| CTRI Number |
CTRI/2018/12/016672 [Registered on: 14/12/2018] Trial Registered Prospectively |
| Last Modified On: |
07/12/2018 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathy treatment for warts |
|
Scientific Title of Study
|
A Multicentric randomized, double blind, placebo controlled study to evaluate efficacy of predefined homoeopathic medicines in treatment of Warts. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R K Manchanda |
| Designation |
Director General |
| Affiliation |
CCRH |
| Address |
Central Council for Research in Homeopathy,61-65, Institutional Area, Opp.D Block, Janak Puri
South West
DELHI
110058
India |
| Phone |
011-28525523 |
| Fax |
011-28521060 |
| Email |
dgccrh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Khurana |
| Designation |
Deputy Director General |
| Affiliation |
CCRH |
| Address |
Central Council for Research in Homeopathy,61-65, Institutional Area, Opp.D Block, Janak Puri
South West
DELHI
110058
India |
| Phone |
011-28525749 |
| Fax |
011-28521060 |
| Email |
ccrhindia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anil Khurana |
| Designation |
Deputy Director General |
| Affiliation |
CCRH |
| Address |
Central Council for Research in Homeopathy,61-65, Institutional Area, Opp.D Block, Janak Puri
South West
DELHI
110058
India |
| Phone |
011-28525749 |
| Fax |
011-28521060 |
| Email |
ccrhindia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy, 61-65 institutional area D-block Janakpuri, New Delhi 110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy, 61-65, Institutional Area, Opp D-Block, Janakpuri, Delhi South West, Delhi |
| 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 MS Gosh |
Dr. Anjali Chatterjee Regional Research Institute for Homoeopathy, Kolkata |
DR. ANJALI CHATTERJI REGIONAL RESEARCH IN HOMOEOPATHY, 50, RAJENDRA
CHATTERJEE ROAD, KOLKATA-700035
Kolkata
WEST BENGAL |
9874821270
033-281400507
drmsghosh31@gmail.com |
| Dr Padmalya Rath |
Dr. D. P. Rastogi Central Research Institute of Homoeopathy, Noida |
Sector 24, Noida, Uttar Pradesh 201307
Gautam Buddha Nagar
UTTAR PRADESH |
9811704560
0120-2411320
drpadmalya@gmail.com |
| Dr P Hima Bindu |
Princess Durru Shevar Hospital, Ext. center of DrugStandardization Unit, Hyderabad |
Princess Durru Shevar hospital,Hyderabad
Hyderabad
ANDHRA PRADESH |
9490009899
040-24567754
drbindu_hima@yahoo.com |
| Dr Partha Pratim Pal |
Regional Research for Homoeopathy, Agartala |
REGIONAL RESEARCH INSTITUTE FOR HOMOEOPATHY, AGARTALA
Joy Krishna Kobra Para Road, Khumulwng, Jirania,Agartala,
Tripura (W). Pin-799045
West Tripura
TRIPURA |
9774764825
0381-2530077
justdoit.partha@gmail.com |
| Dr BRajshekharan |
Regional Research Institute for Homoeopathy, Gudivada |
Dr. GGH Medical College Campus,Eluru Road,
Gudivada – 521 301
Krishna Dist., Andhra Pradesh State
Krishna
ANDHRA PRADESH |
7207611151
086-74244484
rajasekhar@saimail.com |
| Dr Nidhi Mahajan |
Regional Research Institute Homoeopathy, Jaipur |
Regional Research Institute for Homoeopathy
MPK Homoeo Medical College,
Hospital &Research Centre Campus, Station Road,
Jaipur-302006, Rajasthan
Jaipur
RAJASTHAN |
9119124757
0141-2371763
drnidhimahajan1@gmail.com |
| Dr Vaishali Shinde |
Regional Research Institute Homoeopathy, Navi Mumbai |
REGIONAL RESEARCH INSTITUTE (HOMOEOPATHY),
Hall no. 4, Shopping centre, Sector-9, CBD, Belapur, Navi Mumbai-400614
Mumbai
MAHARASHTRA |
9920425854
022-27577501
drvshsb@gmail.com |
| Dr AK Prushty |
Regional Research Institute Homoeopathy, Puri |
Regional Research Institute (H), Puri
CCRH Building, Marchikote Lane, Puri, Odisha
Puri
ORISSA |
9778461673
06752-225571
prushtyakshayakumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of CCRH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B078||Other viral warts, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Antim crudum,calcarea carbonicum,causticum,dulcamara,natrum muriaticum,nitric acidicum,ruta,sulphur,thuja occidentalis |
These homeopathic medicines are as per Homeopathic Pharmacopoeia of India and will be used in this study.Medicines will be dispensed in sugar globules of size 30. |
| Comparator Agent |
placebo |
The unmedicated sugar globules of size 30 will be used as placebo |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
all types of cutaneous warts |
|
| ExclusionCriteria |
| Details |
1 Anogenital warts
2 plantar warts
3 bowenoid papulosis
4 focal epithelial hyperplasia
5 seborrhoic keratosis
6 H/o skin cancer
7 Treatment with immune modulating oral medications like corticosteroids in past 4 weeks
8 Patient on homoeopathic treatment for any Disease condition
9 Self reporting cases of HIV
10 Pregnant and lactating women
11 Advance diseases of vital organs
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of warts disappeared |
At baseline and fortnightly follow up for 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To validate the symptoms of the pre-defined 09 drugs in warts |
At baseline and fortnightly follow up for 6 months |
|
|
Target Sample Size
|
Total Sample Size="480"
Sample Size from India="480"
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)
|
01/04/2019 |
| 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
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A Double Blind Placebo Controlled Study to evaluate the efficacy in the treatment of Warts using 09 predefined Homoeopathic Medicines is proposed to be conducted at 08 centres. The proposed sample size is 480cases (60 cases per center). The objective of the study is evaluate response to homoeopathic treatment for disappearance or resolution of warts and to validate the symptoms of the pre-identified 09 drugs on the clinical outcome on warts |