| CTRI Number |
CTRI/2025/02/081407 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Role of Homoeopathic medicines in post leprosy ulcers. |
|
Scientific Title of Study
|
Comparative efficacy of Individualized Homoeopathic Medicine vs Merc sol 200 in Post Leprosy Ulcers- Randomized, Single- Blind trial |
| 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 Renu Mittal |
| Designation |
Research Officer Homoeopathy |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room No 304, Department: Scheduled Caste Sub plan.
61 65 Institutional Area, opposite D block, New Delhi
South West
DELHI
110058
India |
| Phone |
9717511115 |
| Fax |
|
| Email |
renumittal08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Taneja |
| Designation |
Research Officer Homoeopathy |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room No 309, Department: Public Health.
61 65 Institutional Area, opposite D block, New Delhi
South West
DELHI
110058
India |
| Phone |
9810305068 |
| Fax |
|
| Email |
drdivyataneja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Taneja |
| Designation |
Research Officer Homoeopathy |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room No 309, Department: Public Health.
61 65 Institutional Area, opposite D block, New Delhi
DELHI
110058
India |
| Phone |
9810305068 |
| Fax |
|
| Email |
drdivyataneja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy, 61-65 institutional area, opposite D block, Janakpuri, New Delhi, India, Pin code- 110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy, Jawahar Lal Nehru Chikitsa Avum Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block Janakpuri |
| Type of Sponsor |
Research institution |
|
|
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 Vishal Chadha |
Sarvodya Kushth Ashram |
Tahirpur, East Delhi-110095
East
DELHI |
9818345704
drvishalchadha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B92||Sequelae of leprosy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic medicines |
Group I: Individualized homoeopathic medicines obtained after case taking will be prescribed via oral route of administration for duration of 12 months |
| Comparator Agent |
Merc sol 200 |
Merc sol 200/ One dose weekly will be given to the participant |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Any gender aged between 18 years and 60 years.
Patients will be enrolled in the study after a minimum of 1 month of completion of treatment (i.e. MDT of at least 6 months for pauci-bacillary Those who have post-leprosy ulcers, anywhere in the body.
|
|
| ExclusionCriteria |
| Details |
Patient taking
anticoagulant/antithrombotic/immunosuppressive drugs. Patients with self reported patient history of bleeding disorder, pregnant and lactating women, Self-reported chronic alcoholism, Patients with uncontrolled diabetes,peripheral neuropathy due to other than leprosy such as nerve injury, history of spina bifida, Patients on steroid treatment for reaction or neuritis or within 03 months after steroid treatment, having alcoholic neuropathy, polyneuropathy,varicose veins, vascular diseases and arteriosclerosis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of individualized homoeopathic medicines vs. Merc sol 200 in Post Leprosy Ulcers |
Assessed monthly till end of 12 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the change in number, location, depth and size of the Post Leprosy ulcers.
To assess the changes in the sensory functions of the area adjacent to the Post Leprosy ulcers.
To assess the changes in Braden scoring scale for Post Leprosy ulcers.
|
Assessed monthly till end of 12 months |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
03/03/2025 |
| 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="3"
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
|
This Randomized comparative study compares the efficacy of Individualized Homoeopathic Medicine vs Merc sol 200 in Post Leprosy Ulcers. The objective of the study is to evaluate the effectiveness of individualized homoeopathic medicines vs Merc sol 200 in Post leprosy ulcers to assess the change in number, location, depth, and size of the Post leprosy ulcers, to assess the changes in the sensory functions of the area adjacent to the Post leprosy ulcer to determine the changes in the Braden scoring scale for Post leprosy ulcers.
|