| CTRI Number |
CTRI/2025/02/080361 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management of Diabetic Foot Ulcers in LM potency |
|
Scientific Title of Study
|
Role of LM Potency of Homoeopathic Similimum in Management of Diabetic Foot Ulcers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ruzzaim A |
| Designation |
PG Scholar |
| Affiliation |
White memorial homoeo medical college and hospital |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy
White Memorial Homoeopathic Medical College and Hospital
Chevaracode, Attoor, Kanniyakumari-629177
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
7598503795 |
| Fax |
|
| Email |
ruzzaimr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr INDU P |
| Designation |
Head of Department |
| Affiliation |
White memorial homoeo medical college and hospital |
| Address |
Department of Organon of Medicine and Homoeopathic
Philosophy
White Memorial Homoeopathic Medical College and Hospital
hospital, Chevaracode, Attoor, Kanniyakumari-629177
Kanniyakumari
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9495704030 |
| Fax |
|
| Email |
indusujan9495@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ruzzaim A |
| Designation |
PG Scholar |
| Affiliation |
White Memorial Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy
White Memorial Homoeopathic Medical College and Hospital
Chevaracode, Attoor, Kanniyakumari-629177
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
7598503795 |
| Fax |
|
| Email |
ruzzaimr@gmail.com |
|
|
Source of Monetary or Material Support
|
| White Memorial Homoeopathic Medical College and Hospital Chevaracode Attoor
Kanniyakumari 629177 |
|
|
Primary Sponsor
|
| Name |
White Memorial Homoeopathic Medical College and Hospital |
| Address |
White Memorial Homoeopathic Medical College and Hospital
Chevaracode Attoor Kanniyakumari 629177 |
| 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 Ruzzaim A |
White Memorial Homoeopathic Medical College and Hospital |
White Memorial
Homoeopathic Medical
Hospital IPD OPD of
Department of
Organon of Medicine and
Homoeopathic
Philosophy
Chevaracode Attoor
Kanniyakumari 629177
Kanniyakumari
TAMIL NADU |
7598503795
ruzzaimr@gmail.com |
|
|
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, (2) ICD-10 Condition: E111||Type 2 diabetes mellitus with ketoacidosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
lm potency |
water dose in hundred ml frequent repitation six times per day oral
administation of medicine |
| Comparator Agent |
NIL |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Both sexes
Age of the patient above Forty years
Patient diagnosed with type 2 diabetes mellitus with presence of atleast one foot ulcer classified under wagner grade 1 to 3
Willingness to participate and provide informed consent
|
|
| ExclusionCriteria |
| Details |
Patients who undergone any amputation surgical procedures
Patients with gestational diabetes
Patient with severe extensive ulceration ie Patient with grade 4 or above according to meggitt wagner classification
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pre and Post Assessment of HBA1C
RBS and FBS of the Patient |
1 Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Meggitt Wagner Scale |
1 Year |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
22/02/2025 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 15-03-2027 and end date provided 15-03-2032?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
Role of lm potency of homoeopathic similimum in management of diabetic foot ulcers Diabetic foot ulcers is a significance and complex complication of diabetes primarily resulting from neuropathy and peripheral artery disease fifty millesimal potencies have got great advantages like possibility of frequent repetition least aggravation which could be very much admissible for hypersensitive persons least quantity of material doses which is basic for prescriptions and above all it help to hasten cure with very rare occurance of aggravation patient with both sexes age group of forty to seventy five patient diagnosed with type two diabetes mellitus with presents of atleast one foot ulcer classified under wagnar grade one to three cases are taken from white memorial homoeo medical college and hospital pre and post treatment of fasting blood sugar random blood sugar and glycated haemoglobin |