Protocol summary

Summary
We decided to compare the therapeutic efficacy of Cimetidine and Cryotherapy versus Placebo and Cryotherapy for treatment of warts. Material & methods: Eighty Patients with common wart were randomly allocated in two groups. In the first group Cimetidine was administered, 40 mg/kg daily for three months, also, their warts were freezed monthly for three months. In the second group placebo was administered and their warts were freezed monthly for three month. Recurrence and cure rates for each subject were recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201008134128N2
Registration date: 2010-09-09, 1389/06/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-09-09, 1389/06/18
Registrant information
Name
Majid Rostami
Name of organization / entity
Ardebil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 1224 6687
Email address
m.rostami@arums.ir
Recruitment status
Recruitment complete
Funding source
Ardebil Azad University
Expected recruitment start date
2007-04-21, 1386/02/01
Expected recruitment end date
2008-04-20, 1387/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the therapeutic efficacy of Cimetidine and Cryotherapy in treatment of warts
Public title
Comparison the therapeutic efficacy of Cimetidine and Cryotherapy in treatment of warts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patient with common wart. Exclusion criteria: Raynaud’s Phenomen, peripheral vascular disease, previous wart treatment and cold urticaria.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 81
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ardebil Azad University
Street address
Basij squar
City
Ardebil
Postal code
5615778511
Approval date
empty
Ethics committee reference number
1342

Health conditions studied

1

Description of health condition studied
Diseases of the skin and subcutaneous tissue - Wart
ICD-10 code
B00-B09
ICD-10 code description
Viral infections characterized by skin and mucous membrane lesions

Primary outcomes

1

Description
cilinical improvment
Timepoint
1 month
Method of measurement
cilinical observation

Secondary outcomes

1

Description
Treatment compilications and relapse
Timepoint
Monthly for 3 month
Method of measurement
cilinical observation

Intervention groups

1

Description
First group: Cimetidine, 40 mg/kg daily for three months, also their warts were freezed monthly for three months
Category
Treatment - Drugs

2

Description
Second group: placebo and their warts were freezed monthly for three month
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam hospital
Full name of responsible person
Majid Rostami
Street address
Ardebil Emam hospital
City
Ardebil

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Azad University
Full name of responsible person
Seiied Saeid Hashemein
Street address
Basij square
City
Ardebil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Azad University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Ardebil university of medical sciences
Full name of responsible person
Majid Rostami Mogaddam
Position
Assistant prof., Ardebil university of medical sciences
Other areas of specialty/work
Street address
Ardebil university of medical sciences
City
Ardebil
Postal code
5615778511
Phone
+98 45 1224 6687
Fax
+98 45 1224 6687
Email
m.rostami@arums.ir , drrostami@yahoo.com
Web page address
www.arums.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardebil university of medical sciences
Full name of responsible person
Majid Rostami Mogaddam
Position
Assistant prof., Ardebil university of medical sciences
Other areas of specialty/work
Street address
Ardebil University of Medical Sciences
City
Ardebil
Postal code
5615778511
Phone
+98 45 1224 6687
Fax
+98 45 1224 6687
Email
m.rostami@arums.ir , drrostami@yahoo.com
Web page address
www.arums.ir

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Majid Rostami Mogaddam
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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