| CTRI Number |
CTRI/2026/01/101448 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
17/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on the Effectiveness of Homeopathic Remedies Selected from Repertories in the Treatment of Diabetic Foot Ulcer |
|
Scientific Title of Study
|
Effectiveness of rubrics related to foot ulcers from Homeopathic Repertories in treatment of Diabetic Foot Ulcers |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hema Suresh |
| Designation |
Research Scholar |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
Room no. 301, IInd Floor, college building, Department of Repertory, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9443460783 |
| Fax |
|
| Email |
drhemasureshmd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A S Suman Sankar |
| Designation |
Professor |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
Room no. 301, IInd Floor, college building, Department of Repertory, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9443500675 |
| Fax |
|
| Email |
dissert02@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A S Suman Sankar |
| Designation |
Professor |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
Room no. 301, IInd Floor, college building, Department of Repertory, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9443500675 |
| Fax |
|
| Email |
dissert02@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institution -Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari District, Tamil Nadu, India 629161 |
|
|
Primary Sponsor
|
| Name |
PhD Research Funded by the Institution |
| Address |
Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari District, Tamil Nadu, India 629161 |
| 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 Hema Suresh |
Sarada Krishna Homoeopathic Medical College Hospital |
Room No 107, Department of Repertory,Ground Floor,Hospital building, Sarada Krishna Homoeopathic Medical College Hospital, Kulasekharam, Kanniyakumari District, Tamil Nadu, India 629161
Kanniyakumari
TAMIL NADU |
9443460783
drhemasureshmd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee Sarada Krishna Homoeopathic Medical College |
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 |
Homoeopathic Medicine for varicose ulcer selected after Repertorisation |
30C potency daily at night orally. Repetition and change in potency will be selected after assessing the improvement during the follow -up. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
- Diagnosed Insulin - dependent or non - insulin dependent Diabetes Mellitus.
- Patients presenting with ulcer on the lower extremity for more than 1 Week.
- Patients taking Allopathic medications on which they are dependent.
- During the study the patients area allowed to continue Anti- hypertensive and/ or Statin drugs. |
|
| ExclusionCriteria |
| Details |
- Cases presenting with gangrene or impending gangrene
- Ulcers with underlying osteomyelitis
- Venous ulcers or ulcers due to any other cause.
- Cases diagnosed with Malignancies.
- Cases presenting with a long term complication of Diabetes.
- Patients requiring intravenous antibiotics, emergency management or surgical intervention.
- Patients suffering life - threatening or chronic diseases like IHD of less than 6 months duration, Unstable angina, Hypertension, Malignancy or HIV/AIDS etc.
- History of Coma. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
- Decline of clinical symptoms.
- Wound healing
- Comparison of change in size of wound area
- Complete closure or epithelisation |
3 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- Clinical Course of Diabetic Foot Ulcer during Homoeopathic treatment in terms of ulcer characteristics and individual symptoms.
- To identify the additional clinical symptoms (provings) of the Homoeopathic medicines used during the study.
- Observation on changes in characteristic rubrics used for medicine selection after treatment |
3 Months |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/01/2026 |
| 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="2"
Months="0"
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
|
This study aims to evaluate the effectiveness of homoeopathic medicines
selected using predefined foot-ulcer-related rubrics from various repertories
in the treatment of Diabetic Foot Ulcers (DFU). Forty DFU patients (Wagner
grade 1–3, age 18–80) who meet the inclusion criteria and do not present
gangrene, osteomyelitis, malignancy, severe systemic diabetic complications, or
life-threatening illness will be enrolled. The primary objective is to assess
the usefulness of selected rubrics in identifying the simillimum, while
secondary objectives include evaluating clinical improvement, wound-healing
progress, and changes in characteristic rubrics during treatment. Interventions
include detailed case-taking, repertorial analysis using standard repertories,
individualized homoeopathic prescription as per Organon guidelines. Outcomes
will be measured using the Bates–Jensen Wound Assessment Tool, and changes in
wound size, appearance, symptoms, and overall healing response. The study
expects to document clinical efficacy of rubric-based homoeopathic management
and identify characteristic ulcer features guiding remedy selection in DFU. |