| CTRI Number |
CTRI/2025/05/087114 [Registered on: 20/05/2025] Trial Registered Prospectively |
| Last Modified On: |
19/05/2025 |
| 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 Safety and Efficacy of B-Lit Bacopa on Stress and Sleep in Subjects with Non-Chronic Stress |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Safety and Efficacy of B-Lit Bacopa on Stress and Sleep in Subjects with Non-Chronic Stress |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LCBS-SN-164, Version 1.0 dated 03 Apr 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shashank S Gowda |
| Designation |
Associate Professor |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
OPD No.3,Ground Floor, Department of General Medicine, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
9741073960 |
| Fax |
|
| Email |
drshashank.research@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Managing Director and CEO |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
Department of Clinical Research, No.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 |
Managing Director and CEO |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
Department of Clinical Research, No.9, 1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Samriddh Nutractive Pvt. Ltd.,
402 Thirath Towers, Road Number 7, Zahara Nagar, Banjara Hills, Hyderabad, Telangana 500034
India |
|
|
Primary Sponsor
|
| Name |
Samriddh Nutractive Pvt. Ltd. |
| Address |
402 Thirath Towers, Road Number 7, Zahara Nagar, Banjara Hills, Hyderabad, Telangana 500034
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 Shashank S Gowda |
BGS Global Institute of Medical Sciences |
OPD No.3,Ground Floor, Department of General Medicine, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA |
9741073960
drshashank.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 |
| Patients |
(1) ICD-10 Condition: G478||Other sleep disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
B-Lit Bacopa |
Single capsule of B-Lit Bacopa once a day for 84 days |
| Comparator Agent |
Placebo |
Single capsule of Placebo once a day for 84 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.BMI of 18.5 kg per meter square to 29.9 kg per meter square.2.Non-chronic stress of not more than 12 weeks at the time of screening.3.Mild to moderate levels of stress on PSS score greater or equal to 10 and lesser or equal to 26.4.No reported history of psychological or mental disorders.5.Willing and able to give informed consent.6.Willing to stop use of other herbal supplements, over-the-counter medications, or prescriptions during the study.7.Avoid the consumption of any medications or preparations that are intended to alleviate tension, anxiety, or mood during the course of the study.8.Refrain from consuming alcohol 24 hours prior to the study visit days.9.Refrain from vigorous physical activity 12 hours prior to study visit days.10.Refrain from consuming caffeine and caffeine-containing products 12 hour prior to study visit days.11.Agree to maintain the usual lifestyle throughout the study period.12.Female subjects of childbearing potential practicing an acceptable method of birth control. |
|
| ExclusionCriteria |
| Details |
1.Hypersensitivity or history of allergy to the study product.2.History of cardiovascular disease, neurological disorders, gastrointestinal disorders, kidney or liver disease, uncontrolled metabolic disorders that could affect the study outcomes.3.Malignant disease or any concomitant end-state organ disease.4.Psychiatric diagnosis including anxiety or depression.5.Uncontrolled hypertension (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg) at screening.6.Participants with a history of drug and or alcohol abuse at the time of enrolment.7.Participants who are pregnant, breastfeeding, or intending to conceive during the study period.8.Participants with positive Urine Pregnancy Test at screening or randomization visit.9. Participants who have received any experimental medicine or device within 3 months preceding trial enrolment. |
|
|
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 on stress using Perceived Stress Scale assessed for B-Lit Bacopa compared to placebo |
Baseline, Day 0, Day 14, Day 28, Day 56 and Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in Sleep assessment parameters |
Day 0 and Day 84 |
| Mean change in questionnaire based assessments |
Baseline, Day 0, Day 14, Day 28, Day 56 and Day 84 |
| Mean change in Biomarkers |
Baseline and Day 84 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
02/06/2025 |
| 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="6"
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 double blind, placebo-controlled, randomized clinical trial. Adult 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 (1:1) to receive either B-Lit Bacopa or Placebo for 12 weeks. Clinical assessments shall include all the measures required for the primary and secondary objectives. The total study duration for the clinical part shall be a maximum of 90 days which includes 5 days of screening period, randomization 1 day and supplementation period of 84 days and end of study visit at 84 days. Subjects will visit the study site on 6 different occasions during the study duration. |