| CTRI Number |
CTRI/2025/09/095140 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
11/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathy in the treatment of warts |
|
Scientific Title of Study
|
Efficacy Of Individualized Homoeopathy In The Treatment Of Warts: A Double Blind, Randomized, Placebo Controlled 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)/ Scientist IV |
| Affiliation |
Central Council for Research in Homeopathy |
| Address |
Room no. 304, Central Council for Research in Homoeopathy,
61-65,Jawahar Lal Nehru Chikitsa Avum Anusandhan Bhawan, Institutional Area, Opposite D Block
Janakpuri, New Delhi, India
South West DELHI 110058 India |
| Phone |
9717511115 |
| Fax |
|
| Email |
renumittal8@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Renu Mittal |
| Designation |
Research Officer (Homoeopathy)/ Scientist IV |
| Affiliation |
Central Council for Research in Homeopathy |
| Address |
Room no. 304, Central Council for Research in Homoeopathy,
61-65,Jawahar Lal Nehru Chikitsa Avum Anusandhan Bhawan, Institutional Area, Opposite D Block
Janakpuri, New Delhi, India
South West DELHI 110058 India |
| Phone |
9717511115 |
| Fax |
|
| Email |
renumittal8@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Divya Taneja |
| Designation |
Research Officer (Homoeopathy)/ Scientist III |
| Affiliation |
Central Council for Research in Homeopathy |
| Address |
Room no. 309, Central Council for Research in Homoeopathy, 61-65, Jawahar Lal Nehru Chikitsa Avum Anusandhan Bhawan, Institutional Area, Opposite D Block
Janakpuri, New Delhi, India
South West DELHI 110058 India |
| Phone |
9810305068 |
| Fax |
|
| Email |
drdivyataneja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council For Research In Homoeopathy |
|
|
Primary Sponsor
|
| Name |
Central Council For Research In Homoeopathy |
| Address |
61-65,Jawahar Lal Nehru Chikitsa Avum Anusandhan Bhawan, Institutional Area, Opposite D Block, Janak Puri, New Delhi, India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nidhi Mahajan |
Central Research Institute (H), Jaipur |
Department of Clinical Research, OPD No 6, Sector 26, Pratap Nagar, Jaipur- 302033, Rajasthan Jaipur RAJASTHAN |
9119124757
drnidhimahajan1@gmail.com |
| Dr Renu Bala |
Clinical Research Institute for Homoeopathy, Lucknow |
Department of Clinical Research, OPD No 4, Campus of National Homoeopathic Medical College & Hospital, 1, Viraj Khand, Gomti Nagar, Lucknow- 226010, Uttar Pradesh Lucknow UTTAR PRADESH |
9140570079
drrenu3011@gmail.com |
| Dr James Michael |
Clinical Research Unit (H), Aizawl |
Department of Clinical Research, OPD No 4, 3rd Floor, Ayush OPD Building, Block-D, Civil Hospital, Dawrpui, Aizawl-796001, Mizoram Aizawl MIZORAM |
9958994325
jamesmichael312@gmail.com |
| Dr Santosh Tamang |
Clinical Research Unit (H), Gangtok |
Department of Clinical Research, OPD No 3, Development Area, Near Sangram Bhawan Indira Byepass, Gangtok- 737102 East SIKKIM |
8250332201
crugangtok@gmail.com |
| Dr Hiren Natvarlal |
Clinical Research Unit (H), Puducherry |
Department of Clinical Research, OPD No 2, 14, 6th Cross, Jawahar Nagar, Puducherry- 605005, Tamilnadu Pondicherry PONDICHERRY |
7396561012
dr.hirenkamalia@gmail.com |
| Dr G R C Reddy |
Clinical Research Unit (H), Tirupati |
Department of Clinical Research, OPD No 2, Srabanam Campus, Old Maternity Hospital Campus, Tirupati- 517507, Andhra Pradesh Chittoor ANDHRA PRADESH |
9441208007
dr.grcreddy@gmail.com |
| Dr D Kartikeyan |
Homoeopathy Research Institute for Disabilities, Chennai |
Department of Clinical Research, Room No- 136, NIEPMD Campus, ECR, Muttukadu, Chennai- 603112, Tamilnadu Chennai TAMIL NADU |
8281488685
drkarthikeyanmd@gmail.com |
| Dr Ranjit Sonny |
Regional Research Institute (H), Siliguri |
Department of Clinical Research, OPD No 1, Siliguri-734012 Darjiling WEST BENGAL |
