Protocol summary

Summary
The clinical and therapeutic benefit of this topical formulation with 10% Verbascum thapsus was carried out on 25 patients with mild to moderate atopic dermitit in a double-blind, placebo-controlled clinical trial on comparison to corresponding vehichel (placebo) and investigated the clinical changes in patients who completed the study. The Verbascum thapsus ointment was applied to one side of each patient's body and the vehicle to the opposite side twice daily for 8 weeks.in the first and after two months being photographed by specialist redness-dryness-itching and scaling is reported.it is necessary to mention at this time no other medication in this area not be used.

General information

Acronym
effect of extract ointment Verbascum thapsus on patients with atopic darmitit
IRCT registration information
IRCT registration number: IRCT201404073106N15
Registration date: 2014-06-02, 1393/03/12
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-06-02, 1393/03/12
Registrant information
Name
Farshad Hashemian
Name of organization / entity
Pharmaceutical Sciences Branch, Islamic Azad University (IAU)
Country
Iran (Islamic Republic of)
Phone
+98 21 2260 0037
Email address
hashemian.f@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
1- Pharmaceutical Sciences branch of Islamic Azad University, 2- investigators financial sources
Expected recruitment start date
2014-04-09, 1393/01/20
Expected recruitment end date
2014-06-10, 1393/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of extract ointment Verbascum thapsus on patients with atopic darmitit Investigation effect of verbascum ointment on eczema patients Investigation effect of verbascum ointment on eczema patients
Public title
effect of extract ointment Verbascum thapsus on patients with atopic darmitit
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : 1-age of 18 & older male & female , 2-discontinued of topical treatment 2weeks . 3- existence of any infection or tumor . Exclusion criteria: 1-pregnancy, 2- lactation, 3-under 18
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 25
Randomization (investigator's opinion)
Not 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
Pharmaceutical science branch of Islamic Azad
Street address
No.99, Yakhchal street, Dr. Shariati Avenue
City
Tehran
Postal code
Approval date
2014-04-06, 1393/01/17
Ethics committee reference number
57

Health conditions studied

1

Description of health condition studied
Atopic dermitit
ICD-10 code
L20.0
ICD-10 code description
Besnier's prurigo

Primary outcomes

1

Description
Erythema dryness itching
Timepoint
At the end each 2 weeks to 8 weeks
Method of measurement
Photography: before, during & after treatment

Secondary outcomes

1

Description
side effects
Timepoint
At the end each 2 weeks up to 8 weeks
Method of measurement
Questionnaire, photography, scoring

Intervention groups

1

Description
Herbal ointment: containing 10 % Verbascum thapsus extract in plastibase. patients were instructed to apply the Herbal ointment twice a day.
Category
Treatment - Drugs

2

Description
Placebo ointment: containing plastibase. Patients were instructed to apply twice a day.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam khomaini hospital
Full name of responsible person
Dr. Parvin Mansouri
Street address
Keshavarz blv, Imam Khomeini Hospial complex
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Pharmaceutical science branch of Islamic Azad university
Full name of responsible person
Dr. Orkideh Ghorban dadras
Street address
No.99, Yakhchal street, Dr. Shariati Avenue Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pharmaceutical science branch of Islamic 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Pharmaceutical science branch of Islamic azad
Full name of responsible person
Dr. Farshad Hashemian
Position
Assistant professor / Head of Department
Other areas of specialty/work
Street address
No.99, Yakhchal street, Dr. Shariati Avenue
City
Tehran
Postal code
Phone
00
Fax
Email
hashemian.f@iaups.ac.ir
Web page address

Person responsible for updating data

Contact

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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