| CTRI Number |
CTRI/2024/11/077454 [Registered on: 28/11/2024] Trial Registered Prospectively |
| Last Modified On: |
26/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A Clinical Study to Evaluate the Efficacy and Safety of ThymoDream(TM) in Comparison with Melatonin in healthy volunteers with poor sleep quality.
|
|
Scientific Title of Study
|
A Randomized, Double-Blind, Active-Controlled, Cross-over, Clinical Study to Evaluate the Efficacy and Safety of ThymoDream(TM) in healthy volunteers with poor sleep quality. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LCBS-AK-130, Version 1.0 dated 10 Jun 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harshith CS |
| Designation |
Assistant Professor |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
OPD No.03. Department of General Medicine,Ground Floor,No.67,BGS Health and Education City, Uttarahalli Road,Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
9741073960 |
| Fax |
|
| Email |
drharshithcs.research@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
No.9, Mythri Legacy, Kalyan Nagar, Chelekere Main Road
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 Pvt. Ltd |
| Address |
No.9, Mythri Legacy, Kalyan Nagar, Chelekere Main Road
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Akay Natural Ingredients Private Limited, Malaidamthuruthu P. O, Ernakulam, Cochin 683561, Kerala, India
|
|
|
Primary Sponsor
|
| Name |
Akay Natural Ingredients Private Limited |
| Address |
Malaidamthuruthu P. O, Ernakulam, Cochin 683561, Kerala, India |
| Type of Sponsor |
Other [Manufacturer of natural plant based food ingredients and Nutraceutical ingredients] |
|
|
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 Harshith C S |
BGS Global Institute of Medical Sciences |
OPD No.03, Department of General Medicine, Ground Floor, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA |
9741073960
drharshithcs.research@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, BGS Global Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
With Sleep Complaints |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Melatonin capsule |
Oral administration of Melatonin capsule once a day for 7 days |
| Intervention |
ThymoDreamâ„¢ capsule |
Oral administration of ThymoDreamâ„¢ capsule once a day for 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Pittsburgh Sleep Quality Index (PSQI) scores between 5-15
2. Can read and write English.
3. No history of psychiatric conditions
4. Should be ready to abstain from alcohol consumption, smoking and consumption of
caffeinated beverages.
5. Should be ready to be housed during the study as per the protocol requirement.
7. Should be willing to adhere with their routine diet and exercise regimen
throughout the study.
8. Must be willing and able to give informed consent and comply with the study
procedures.
|
|
| ExclusionCriteria |
| Details |
1.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 sleep disorders, 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
6.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 |
Mean change in the following parameters in ThymoDreamâ„¢ arm compared to melatonin from baseline to end of treatment (EOT):
- Melatonin profiling
- Biomarkers |
Baseline and Day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean change in the following parameters in ThymoDreamâ„¢ arm compared to melatonin from baseline to EOT:
•Wrist actigraphy parameters:
•Sleep disturbance assessed by (ESS Score)
|
Baseline, Day 3, Day 6 |
| Safety Parameters |
Baseline, Day 3, Day 6 |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
09/12/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
| This is a randomized (1:1), double-blind, two arm, active-controlled, cross-over clinical study. Healthy adult subjects with sleep complaints, aged 18-70 years meeting all inclusion and no exclusion criteria will be enrolled in the study. After the informed consent process, demographic details, medical history and medication history will be obtained. After passing the eligibility criteria, subjects will be randomized into one of the 2 treatment arms to receive Investigation products (IP), ThymoDream™ or melatonin in 1:1 ratio. The randomized IP will be consumed half an hour before the usual bedtime at night for 7 days. There will be 2 treatment periods. After the first treatment period, subjects will undergo a washout period of 1 week following which they will undergo cross-over of treatment. Prior to initiation of treatment, the eligible subjects will enter a pre-treatment phase (when no IP will be consumed) and will be housed at the study site for 3 days for baseline assessments (Day -2, Day -1). Subjects will be discharged after the randomized IP initiation and Day 1 actigraphy assessment. Melatonin profiling will be performed on baseline and end of the study on each period. The subject’s housing at the study site will be repeated on Day 3, Day 6 and Day 7 for each treatment period. Subjects will be scheduled to sleep and wake at their habitual pre-study sleep wake times . |
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