9883202281
rrih-siliguri@ccrhindia.nic.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Central Ethics Committee |
Approved |
| Central Ethics Committee |
Approved |
| IEC, CRI(H), JAIPUR |
Approved |
| IEC, CRI(H), LUCKNOW |
Approved |
| IEC, CRU(H), PUDUCHERRY |
Approved |
| IEC, CRU(H), TIRUPATI |
Approved |
| IEC, RRI(H), AGARTALA |
Approved |
| IEC, RRI(H), Guwahati |
Approved |
| IEC, RRI(H), SILIGURI |
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 |
Indicated Homoeopathic medicine |
Indicated homoeopathic medicine based on individualized symptom totality in compliance with pharmacopoeial standards from GMP compliant manufacturers would only be used. The medicines would be taken orally in form of pills (sugar globules) of standard size 30, saturated with homoeopathic dilutions for 6 months
No new drug will be used.
|
| Comparator Agent |
Placebo |
Identical placebo saturated with 83.1% v/v ethyl alcohol would be used for 6 months. The placebo will also be dispensed in sugar globules of standard size 30 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All types of cutaneous warts
Single wart sized equal or more than 2 mm/ multiple warts wherein at least one wart should be equal or more than 2 mm |
|
| ExclusionCriteria |
| Details |
Anogenital warts, Bowenoidpapulosis, focal epithelial hyperplasia or seborrhoric keratosis.
History of skin cancer
Treatment with immune-modulating oral medications like corticosteroids in past 04 weeks
Patient on homoeopathic treatment for any disease condition.
Self-reporting cases of HIV
Pregnant and lactating women
Advance disease of any vital organs
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Percentage of warts disappeared
Regression in the Size and number of warts (in millimeter scale) |
At baseline, 15 days, 1 month, 1.5 months, 2 months, 2.5 months, 3 months, 3.5 months, 4 months, 4.5 months, 5 months, 5.5 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Dermatological life quality index (DLQI) questionnaire score |
Baseline, at the end of 1 month, 3rd month and 6th month |
| Identification of specific HPV genotypes in patients suffering from warts on a sample of patients |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="310" Sample Size from India="310"
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 |
|
Date of First Enrollment (India)
|
15/10/2025 |
| 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="2" 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 is a multicentric, Randomized, double blind, placebo controlled study which will be undertaken in the special dermatology clinics operating in the research centers of the Council. The dermatology clinics are managed by trained homoeopathic practitioners with research experience. The clinics provide routine OPD care to patients suffering from dermatological disorders using homoeopathic medicines only. The primary objective is to evaluate response to individualized homoeopathic treatment for disappearance or resolution of warts and secondary objective is to assess and compare the effect of homoeopathic medicine in warts on the basis of Dermatological life quality index (DLQI) questionnaire score and to identify specific HPV genotypes and their correlation with homoeopathic treatment outcomes on a sample of patients. The participants aged 18 to 65 years, both gender will be enrolled under the study. All types of cutaneous warts, single or multiple wherein one wart should be atleast more or equal to 2 mm will be included under the study. The outcome assessment will be done on the basis of percentage of warts disappeared, regression in the size and number of warts (in millimeter scale) to be assessed on fortnightly basis and change in the dermatological life quality index score at baseline, at the end of 1 month, 3rd month and 6th month. |