| CTRI Number |
CTRI/2024/06/069164 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
17/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management of Cutaneous Warts with Homoeopathic medicines |
|
Scientific Title of Study
|
A Clinical study on Management of Cutaneous Warts with Homoeopathic Medicines in 50 Millesimal Potencies |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Preethi James P |
| Designation |
Pg Scholar |
| Affiliation |
DR MGR Medical University Chennai ,White Memorial Homoeo Medical College and Hospital |
| Address |
Department of Materia Medica
White Memorial Homoeo Medical College and Hospital
Attoor, Veeyannoor PO
Kanniyakumari
Tamilnadu
Tamilnadu - 629177
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
7708626518 |
| Fax |
|
| Email |
preethijamesp22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasobh M P |
| Designation |
Associate Professor |
| Affiliation |
White Memorial Homoeo Medical College and Hospital |
| Address |
Department of Materia Medica
White Memorial Homoeo Medical College and Hospital
Attoor, Veeyannoor PO
Kanniyakumari
Tamilnadu - 629177
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9447746688 |
| Fax |
|
| Email |
drprasobhmp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Preethi James P |
| Designation |
Pg Scholar |
| Affiliation |
White Memorial Homoeo Medical College and Hospital |
| Address |
Department of Materia Medica
White Memorial Homoeo Medical College and Hospital
Attoor, Veeyannoor PO
Kanniyakumari
Tamilnadu -629177
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
7708626518 |
| Fax |
|
| Email |
preethijamesp22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Materia Medica
White Memorial Homoeo Medical College and Hospital
Attoor,Veeyannoor PO
kanniyakumari
Tamilnadu 629117 |
|
|
Primary Sponsor
|
| Name |
White Memorial Homoeo medical College and hospital |
| Address |
White Memorial Homoeo medical College and hospital, Attoor,
Veeyannoor PO, kanniyakumari
Tamilnadu 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 Preethi James P |
White Memorial Homoeo Medical College and hospital |
Department of Materia Medica
White Memorial Homoeo medical College and hospital,
Attoor, Veeyannoor PO
Veeyannoor
Kanniyakumari
Tamilnadu
Kanniyakumari
TAMIL NADU |
7708626518
preethijamesp22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee White Memorial Homoeo Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B079||Viral wart, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homeopathic medicines in 50 millesimal potencies |
Individualized Homeopathic medicines in 50 millesimal potencies will be administered to the patient in proper dose, potency and repitation of medicine according to Homeopathic principles.All the individuals in the study are given medicine. Each case will be reviewed after 15 days interval or as per need in case of emergency and followed up for maximum of 6 months.Assessment of the case will be done using Cutaneous warts Diagnostic tool at the last. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are diagnosed with cutaneous warts.
Subject of both sexes.
Age group from 18 to 60 years |
|
| ExclusionCriteria |
| Details |
Patient with Ano genital warts.
Pregnant and lactating wonen.
Individuals already under treatment (Medicinal/surgical/both) within 1 month for cutaneous warts.
Immunocompromised patients.
Case with HIV and Cancerous manifestation. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reducing the size of warts. |
After 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| After completion of study follow up & assessment of size of warts will be done |
Maximum of 6 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 2 |
|
Date of First Enrollment (India)
|
28/06/2024 |
| 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
|
A minimum of 50 cases will be selected for the study by purposive sampling. Cases will be taken in detail and recorded in the structured case sheet formulated for the study. Diagnosis will be done by clinical presentation and examination. Assessment is done using Cutaneous wart diagnostic tool. In each case, medicines will be selected after taking the detailed case history and performing analysis, evaluation, and repertorization. Medicines are differentiated using various Materia medica. A single homoeopathic medicine in 50 millesimal potency is prescribed as per the law ofhomeopathy. Follow up will be done once in 15 days and further treatment was proceed accordingly based on existing symptoms. Results will be assessed by pre and post |