| CTRI Number |
CTRI/2025/09/093969 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Evaluation of Constitutional Homoeopathic Treatment in Type 2 Diabetes Mellitus |
|
Scientific Title of Study
|
Homoeopathic Management Of Diabetes Mellitus Type 2 Based On Constitutional Approach: A Prospective 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 |
Sanghani chandni harsukhbhai |
| Designation |
MD scholar Part 2 |
| Affiliation |
S. S. Agrawal Homoeopathic Medical College And General Hospital, Navsari |
| Address |
PG Division, 5th floor, practice of medicine department
PG Division, 5th floor, practice of medicine department
Navsari
GUJARAT
396445
India |
| Phone |
9687544985 |
| Fax |
|
| Email |
sanghanich@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ramesh kumar gupta |
| Designation |
Professor of practice of medicine department |
| Affiliation |
S. S. Agrawal Homoeopathic Medical College And General Hospital, Navsari |
| Address |
PG Division, 5th floor, practice of medicine department
PG Division, 5th floor, practice of medicine department
Navsari
GUJARAT
396445
India |
| Phone |
9867412109 |
| Fax |
|
| Email |
drrameshgupta794@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Ramesh kumar gupta |
| Designation |
Professor of practice of medicine department |
| Affiliation |
S. S. Agrawal Homoeopathic Medical College And General Hospital, Navsari |
| Address |
PG Division, 5th floor, practice of medicine department
PG Division, 5th floor, practice of medicine department
Navsari
GUJARAT
396445
India |
| Phone |
9867412109 |
| Fax |
|
| Email |
drrameshgupta794@gmail.com |
|
|
Source of Monetary or Material Support
|
| S. S. Agrawal Homoeopathic Medical College And General Hospital, PG Division, 5th floor, practice of medicine department, Near devina park society, gandevi road, Navsari - 396445, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
S. S. Agrawal Homoeopathic Medical College And General Hospital, Navsari |
| Address |
near devina park society, gandevi road, navsari, Gujarat, 396445 |
| 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 |
| Sanghani chandni harsukhbhai |
S. S. Agrawal Homoeopathic Medical College and General Hospital |
Research OPD, Ground floor, Near devina park society, gandevi road, navsari, Gujarat 396445
Navsari
GUJARAT |
9687544985
sanghanich@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institution ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicines for Diabetes Mellitus Type 2 |
It will be based on constitutional approach and on the repertorial totality |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed T2DM, HbA1c 6.5-10%, 30-65 years and of both sexes will be included in this study |
|
| ExclusionCriteria |
| Details |
Type 1 DM, pregnant women, insulin users, severe
complications along T2DM like nephropathy and HTN will be excluded in this study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in FBS and PPBS, HbA1c levels after giving constitutional medicine (0, 3, 6, 12 months) |
9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| changes in Homoeopathic symptom severity score |
12 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
09/09/2025 |
| 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="1"
Months="0"
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 prospective study involving patients of Diabetes Mellitus Type 2 with homoeopathic intervention based on constitutional approach. The study involves 80 participants of age group 30 to 65 years of both the sexes and will be for the duration of 12 months. Improvement will be measured by using T2DM symptom severity scale and clinical assessment by comparing glycemic level (HbA1C), response to homoeopathic treatment before and after treatment. |