| CTRI Number |
CTRI/2025/07/090888 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Probiotic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
effect of synbiotics in elderly diabetic patients |
|
Scientific Title of Study
|
A Gut-Targeted Synbiotics with Vildagliptin–Metformin in Elderly Type 2 Diabetes: Impact on Glycemic Control, Oxidative Stress, Inflammatory Respnse and Insulin Sensitivity – An Open-Label Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kala P |
| Designation |
Professor |
| Affiliation |
|
| Address |
Department of Pharamcology SRM Medical College Hospital and Research Centre, Kattankulathur. Tamilnadu. 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9962393389 |
| Fax |
|
| Email |
bharathiclinic2019@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kala P |
| Designation |
Professor |
| Affiliation |
|
| Address |
Department of Pharamcology SRM Medical College Hospital and Research Centre, Kattankulathur. Tamilnadu. 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9962393389 |
| Fax |
|
| Email |
bharathiclinic2019@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kala P |
| Designation |
Professor |
| Affiliation |
|
| Address |
Department of Pharamcology SRM Medical College Hospital and Research Centre, Kattankulathur. Tamilnadu. 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9962393389 |
| Fax |
|
| Email |
bharathiclinic2019@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kala P |
| Address |
Department of Pharamcology SRM Medical College Hospital and Research Centre, Kattankulathur. Tamilnadu. 603203 |
| 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 |
| JamunaRani |
SRM Medical College Hospital and Research Centre |
Room.42, Department of Diabetology, SRM Medical College Hospital and Research Centre. SRM Nagar, Kattankulathur. 603203. Tamilnadu. India
Kancheepuram
TAMIL NADU |
9840279010
hod.medpharm.ktr@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SRM Medical College Hospital and Research Centre, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Synbiotics |
Group 2 will be prescribed Synbiotics, Vildagliptin 50mg and Metformin 500mg in fixed dose once a day after food in the morning |
| Comparator Agent |
Vildagliptin 50mg and Metformin 500mg |
Group 1 will be prescribed Vildagliptin 50mg and Metformin 500mg in fixed dose once a day after food in the morning
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Age group- 60- 85 years
Both the genders
Diagnosed with type 2 diabetes mellitus patients
HbA1c level between 7 to 8%
Diabetes with or without hypertension
Diabetes with or without dyslipidaemia
|
|
| ExclusionCriteria |
| Details |
Diabetes with renal failure
Diabetes with liver failure
Age below 60 years
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of Serum Glucose level and HbA1C level |
Reduction of Serum Glucose level and HbA1C level |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction of Inflammation and Oxidative Stress and Insulin sensitivity |
3 months |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
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 4 |
|
Date of First Enrollment (India)
|
20/08/2025 |
| 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="3"
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
|
Synbiotics may have a particular application in elderly populations, especially in terms of protection against infections, inflammation, oxidative stress and also in the prevention of several age-related diseases.
Synbiotic agents along with vildagliptin reduce the glucose level, inflammation and oxidative stress in geriatric population with Type 2 diabetes mellitus and also synbiotics potentiate the action of DPP4 inhibitors
Metformin is the conventional drug irrespective of age group and it prevents the gut leakage and reduce the gut inflammation.
The role of synbiotic agents along with Vildagliptin and Metformin in geriatric population with Type 2 Diabetes Mellitus is not done.
|