| CTRI Number |
CTRI/2025/10/096573 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of homoeopathic medicine in improving gut health in patient with Type 2 Diabetes Mellitus |
|
Scientific Title of Study
|
Role of individualized homoeopathic medicine in modulating gut microbiota dysbiosis in patient with 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 Shantanu Satpathy |
| Designation |
Post Graduate Trainee |
| Affiliation |
National Institute Of Homoeopathy |
| Address |
OPD Room No 18, Department of Homoeopathic Materia Medica, National Institute of Homoeopathy, Block GE, Sector 3, Salt Lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
8972927849 |
| Fax |
|
| Email |
shantanusatpathy1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kumaravel V |
| Designation |
Associate Professor |
| Affiliation |
National Institute Of Homoeopathy |
| Address |
OPD Room No 18, Department of Homoeopathic Materia Medica, National Institute of Homoeopathy, Block GE, Sector 3, Salt Lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
9748163274 |
| Fax |
|
| Email |
drkumaravelnih@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kumaravel V |
| Designation |
Associate Professor |
| Affiliation |
National Institute Of Homoeopathy |
| Address |
OPD Room No 18, Department of Homoeopathic Materia Medica, National Institute of Homoeopathy, Block GE, Sector 3, Salt Lake, Kolkata
WEST BENGAL
700106
India |
| Phone |
9748163274 |
| Fax |
|
| Email |
drkumaravelnih@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Homoeopathy, GE Block, Sector 3, Salt Lake, Kolkata-700106, West Bengal, India |
|
|
Primary Sponsor
|
| Name |
National Institute Of Homoeopathy |
| Address |
National Institute Of Homoeopathy, GE Block, Sector 3, Salt Lake, Kolkata-700106, West Bengal, India |
| Type of Sponsor |
Government 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 Shantanu Satpathy |
National Institute Of Homoeopathy |
OPD Room No 18, Department of Homoeopathic Materia Medica, National Institute of Homoeopathy, Block GE, Sector 3, Salt Lake, Kolkata
Kolkata
WEST BENGAL |
08972927849
shantanusatpathy1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethical Committee of the National Institute of Homoeopathy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
Indicated individualized homoeopathic medicine will be prescribed on the basis of totality of symptoms. Dose and frequency of the selected medicine will be as per the susceptibility of the case. Follow up will be done monthly till 6 months from baseline. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Diagnosed Case of Type 2 Diabetes Mellitus
(blood glucose level fasting more than 126mg per dl to less than 200 mg per dl Postprandial Blood glucose more than 200 mg per dl to less than 300 mg per dl HbA1C more than 6.5 percent to 8 percent)
2 Presence of gastrointestinal and dysbiosis symptoms suggestive of gut dysbiosis based on Dys R and Self Dysbiosis Severity Score (SDSS)
In Dys R Scale maximum score is 14 (Score more than 8 Risk of dysbiosis and score less than or equal to 8 No risk of dysbiosis)
Self-Dysbiosis Symptom Severity score Based on important symptoms of dysbiosis. Total number of questions is 15. Each question symptom may get value from 0 to 3 according to their intensity. Maximum number of total scores will be 45 and symptom severity classified as 1 to 15 Mild Dysbiosis 16 to 30 Moderate Dysbiosis 31 to 45 Severe Dysbiosis. Total score exceeding 30 will be considered for study.
3 Urine Indican test positive and or stool culture through MacConkey Agar Media and MRS Agar Media showing evidence of dysbiosis.
4 Participants willing to give consent for participating in the study.
5 Participants who can understand Bengali or Hindi or English language. |
|
| ExclusionCriteria |
| Details |
1 Recent use (within 3 month) of antibiotics probiotics or prebiotics that could alter gut microbiota.
2 History of inflammatory bowel disease (IBD) irritable bowel syndrome (IBS) or chronic liver disease. (based on previous medical diagnosis or by red flag signs for example rectal bleeding weight loss fever).
3 Ongoing treatment with corticosteroids and immunosuppressants.
4 Alcohol or other substance abuse.
5 Pregnant and lactating mothers.
6 Unstable psychiatric illnesses. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in gastrointestinal and dysbiosis symptoms, assessed using the Self-Dysbiosis Severity Score (SDSS) and laboratory parameters (Urine Indican Test or/and Stool Culture through MacConkey Agar Media and MRS Agar Media). |
Baseline, 3rd month and 6th months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in fasting blood glucose level in individual with T2DM while observing changes in dysbiosis during homoeopathic treatment. |
Baseline, 3rd month and 6th months. |
|
|
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)
|
10/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/11/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 research proposal focuses on investigating the role of individualized homoeopathic medicine in modulating gut microbiota dysbiosis in patients with Type 2 Diabetes Mellitus (T2DM). Background: T2DM is a chronic metabolic disease characterized by hyperglycemia that affects millions of people worldwide. Gut microbiota dysbiosis is associated with the development of T2DM. Justification: Conventional T2DM treatments often overlook underlying microbial imbalances. This study explored the potential of homoeopathy in addressing both glycemic control and gut microbiota dysbiosis. Research question: This study aimed to determine whether individualized homoeopathic medicine can significantly modulate gut microbiota dysbiosis in T2DM patients. Objectives: To evaluate the effect of individualized homoeopathic medicine on gut microbiota dysbiosis in T2DM patients using Dys-R) and Self Dysbiosis Severity Score (SDSS) as primary objectives and changes in glycemic parameters and other related outcomes as secondary outcomes. Methodology: The study will likely involve clinical assessments and laboratory tests to measure changes in the gut microbiota and diabetes-related parameters. The study will follow up with the enrolled cases monthly or as needed. Outcome: The primary assessment will use the Self-Dysbiosis Severity Score (SDSS) at baseline, 3 months, and 6 months, along with fasting blood sugar monitoring. Statistical analyses will be used to compare the data from these time points. Changes in gastrointestinal and dysbiosis symptoms using the SDSS and Laboratory parameters, such as the Urine Indican Test and, or Stool Culture (MacConkey Agar Media and MRS Agar Media), are the primary outcome measures. Measurements were taken at baseline, 3 months, and 6 months. |