| CTRI Number |
CTRI/2025/08/093094 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
14/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
HOMOEOPATHIC MANAGEMENT OF TYPE 2 DIABETES MELLITUS |
|
Scientific Title of Study
|
A CLINICAL STUDY ON THE EFFECT OF HOMOEOPATHIC MEDICAL REPERTORY ON HbA1c LEVELS IN TYPE-II 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 |
Dr RAM SUNDHAR M |
| Designation |
POST GRADUATE |
| Affiliation |
SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
ROOM NO 301 2nd FLOOR DEPARTMENT OF HOMOEOPATHIC REPERTORY AND CASE TAKING
SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL
KULASEKHARAM KANNIYAKUMARI TAMIL NADU 629161
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
8667638513 |
| Fax |
|
| Email |
mramsundhar2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SATHISH KUMAR V |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
ROOM NO 301 2nd FLOOR DEPARTMENT OF HOMOEOPATHIC REPERTORY AND CASE TAKING
SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL
KULASEKHARAM KANNIYAKUMARI TAMIL NADU 629161
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9443558483 |
| Fax |
|
| Email |
hodcr@skhmc.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr SATHISH KUMAR V |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
ROOM NO 301 2nd FLOOR DEPARTMENT OF HOMOEOPATHIC REPERTORY AND CASE TAKING
SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL
KULASEKHARAM KANNIYAKUMARI TAMIL NADU 629161
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9443558483 |
| Fax |
|
| Email |
hodcr@skhmc.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
POST GRADUATE DISSERTATION |
| Address |
SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL KULASEKHARAM KANNIYAKUMARI TAMIL NADU 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 SATHISH KUMAR V |
SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
ROOM NO 103 GROUND FLOOR
SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL
KULASEKHARAM KANNIYAKUMARI TAMIL NADU 629161
Kanniyakumari
TAMIL NADU |
9443558483
hodcr@skhmc.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
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 MEDICINES |
CONSTITUTIONAL MEDICINES WILL BE ADMINISTERED ORALLY SINGLE DOSE AT A TIME.
MEDICINES WILL BE REPEATED ONCE IN 2 WEEKS FOR 3 MONTHS |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient within age group of 30-70 years
Both sexes
HbA1c level above 6.2 percentage will be tested
Cases that are diagnosed as Diabetes Mellitus
Patients with complications of Diabetes mellitus which includes Diabetic foot ulcer Diabetic neuropathy diabetic nephropathy and diabetic retinopathy
|
|
| ExclusionCriteria |
| Details |
Patients before 30 years and after 70 years
Patients with surgical complications
Patients with juvenile and gestational diabetes
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of HbA1c level after the administration of Homoeopathic medicines will be done
This study will help in assessing the importance and reliability of Homoeopathic Medical Repertory in managing patients with Diabetes mellitus
|
Once in 3 months HbA1c value will be assessed |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of improvement in diabetic clinical score during the follow up will be done |
Once in 3 months HbA1c value will be assessed |
|
|
Target Sample Size
|
Total Sample Size="27"
Sample Size from India="27"
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)
|
30/08/2025 |
| 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
|
Diabetes can be treated with various system of medicines and Homoeopathy plays an important role in treating Diabetes especially with constitutional method of treatment. Homoeopathy is also used as a complementary therapy to support the well being of the patient and helps in the improvement of symptoms like tiredness, neuropathy, nephropathy or stress which can affect the blood sugar control. There are so many repertories available in the field of Homoeopathy but still, a need is felt among the physicians to find out more useful repertory in cases of diabetes mellitus. Among the various repertories, Homeopathic Medical Repertory by Robin Murphy, contains every detail from all the existing repertories & upgradation from various sources. The aim is to assess the effectiveness of Homoeopathic Medical Repertory as a tool in improving the HbA1c value and in managing type-II diabetes mellitus. The objective is to assess the level of HbA1c value in Type-II Diabetic patients and to study the usefulness of Homoeopathic Medical Repertory in managing Type-II Diabetes mellitus. A sample of 27 cases will be taken from the patients who have been pre-diagnosed with Diabetes mellitus visiting the OPD, and peripheral centers of Sarada Krishna Homoeopathic Medical College and Hospital for homoeopathic treatment will be randomly assigned in the study. The sample size is 27 Cases and the period of study is 1 Year. The Expected duration of the subject participation is 6 Months. The outcome is to find the improvement using Homoeopathic Medical Repertory in Type-II DM, to show improvement in the symptoms of Diabetes mellitus and the Cases will be evaluated for age, sex, occupation, symptoms presented, values of HbA1c levels and will be considered for statistical analysis and to derive the result, thereby validating the study. |