| CTRI Number |
CTRI/2018/05/013908 [Registered on: 16/05/2018] Trial Registered Prospectively |
| Last Modified On: |
08/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To the study the role of vitamin D3 injection for treating cutaneous warts |
|
Scientific Title of Study
|
Role of intralesional vitamin D3 injection in the treatment of cutaneous 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 Shrini Parikh |
| Designation |
first year post graduate resident |
| Affiliation |
Peoples college of medical sciences and research centre |
| Address |
Peoples college of medical sciences and research centre Bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9098281100 |
| Fax |
|
| Email |
shrini.parikh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek Kumar Dey |
| Designation |
Professor and HOD |
| Affiliation |
Peoples college of medical sciences and reseach centre |
| Address |
Peoples college of medical sciences and research centre Bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9981346039 |
| Fax |
|
| Email |
drvivekdey@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vivek Kumar Dey |
| Designation |
Professor and HOD |
| Affiliation |
Peoples college of medical sciences and reseach centre |
| Address |
Peoples college of medical sciences and research centre Bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9981346039 |
| Fax |
|
| Email |
drvivekdey@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Dr. Shrini Parikh
Peoples college of medical sciences and research centre Bhopal |
|
|
Primary Sponsor
|
| Name |
Dr Shrini Parikh |
| Address |
Peoples college of medical science and research centre |
| Type of Sponsor |
Other [Self] |
|
|
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 Shrini Parikh |
Peoples college of medical sciences and research centre |
OPD no 8 department of dermatology room number 1
Bhopal
MADHYA PRADESH |
90982821100
shrini.parikh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy human volunteers having cutaneous warts |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Vitamin D3 |
0.2-0.5ml of intralesional vitamin D3 to be injected in warts depending on the size and number of warts(maximum 5 warts i.e. maximum 1ml of vitamin D3) per sitting for a maximum of 4 sittings at 2 weekly intervals |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1 patients having cutaneous warts
2 patients > 18 years
3 patients with no prior treatment with either topical or destructive modalities for atleast 6 months |
|
| ExclusionCriteria |
| Details |
1 patients < 18 years
2 pregnant and lactating females
3 any evidence of immunosuppression including HIV
4 prior history of hypersensitivity to vitamin D3
5 previously diagnosed renal disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| regression of cutaneous warts |
2 weekly intervals for a maximum of 4 sessions |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to prevent recurrence of warts |
for upto 6 months after resolution of warts |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2018 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To study the role of intralesional vitamin D3 injection as an immunotherapeutic agent in treating cutaneous warts which are previously untreated for the past 6 months in > 18 years of patients 0.2-0.5ml of vitamin D3 will be injected in lesions with a 26-gauge insulin syringe depending on the number of warts in maximum of 5 warts. The injections will be performed at 2 weekly intervals for 4 sessions. The patients will be followed up for a period of 6 months to check for recurrence of warts. |