Protocol summary

Summary
Psoriasis is an inflammatory disorder formed by inappropriate interaction of T lymphocytes with keratinocytes and consequent eruption of immune responses which leads to keratinocytes hyper-proliferation and epidermis thickening and scaling. TNF-α is known to be a key cytokine in psoriasis pathogenic process. Hypericum perforatum is known to have both anti-inflammatory and anti-proliferative properties and has been reported to be clinically helpful in management of psoriatic lesions. A randomized, double-blind, placebo-controlled study of topical hypericum perforatum was conducted on 40 patients with mild to moderate plaque type psoriasis. Hypericum perforatum ointment was applied to one side of the body and placebo ointment to the other side twice daily for 4 consecutive weeks. Modified psoriasis area severity index (PASI) scores and histological and clinical changes were investigated after topical application of hypericum perforatum and compared with placebo application. Moreover, TNF-α level in tissue samples were measured with immunohistochemistry method.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201503173106N24
Registration date: 2015-05-03, 1394/02/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-05-03, 1394/02/13
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
Islamic Azad University, Pharmaceutical Sciences Branch (IAUPS)
Expected recruitment start date
2011-02-17, 1389/11/28
Expected recruitment end date
2015-05-05, 1394/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of TNFα Levels in Psoriatic Plaque Tissue after topical St Johns Wort (Hypericum perforatum L) Application in Patients with Plaque Type Psoriasis vulgaris
Public title
The Effects of Topical St Johns Wort Application in Patients with Plaque Type Psoriasis vulgaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with the age between 18 to 50 years old; diagnosis of mild to moderate plaque type psoriasis on both sides of the body; not being under medical treatment for the past two months. Exclusion criteria: pregnancy; lactation; suffering from a major illness (such as cardiovascular disease, acute renal or liver disease, cancer or active malignancy); not having plaque psoriasis on both sides of the body.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad University, Pharmaceutical Sciences Branch (IAUPS)
Street address
No.99 Yakhchal Street, Shariati Avenue, 1941933111, Tehran, Iran.
City
Tehran
Postal code
1941933111
Approval date
2010-09-27, 1389/07/05
Ethics committee reference number
7173

Health conditions studied

1

Description of health condition studied
Plaque Psoriasis
ICD-10 code
L40.0
ICD-10 code description
Psoriasis vulgaris

Primary outcomes

1

Description
Erythema, Thickness, Scaling
Timepoint
At the end of week 4
Method of measurement
Modified psoriasis area severity index (PASI) scores

2

Description
Tissue TNFα Level
Timepoint
At the end of Week 4
Method of measurement
Mouse anti-human TNFα (28401.111) monoclonal antibody

Secondary outcomes

1

Description
Side effects
Timepoint
At the end of week 4
Method of measurement
Questionnaire, Photography, Scoring

Intervention groups

1

Description
Herbal ointment containing 5% Hypericum perfuratum extract in Vaseline base was used on lesions of one side of the body twice daily.
Category
Treatment - Drugs

2

Description
Placebo ointment in Vaseline base was used on the lesions of the other side of the body twice daily.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini 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
Islamic Azad University, Pharmaceutical Sciences Branch
Full name of responsible person
Dr. Farshad Hashemian
Street address
No. 99, Yakhchal Street, Shariati Avenue.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Pharmaceutical Sciences Branch
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
Islamic Azad University, Pharmaceutical Sciences Branch, Faculty of Pharmacy
Full name of responsible person
Dr. Farshad Hashemian
Position
Dean of School of Pharmacy, Associate Professor/ Pharm.D., Pharmacotherapy Specialist
Other areas of specialty/work
Street address
No.99, Yakhchal St., Shariati Ave.
City
Tehran
Postal code
1941933111
Phone
+98 21 2264 0056
Fax
Email
hashemian.f@iaups.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University, Pharmaceutical Sciences Branch, Faculty of Pharmacy (IAUPS)
Full name of responsible person
Dr. Farshad Hashemian
Position
Dean of School of Pharmacy, Associate Professor/ Pharm.D., Pharmacotherapy Specialist
Other areas of specialty/work
Street address
No. 99 Yakhchal Street, Shariati Avenue.
City
Tehran
Postal code
1941933111
Phone
+98 21 2264 0056
Fax
Email
hashemian.f@iaups.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University, Pharmaceutical Sciences Branch, Faculty of Pharmacy
Full name of responsible person
Dr. Elnaz Roohi
Position
Pharm.D.
Other areas of specialty/work
Street address
No. 99, Yakhchal Street, Shariati Avenue.
City
Tehran
Postal code
Phone
+98 21 2264 0056
Fax
Email
eroohi@yahoo.com
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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