mood, ability to function at work, concentration, on a graded
scale (VAS), change in Quality of sleep on Pittsburgh Sleep Quality Index
(PSQI), change in stress assessed on
perceived stress scale (PSS), global assessment for overall change (CGI-I) by
investigator and by the participants, non-habit forming property of the study
product by evaluation of clinical symptoms (withdrawal) post stopping study
product (10 Days after end of study intervention period), change in feeling of relaxation, calmness,
deep sleep using on VAS, restless
thoughts/racing thoughts before sleep, change
in quality of life by assessing WHO-QOL, change in day time
drowsiness, grogginess or brain fog on next day after product consumption
(causality assessment), safety and tolerability of study products by assessing
adverse events/ Adverse drug reactions and Laboratory related safety parameters
on baseline visit, day 7, day 15,and day 30 |