| CTRI Number |
CTRI/2025/08/093165 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
19/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Can Probiotics Help Control Blood Sugar in Type 2 Diabetes |
|
Scientific Title of Study
|
EXPLORING THE THERAPEUTIC POTENTIAL OF PROBIOTICS IN MODULATING GLYCEMIC LEVELS IN TYPE 2 DIABETES MELLITUS |
| 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 P Dhivyaprasath |
| Designation |
Assistant Professor |
| Affiliation |
Swamy Vivekanandha College of Pharmacy |
| Address |
Room no: G6, Ground Floor, Department of Pharmacy Practice, Swamy Vivekanandha College of Pharmacy, Elayampalayam, Tiruchengode
Namakkal
TAMIL NADU
637202
India |
| Phone |
9688588833 |
| Fax |
|
| Email |
drdpsvcp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Arthanareeswaran |
| Designation |
General Medicine Consultant |
| Affiliation |
Vivekanandha Medical Care Hospital |
| Address |
Room: 02, General Medicine Op, Ground Floor,
Vivekanandha Medical Care Hospital,
Elayampalayam, Tiruchengode.
Namakkal
TAMIL NADU
637205
India |
| Phone |
9442552953 |
| Fax |
|
| Email |
arthashan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Arthanareeswaran |
| Designation |
General Medicine consultant |
| Affiliation |
Vivekanandha Medical Care Hospital |
| Address |
Room: 02, General Medicine Op, Ground Floor,
Vivekanandha Medical Care Hospital,
Elayampalayam, Tiruchengode.
Namakkal
TAMIL NADU
637205
India |
| Phone |
9442552953 |
| Fax |
|
| Email |
arthashan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vivekanandha Medical Care Hospital,
Room: 02, General Medicine Op, Ground Floor,
Vivekanandha Educational Institution,
Elayampalayam, Tiruchengode. |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Nil |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 P Dhivyaprasath |
Vivekanandha Medical Care Hospital |
Room: 02, General Medicine Op, Ground Floor,
Vivekanandha Medical Care Hospital,
Elayampalayam, Tiruchengode.
Namakkal
TAMIL NADU |
9688588833
drdpsvcp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vivekanandha medical care hospital |
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 |
Adjuvant Therapy |
Adding a probiotic with a treatment, not stopping any drug or any treatment for the patient. |
| Comparator Agent |
Bioticas |
Stains Contain :
Lactobacillus acidophillus, Lactobacillus
rhamnosus, Bifidobacterium longum, Bifidobacterium bifidum, Saccharomyces boulardii, Streptococcus
Mistciophilos, Fructo Oligo Saccharide (prebiotic) |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
* Patients above 30 and below 65 years.
* Patients diagnosed with Type 2 Diabetes Mellitus within 2years
* HbA1C range between 6.5% - 9.0% (Moderate glycemic control)
* hs - CRP with the range 1.0 – 10.0 mg/dL
* No major changes in treatment for X 3 months.
* Patients who agree to participate by knowing the objectives of the study and voluntarily participate |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improved Glycemic Control: A significant reduction in HbA1c, fasting blood glucose (FBG), Postbrandial blood gulcose, HOMA-IR levels
in the probiotic group compared to the control group.
Reduction in hsCRP Levels: A notable decrease in high-sensitivity C-reactive protein (hsCRP), indicating
reduced systemic inflammation, which is linked to better glycemic control |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NIl |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
29/08/2025 |
| Date of Study Completion (India) |
24/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
|