| CTRI Number |
CTRI/2026/03/106217 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
10/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study To Find Out The Effect Of Individualized Homeopathic Treatment In Patients With Type 2 Diabetes mellitus |
|
Scientific Title of Study
|
AN INTERVENTIONAL STUDY TO ASSESS THE EFFECTIVENESS OF INDIVIDUALIZED HOMOEOPATHIC MEDICINE IN THE MANAGEMENT OF TYPE 2 DIABETES MELLITUS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NILL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kapil Raman |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Homoeopathy Delhi |
| Address |
Department of Practice of Medicine , National Institute Of Homoeopathy Delhi
North West
DELHI
110040
India |
| Phone |
9654856771 |
| Fax |
|
| Email |
kapilraman37@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nabanita Debnath |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Homoeopathy Delhi |
| Address |
Department of Practice of Medicine , National Institute Of Homoeopathy Delhi
North West
DELHI
10040
India |
| Phone |
7002819571 |
| Fax |
|
| Email |
juidebnath90@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nabanita Debnath |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Homoeopathy Delhi |
| Address |
Department of Practice of Medicine , National Institute Of Homoeopathy Delhi
North West
DELHI
10040
India |
| Phone |
7002819571 |
| Fax |
|
| Email |
juidebnath90@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Practice Of Medicine National Institute Of Homoeopathy Delhi Sector A8 Chaudhary Ramdev Chowk Narela Delhi India 110040 |
|
|
Primary Sponsor
|
| Name |
National Institute of Delhi |
| Address |
Department Of Practice Of Medicine OPD No 124 National Institute Of Homoeopathy Delhi Sector A8 Chaudhary Ramdev Chowk Narela Delhi India 110040 |
| 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 Kapil Raman |
National Institute Of Homoeopathy Delhi |
Department Of Practice of Medicine OPD No 124 National Institute Of Homoeopathy Delhi sector A8 Chaudhary Ramdev Chowk Narela Delhi 110040
North West
DELHI |
09654856771
kapilraman37@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional 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 |
Individualised Medicine |
Individualized Homoeopathic Medicine Will Be Prescribed Based On A Detailed Case Taking Process Which Shall Be Done In Accordance With The Direction Laid Down By Dr. C. F. S. Hahnemann In The Organon Of Medicine. Medicine Selection, Potency Selection, Dose, Repetition, And Follow Up Shall Be Done On The Basis Of Instructions Given By Dr Hahnemann In The Organon Of Medicine. Homoeopathic Medicine shall be given orally in the form of globules of 40 numbers. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Newly diagnosed cases Diagnosed Type 2 Diabetes Mellitus who have a Blood FBS More than 126mg/dl upto 200mg/dl & Post prandial plasma glucose 200-300 mg/dl.
Newly diagnosed cases Diagnosed Type 2 Diabetes Mellitus who have a HbA1C 6.5-8.5
Willing patients who will give their written consent for the study.
|
|
| ExclusionCriteria |
| Details |
Patients with Type 1 diabetes and complications of type 2 diabetes mellitus .Pregnant or lactating women. Patients with serious systemic disorders or life-threatening infections e.g CKD, CAD.
Patients who are taking medicine from other system.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Fasting Blood Sugar levels and Post-Prandial Blood Sugar |
Baseline and at 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Glycated Hemoglobin (HbA1c) levels, Change in Diabetes Quality of Life (DQOL) score and Assessment using MONARCH (Modified Naranjo Criteria for Homeopathy) score |
Baseline and at 3 months. |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
21/03/2026 |
| 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="6"
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
|
ype 2 Diabetes Mellitus T2DM is a chronic metabolic disorder characterized by persistent hyperglycaemia due to insulin resistance and progressive beta cell dysfunction. The global prevalence of diabetes is increasing rapidly and poses a major public health challenge due to its long term complications affecting the eyes kidneys nerves and cardiovascular system. Homoeopathy follows a holistic and individualized approach in which medicines are prescribed based on the totality of symptoms of the patient. The present study aims to evaluate the effect of individualized homoeopathic treatment in patients with Type 2 Diabetes Mellitus. This will be a single arm interventional clinical study conducted at the National Institute of Homoeopathy Narela. A total of 38 newly diagnosed patients aged 35 to 65 years will receive individualized homoeopathic medicines along with dietary and lifestyle advice. Outcomes will be assessed by comparing fasting blood sugar FBS post prandial blood sugar PPBS HbA1c and Diabetes Quality of Life DQOL scores at baseline and after three months of treatment. Statistical analysis will be performed to evaluate changes in glycaemic control following treatment. |