| CTRI Number |
CTRI/2024/07/069746 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
01/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Gut Bacteria on Depressive Disorder when used along with Tablet Escitalopram.
|
|
Scientific Title of Study
|
Effectiveness of Gut Microbiome as an add on to T.ESCITALOPRAM ( Anti Depressant ) in Depressive Disorder: A Randomised Double Blinded Prospective Treatment Evaluation Study
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K ASHOK REDDY |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
SVS Medical College Hospital |
| Address |
Department of Psychiatry
SVS Medical College Hospital
Yenugonda
Mahabubnagar
Mahbubnagar
TELANGANA
509001
India |
| Phone |
9391041531 |
| Fax |
|
| Email |
kashokreddy60@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K ASHOK REDDY |
| Designation |
Professor and HOD |
| Affiliation |
SVS Medical College and Hospital |
| Address |
Department of Psychiatry
SVS Medical College and Hospital
Yenugonda
Mahabubnagar
Mahbubnagar
TELANGANA
509001
India |
| Phone |
9391041531 |
| Fax |
|
| Email |
kashokreddy60@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K ASHOK REDDY |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
SVS Medical College Hospital |
| Address |
Department of Psychiatry
SVS Medical College Hospital
Yenugonda
Mahabubnagar
Mahbubnagar
TELANGANA
509001
India |
| Phone |
9391041531 |
| Fax |
|
| Email |
kashokreddy60@gmail.com |
|
|
Source of Monetary or Material Support
|
| Material Support supply of Capsule GUTBRAX by PSYNE HEALTHCARE PRIVATE LIMITED
H NO 11 10 288 by 1
First floor
Road No 2
Street No 2
Vijayapuri colony
Saroornagar Mandal
Ranga Reddy
Telangana
India
|
| SVS Medical College Hospital
Yenugonda
Mahabubnagar-509001
Telangana state
India |
|
|
Primary Sponsor
|
| Name |
SVS Medical College and Hospital |
| Address |
Department of Psychiatry
Yenugonda
Mahabubnagar-509001
Telangana state
India |
| Type of Sponsor |
Private medical college |
|
|
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 K Ashok Reddy |
SVS Medical College and Hospital |
Room Number 2
Department of Psychiatry
Mahbubnagar
TELANGANA |
9391041531
kashokreddy60@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee-SVS Medical college and Hospital-CDSCO |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F322||Major depressive disorder, singleepisode, severe without psychotic features, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
C.GUTBRAX |
C.GUTBRAX
Dose 23 Billion CFUs of Psychobiotics plus Vitamin D3 600 IU plus Fructo Oligosacharides 100mg
Frequency Two capsules per day
Route of administration is per oral
Total duration is 10 weeks
|
| Intervention |
T.ESCITALOPRAM AND C.GUTBRAX |
T.ESCITALOPRAM
Dose 10mg
Frequency one tablet daily in the morning
Route of administration is per oral
Total duration is 10 weeks
C.GUTBRAX
Dose 23 Billion CFUs of Psychobiotics plus Vitamin D3 600 IU plus Fructo Oligosacharides 100mg
Frequency Two capsules per day
Route of administration is per oral
Total duration is 10 weeks
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who have been diagnosed as moderate or severe depressive disorder according to ICD 10 first episode or multiple episodes.
2.Subjects willing to give consent. |
|
| ExclusionCriteria |
| Details |
1. Patients diagnosed with Mild Depressive Disorder.
2. Patients diagnosed with Bipolar Depression.
3. Patients with a Pre-existing mental illness other than Depressive disorder.
4. Patients who are diagnosed with Thyroid abnormalities.
5. Patients who were diagnosed with Gastrointestinal infections or with inflammatory bowel disease during 4 weeks before inclusion into the study.
6. Patients who have been on Steroids or Antibiotics during 4 weeks before inclusion into the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in the Hamilton depression rating score (HAM -D 21) is taken as response to the cap.GUTBRAX. |
Hamilton depression rating score assessment is done on day of recruitment into study then after 2 weeks ,6 weeks and 10 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assess the tolerability of the C.GUTBRAX. |
Assessing the tolerabilty after 2 weeks of initiation of treatment then after 6 weeks and 10 weeks. |
|
|
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 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
1.Patients diagnosed as Depressive disorder according to ICD 11[L2-6A7 ] will be recruited into the study. Intake proforma having socio demographic profile will be filled .
2.HAM-D[21] will be administered to assess the severity.
3.Baseline investigations CBC,TFT,ESR will be done.
4.Patients will be grouped based on Simple random sampling procedure.
5.First group will be treated withT.ESCITALOPRAM 10mg/day and Rescue medication will be used wherever required.
6.Second group will be treated with T.ESCITALOPRAM 10mg/day plus C.GUT BRAX 2 capsules/day and Rescue medication will be used wherever required.
7.After 2 weeks of initiation of treatment, all the patients will be subjected to clinical evaluation and adminstered with HAM-D [21] to assess the improvement and the dose of T.ECITALOPRAM will be adjusted as per the clinical requirement and continued with medication for 4 weeks .
8.After 6 weeks from the date of recruitment all the patients will be subjected to clinical evaluation and adminstered with HAM-D [21]to assess the improvement and as per the clinical requirement dose of T.ESCITALOPRAM will be adjusted and continued with medication for 4 weeks .
9.After 10 weeks from the date of recruitment ,all the patients will be subjected to clinical evaluation and adminstered with HAM-D[21] to assess the improvement.
10.All the findings will be entered into the MS Excel (version :2019)sheet then will do statistical analysis using SPSS(VERSION:23)
11.Analysed data will be presented in the form of Tables, Pie diagram and Grouped or stacked bar diagram .
|