| CTRI Number |
CTRI/2026/01/100416 [Registered on: 06/01/2026] Trial Registered Prospectively |
| Last Modified On: |
17/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of individualized homoeopathic medicines in depression in patients with Type 2 diabetes mellitus |
|
Scientific Title of Study
|
A prospective study to assess the effect of individualized homoeopathic intervention in the treatment of depression among patients 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 |
Vimugdha Garg |
| Designation |
PG Scholar |
| Affiliation |
Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute |
| Address |
Sri Ganganagar Homoeopathic Medical College, Hospital and Research Institute, Rajasthan 335002, India, Department of Organon of Medicine and Homoeopathic Philosophy
Ganganagar
RAJASTHAN
335002
India |
| Phone |
8700527084 |
| Fax |
|
| Email |
gargvimugdha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sunil Kumar |
| Designation |
Professor |
| Affiliation |
Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute |
| Address |
Sri Ganganagar Homoeopathic Medical College, Hospital and Research Institute, Rajasthan 335002, India Department of Organon of Medicine and Homoeopathic Philosophy
Ganganagar
RAJASTHAN
335002
India |
| Phone |
9460631084 |
| Fax |
|
| Email |
dr.sunilbishnoi84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vimugdha Garg |
| Designation |
PG Scholar |
| Affiliation |
Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute |
| Address |
Sri Ganganagar Homoeopathic Medical College, Hospital and Research Institute, Rajasthan 335002 India, Department of Organon of Medicine and Homoeopathic Philosophy
Ganganagar
RAJASTHAN
335002
India |
| Phone |
8700527084 |
| Fax |
|
| Email |
gargvimugdha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tantia University, Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute, Rajasthan, 335002, India |
|
|
Primary Sponsor
|
| Name |
Tantia University |
| Address |
Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute, Rajasthan 335002, India, Department of Organon of Medicine and Homoeopathic Philosophy
|
| 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 |
| Dr Vimugdha Garg |
Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute |
Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute, Rajasthan 335002, India, Department of Organon of Medicine and Homoeopathic Philosophy
Ganganagar
RAJASTHAN |
08700527084
gargvimugdha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute, Sri Ganganagar, Rajasthan, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F30-F39||Mood [affective] disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
Individualized homoeopathic medicines will be prescribed based on the totality of symptoms, and the mode of administration will be oral in suitable potency and dosage as per homoeopathic principles. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed/ undiagnosed cases of depression as per the Patient Health Questionnaire (PHQ-9) with Type 2 Diabetes Mellitus, of all age groups, irrespective of their gender.
2. Patients who will give written consent and are willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Patients suffering from severe depression, or other major psychiatric disorders, or with any severe diabetic complications.
2. Pregnant or breastfeeding women.
3. Patients who are not willing to give written consent for the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intensity of depression measured by change in Patient Health Questionnaire-9 (PHQ-9) scores in patients with Type 2 Diabetes Mellitus receiving individualized homeopathic treatment. |
Baseline and during follow-up visits at 3 and 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of the homeopathic miasmatic approach assessed by improvement in clinical symptoms and depression scores. |
Baseline and during follow-up visits at 3 and 6 months. |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
05/02/2026 |
| 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="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
|
Depression is a common psychological disorder marked by persistent low mood,
loss of interest, decreased energy, and impaired functioning in daily life. It can
arise from multiple causes, including biological, psychological, and social factors.
In patients with Type 2 Diabetes Mellitus (T2DM), depression frequently develops
as a comorbid condition due to the chronic nature of the disease, associated
complications, lifestyle limitations, and continuous need for treatment. Depressive symptoms are seen among 30% of Type 2 Diabetes Mellitus patients,
leading to poor treatment adherence and compromised glycemic control. |