| CTRI Number |
CTRI/2019/05/018964 [Registered on: 06/05/2019] Trial Registered Prospectively |
| Last Modified On: |
08/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Functional Food] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical study to evaluate the effect of ITC-SLB on sleep in healthy Human Volunteers. |
|
Scientific Title of Study
|
A randomized, placebo-controlled, parallel-group clinical study to evaluate the efficacy
and safety of ITC-SLB on sleep quality in healthy subjects having sleep disturbances. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aman Khanna |
| Designation |
Principal Investigator |
| Affiliation |
Aman Hospital and Research Centre |
| Address |
Room No:1,Department of general medicine,Aman Hospital and Research Centre Pvt Ltd. 15 Shaswat opposite ESI Hospital
Vadodara
GUJARAT
390021
India |
| Phone |
|
| Fax |
|
| Email |
amankhanna11974@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Private Limited |
| Address |
#9, 1st Floor, Mythri Legacy, chelekere Main Road, Kalyan nagar,
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Private Limited |
| Address |
#9, 1st Floor, Mythri Legacy, chelekere Main Road, Kalyan nagar,
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| ITC Life Sciences and Technology Centre #3, 1st Main, Peenya Industrial Area, Bengaluru – 560058 Karnataka, India |
|
|
Primary Sponsor
|
| Name |
ITC Life Sciences and Technology Centre |
| Address |
#3, 1st Main, Peenya Industrial Area, Bengaluru |
| Type of Sponsor |
Other [FMCG] |
|
|
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 Aman Khanna |
Aman Hospital and Research Center |
Room No: 1, Department of General medicine, 15 Shaswat opposite ESI Hospital
Vadodara
GUJARAT
Vadodara
GUJARAT |
990402122
amankhanna11974@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Aman Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Sleep disturbance |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ITC-SLB 1 |
Oral administration of ITC-SLB 1 two per day for 7 days.
|
| Comparator Agent |
ITC-SLB 2 |
Oral Administration of ITC-SLB 2 two per day for 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Urban individuals with NCCS rating of Lower A (A2 and A3) and Higher B (B1) grades 3
2. PSQI scores between 5-15
3. Can read and write English.
4. No history of psychiatric conditions
5. Should be ready to abstain from alcohol consumption, smoking and consumption of caffeinated
beverages.
6. Should be willing to adhere with their routine diet and exercise regimen throughout the study.
7. Must be willing and able to give informed consent and comply with the study procedures |
|
| ExclusionCriteria |
| Details |
Subject suffering from mental disorders, clinical anxiety, depression, Cushing’s syndrome and other
major ailments.
2. Subjects on medication/dietary supplements that may affect the measured responses, including
medicines for anxiety, depression; prednisone, dexamethasone and other steroids administered orally
or intravenous
3. Alcohol addicts, smokers of more than 10 cigarettes/day.
4. Pregnant and lactating women
5. Subjects on hormonal birth-control measures
Subjects currently on any medication on a regular basis.
7. Subjects allergic to herbal products, nuts or any component of the study product
8. Currently participating or having participated in another clinical trial during the last 3 months prior to
the beginning of this study
9. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study
or prevent the subject from completing the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Actigraphy and Sleep Quality questionnaire scores in comparison with baseline |
Day 0, Day 8, Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Salivary Melatonin level |
Day 0, Day 1, Day 7, Day 8, Day 13, Day 14 |
| Safety Assessment |
Day 0, Day 1, Day 7, Day 8, Day 13, Day 14 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/05/2019 |
| Date of Study Completion (India) |
16/10/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
"None Yet" |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a double blind, randomized (1:1), placebo controlled, parallel group,
two-arm study. Healthy subjects meeting
all inclusion and no exclusion criteria after signing a written informed consent will be enrolled in the
study.
After passing the eligibility criteria, subjects will be randomized into 2 treatment arms to receive ITC-SLB
(food formulation bar) or placebo in 50:50 ratio. The test formulation (ITC-SLB) or placebo (2 bars) will
be consumed half an hour before sleeping at night, from Day 7 to Day 13.
A subgroup of the study population ( who will give consent will be provided
with wrist actigraphy devise which has to be worn on wrist for 14 days for sleep analysis.
Subjects will be administered with questionnaires to evaluate the quality of sleep. They will be requested to document the previous night
sleep schedule and quality details in a sleep diary and self-assessment questionnaire every morning.
Salivary samples for melatonin analysis will be collected just before the volunteer goes to sleep and next morning
(immediately after waking up) on the scheduled days. over all safety and Adverse Events will be also assess during the study. |