| CTRI Number |
CTRI/2024/09/074094 [Registered on: 20/09/2024] Trial Registered Prospectively |
| Last Modified On: |
11/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical Study to Investigate the Efficacy of a Multi-Strain Probiotic Formulation in Alleviating Symptoms of Anxiety,Insomnia and Depression. |
|
Scientific Title of Study
|
A Double Blind, Placebo-Controlled, Randomized, Parallel-Group Study to Investigate the Efficacy of a Multi-Strain Probiotic Formulation in Alleviating Symptoms of Anxiety,Insomnia and Depression. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LCBS-UB-135, Version 1.0 14 June 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohan M E |
| Designation |
Dean/Principal, Professor |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
Room No.3, Ground Floor, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
8792516793 |
| Fax |
|
| Email |
drmohanbgsresearch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Servicces Pvt. Ltd. |
| Address |
Department of Clinical Research, 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 Servicces Pvt. Ltd. |
| Address |
Department of Clinical Research, No.9, Mythri Legacy, Kalyan Nagar, Chelekere Main Road
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Unique Biotech Ltd.
Plot no.2, Phase-II, M.N. Park, Kolthur village,
Shameerpet mandal, Medchal Malkajgiri dist
Hyderabad, Telangana, 500 101, India
|
|
|
Primary Sponsor
|
| Name |
Unique Biotech Ltd. |
| Address |
Plot no.2, Phase-II, M.N. Park, Kolthur village,
Shameerpet mandal, Medchal Malkajgiri dist
Hyderabad, Telangana, 500 101, India
|
| Type of Sponsor |
Other [Manufacturer of Probiotics and Nutraceutical Products] |
|
|
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 Mohan M E |
BGS Global Institute of Medical Sciences |
Research Deaprtment, 5th Floor, No. 67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA |
8792516793
drmohanbgsresearch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituional 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: F30-F39||Mood [affective] disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cognisol |
Oral administration of Cognisol twice a day for 84 days
|
| Comparator Agent |
Placebo |
Oral administration of Placebo twice a day for 84 days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Overall healthy subjects, those experiencing moderate mental health concerns such as moderate depression and anxiety disorder along with significant sleep disturbances (such as sleeplessness, depressive episode, recurrent depression, mixed depressive and anxiety disorder) assessed by:i.Beck’s depression Inventory (BDI-II): 21-30 score ii.Hamilton Anxiety Rating Scale (HAM-A): 18-24 score iii.Pittsburgh sleep Quality Index (PSQI): Greather than 5 score. 2.Females of childbearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening. 3.Willing to give written informed consent and comply with the study procedures.
|
|
| ExclusionCriteria |
| Details |
1.Subject with history of i.Use of any anti-depressant drug ii.Use of any antibiotic drug in the past 4 weeks iii.Use of natural health products that affect depression and sleep iv.Use of any sleep medication in the past 4 weeks v.Daily use of probiotic product in the past 2 weeks vi.Use of any type of laxative 2.Subjects with history of psychiatric disorders, severely suicidal and experiencing psychosis or bipolar episode 3.Subjects with of alcohol or substance abuse in the past 6 months4.Subjects with history of epilepsy or uncontrolled seizures 5.Women who are pregnant, breast feeding or planning to become pregnant during the trial 6.Subjects with known Immunodeficiency 7.Subjects with unstable medical conditions or serious diseases/ conditions (e.g. cancer, cardiovascular. renal, lung, diabetes, psychiatric illness, bleeding disorders etc.) 8.Subjects with history of Electroconvulsive therapy (ECT) in the year prior to participation in the study. 9.Subjects taking antidepressant medication or other not-permitted treatment that cannot be safety discontinued. 10.A significant change in the treatment schema with proton-pump inhibitors, metformin, laxatives, systemic steroids, nonsteroidal anti-inflammatory drugs, antipsychotics, or any other medications influencing the microbiota according to present knowledge in the previous four weeks. 11.Subjects having hypersensitivity or history of allergy to any component of the study product.12.Unable to take medication orally or tolerate oral rehydration.13.History of gastric ulcer, duodenal ulcer, combined gastric and duodenal ulcers, upper gastrointestinal bleeding, autoimmune gastritis and GERD.14.Use of any proton pump inhibitor, sucralfate, H2-receptor antagonist, or bismuth preparations or any muscarine receptor antagonist and gastrin receptor antagonist within 2 weeks before initiating study IP therapy.15.Use of any other investigational drug currently or within 30 days prior to study entry. 16.Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study. 17.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
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in the following efficacy parameters assessed in the investigational product arm compared to placebo:
Anxiety & Depression will be assessed through various questionnaires |
Baseline, Day 42, Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in the efficacy parameters including biomarkers for stress, sleep, GI symptoms, inflammatory stress, depression, and alterations in gut microbiota. |
Baseline, Day 42, Day 84 |
| Overall Safety |
Baseline, Day 42, Day 84 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
23/09/2024 |
| 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="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, randomized, placebo controlled, two-arms, parallel group study. A total of 100 moderately stressed adults meeting all inclusion and no exclusion criteria after signing informed consent will be enrolled in the study. After passing the eligibility criteria, the subjects will be randomized into 2 treatment arms in 1:1 ratio to receive either or treatment arm or placebo in capsule form, twice a day for period of 84 days. Questionnaire based assessments will be performed to evaluate the efficacy of the product .Blood samples will be collected for safety and biomarkers analysis. A diary shall be provided to the subjects to record the study IP administration, side effects, and concomitant medication details during the study duration. All subjects shall be instructed to complete the Subject Diary after each study IP administration. Any additional and missed administrations should also be noted in the Subject Diary. Subject Diary shall be used to evaluate study IP administration compliance. |