| CTRI Number |
CTRI/2022/10/046217 [Registered on: 06/10/2022] Trial Registered Prospectively |
| Last Modified On: |
09/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of effectiveness of injection vitamin D3 with normal saline in patients suffering from warts |
|
Scientific Title of Study
|
Immunotherapy of cutaneous warts: A novel comparative study between intralesional vitamin D3 and normal saline from eastern India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SUDIP MANDAL |
| Designation |
Junior Resident |
| Affiliation |
IPGME&R AND SSKMH |
| Address |
Skin Opd. Ipgme&r and sskmh. 244 Ajc bose road
Kolkata
WEST BENGAL
700020
India |
| Phone |
|
| Fax |
|
| Email |
sudipmandal1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gobinda Chatterjee |
| Designation |
Professor |
| Affiliation |
IPGME&R AND SSKM Hospital |
| Address |
Skin OPD. IPGMER AND SSKMH. 244 AJC BOSE ROAD. KOLKATA
Kolkata
WEST BENGAL
700020
India |
| Phone |
|
| Fax |
|
| Email |
chatterjee.gobinda@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Saubhagya Chowdhury |
| Designation |
Junior Resident |
| Affiliation |
IPGME&R AND SSKM Hospital |
| Address |
Skin OPD, IPGME&R and SSKMH, 244 AJC BOSE ROAD. KOL-700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
|
| Fax |
|
| Email |
saubhagya1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPGME&R and SSKM Hospital
244,AJC Bose Road, Kolkata-700020 |
|
|
Primary Sponsor
|
| Name |
IPGMER and SSKMH |
| Address |
244 AJC BOSE ROAD. KOL-20 |
| 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 |
| Sudip Mandal |
IPGME&R and SSKM HOSPITAL |
Skin OPD. Room no 14
244 ajc bose road
Kol-20
Kolkata
WEST BENGAL |
8334024690
sudipmandal1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&R RESEARCH OVERSIGHT COMMITTEE |
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 |
| Comparator Agent |
Normal Saline |
Intralesional NORMAL SALINE INJECTION dose- 1 ml, freq- monthly, duration - 4 month |
| Intervention |
Vitamin D3 |
Intralesional Vitamin D3 injection dose-1 ml cpntaining 60,000 IU,
Freq- every monthly, Duration- 4 month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients with multiple warts who are willing to participate in the study through an informed consent. |
|
| ExclusionCriteria |
| Details |
Patients with multiple warts not willing to participate in the study.
Patients with single wart.
Pregnant and lactating patients with multiple warts.
Patients with multiple warts but aged <18years.
Immunocompromised patients with multiple warts.
Patients with mucosal, facial or anogenital warts.
Patients with severe cardiac or respiratory comorbidities. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in number and size of the local and distant warts. |
Baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24 week, 28 week, 32 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
25/10/2022 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A DOUBLE BLINDED RANDOMISED CONTROLLED TRIAL TO BE DONE BETWEEN INTRALESIONAL VITAMIN D3 AND NORMAL SALINE IN 25 SUBJECTS IN EACH ARM TO ASSESS THE EFFICACY OF INTRALESIONAL VITAMIN D3 IN MANAGEMENT OF VERRUCA VULGARIS |