| CTRI Number |
CTRI/2025/11/097640 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
17/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of homoeopathic medicines in the treatment of warts on skin
|
|
Scientific Title of Study
|
Effect of Individualized Homoeopathic medicine in the Treatment of Cutaneous Warts using Synthesis Repertory:An Open Label Prospective Clinical Study |
| 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 Monika Somashekar |
| Designation |
PGT Trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD Room No 10,Department of Repertory,National Institute of Homoeopathy,Block GE,Sector 3,Salt Lake,Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
7013416270 |
| Fax |
|
| Email |
monikasomashekar33@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Avijit Shee Burman |
| Designation |
Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD Room No 10,Department of Repertory,National Institute of Homoeopathy,Block GE,Sector 3,Salt Lake,Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
9433392108 |
| Fax |
|
| Email |
asheeburman@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Avijit Shee Burman |
| Designation |
Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD Room No 10,Department of Repertory,National Institute of Homoeopathy,Block GE,Sector 3,Salt Lake,Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
9433392108 |
| Fax |
|
| Email |
asheeburman@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy,Block GE,Sector 3,Salt Lake,Kolkata-700106,West Bengal,India |
| Type of Sponsor |
Government 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 Monika Somashekar |
National Institute Of Homoeopathy |
OPD No 10,Department of Repertory,Block GE,Sector 3,Saltlake,Kolkata
Kolkata
WEST BENGAL |
7013416270
monikasomashekar33@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute Of Homoeopathy Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic medicine |
Indicated individualized homoeopathic medicine will be prescribed after the repertorisation of the case using rubrics within synthesis repertory.Dose,Frequency of the selected medicine will be as per the susceptibility of the case.Follow up will be done monthly till 6 months from the baseline |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from warts diagnosed clinically
Patients having age between 18 to 65 years.
Patients of any sex, all the religions and of different socioeconomic status.
Patients able to read or understand English,hindi,bengali.
Patients willing to take part in the study and for regular follow ups.
|
|
| ExclusionCriteria |
| Details |
Presence of skin diseases that may interfere with assessment like skin tag, moles, dyshidrotic eczema.
Patients having uncontrolled systemic inflammatory medical condition like SLE, RA, Psoriasis
Pregnant and lactating women.
Patients currently undergoing other forms of treatment for warts like allopathic, ayurvedic treatment
Patients having immune compromised condition.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cutaneous Warts(cwarts) diagnostic score |
Baseline and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Collecting Socio demographic data of warts patients & their statistical analysis |
Baseline & 6 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 2 |
|
Date of First Enrollment (India)
|
30/11/2025 |
| 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="6"
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
|
1.Cutaneous warts are benign, spontaneously
regressing, epithelial tumour’s differing in clinical morphology and
histological pattern depending on the inducing human papilloma virus types. 2.Samples will be selected following preliminary and detailed screening using specified selection criteria. 3.Inclusion and exclusion criteria are strictly followed. 4.After consideration of dropout cases, a minimum 40 patients will be enrolled for the study. 5.Case-taking will be done as per the strict homoeopathic principle. 6.Baseline scoring will be taken using CWARTS diagnostic tool. 7.Analysis and evaluation of each case will be done. 8.Miasmatic analysis will be done. 9.Repertorization will be done in Synthesis Repertory. 10.Final selection of the remedy will be done after consultation with Materia Medica. 11.Potency, dose and repetition of the indicated remedies will be guided strictly as per homoeopathic principles. 12.General (non-medicinal) management including appropriate diet and regimen will be advised. 13.Subsequent prescriptions (follow-ups) will be generated according to relevant homoeopathic principles and will be recorded in follow-up sheets. 14.The baseline data will be compared with the data obtained in 6th month. 15.The score obtained by the patients will be compared and result will be analyzed as per appropriate statistical methods and interference will be done thereafter. Powered by |