| CTRI Number |
CTRI/2025/11/097574 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
17/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of synthesis repertory in cases of type 2 diabetes mellitus |
|
Scientific Title of Study
|
Application of prescribed medicine from rubrics of Synthesis Repertory in cases of type 2 diabetes mellitus assessed by HbA1c with adjuvant therapy in age group of 30to 60 years a Randomised single blind placebo controlled 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 Kinnari Patel |
| Designation |
Pg scholar |
| Affiliation |
Smt A J SAVLA HOMEOPATHIC COLLEGE MEHSANA |
| Address |
Room No 6 Department Of Medicine Ground Floor Smt AJ Savla Homoeopathic Medical College And Research Institute Pushpanjli Building Near District Session Court Mahesana Gujarat
384001 India
Mahesana
GUJARAT
384001
India |
| Phone |
6351973895 |
| Fax |
|
| Email |
kinnari4871@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Malay Joshi |
| Designation |
Assitant Professor |
| Affiliation |
Smt A J SAVLA HOMEOPATHIC COLLEGE MEHSANA |
| Address |
PG Department of Repertory Smt A J Savla Homoeopathic Medical
College and Research Institute Pushpanjali building Near districtsession court Mehsana Gujarat
384001
India
Mahesana
GUJARAT
384001
India |
| Phone |
9428000782 |
| Fax |
|
| Email |
shckalol@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kinnari Ptael |
| Designation |
PG Scholar |
| Affiliation |
Smt AJ Savla Homoeopathic Medical College And Research Institute |
| Address |
Room No 6 Department OfMedicine Ground Floor Smt AJ Savla Homoeopathic Medical College And Research Institute Pushpanjli Building Near District Session Court Mahesana Gujarat
Mahesana
GUJARAT
384001
Mahesana
GUJARAT
384001
India |
| Phone |
6351973895 |
| Fax |
|
| Email |
kinnari4871@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt A J Savla Homoeopathic Medical college and research institute Pushpanjali building Near district session court Mehsana Gujarat India 384001 |
|
|
Primary Sponsor
|
| Name |
Dr Kinnari Patel |
| Address |
Room No 6 Department Of Medicine Ground Floor Smt. AJ Savla Homoeopathic Medical College And Research Institute Pushpanjli Building Near District Session Court Mahesana Gujarat india 384001
|
| Type of Sponsor |
Other [self] |
|
|
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 kinnari Patel |
Smt A J Savla Homoeopathic Medical College and Research Institute |
Room Number6 department of Medicine ground FloorPushpanjali building Near
district session court Mehsana Gujarat
Mahesana
GUJARAT
Mahesana
GUJARAT |
6351973895
kinnari4871@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Smt A J Savla Homeopathic Medical College institution Ethical committee |
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 |
Individualized Homeopathic Medicine |
Potency Various such as
Decimal Centesimal
50Millesimal etc Doses as per
need of cases Medicines will be
dispensed as per the potency
Frequency as per need of cases
Route of administration Oral
Duration of therapy upto 9months as per need of case
|
| Comparator Agent |
Placebo |
Placebo Administration |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient of type 2 diabetes mellitus having HbA1c level 6.5% to 9%.
2.Patients who are taking oral antihyperglycemic medication.
|
|
| ExclusionCriteria |
| Details |
1.Type 2 diabetes mellitus with complication macrovascular and microvascular..
2.Pregnant women and lactating women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Type 2 Diabetes Mellitus assessment by using HBA1c Report. |
HbA1c reports will be assessed from baseline, 3 months, 6 months,9
months, and at the end of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/12/2025 |
| 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="6"
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 study is a prospective
randomized single-blind placebo-controlled true experimental study to assess
the clinical utility of prescribed medicine from rubrics of Synthesis Repertory
in the management of Type 2 Diabetes Mellitus. The assessment will be done
using HbA1c levels as an objective parameter along with adjuvant therapy. A
total of 40 participants (20 in each group) in the age group of 30–60 years
will be selected according to specific inclusion and exclusion criteria from
the outpatient department. The duration of assessment will be 9 months, and
outcomes will be evaluated based on the reduction in HbA1c levels at baseline
and at the end of the treatment period.
|