Study Evaluating the Efficacy and Safety of Triptergium Wilfordii and Acitretin in Psoriasis Vulgaris - CHINA201002016-2

NCT ID: NCT01443338

Last Updated: 2011-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

720 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Brief Summary

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The purpose of this study is to determine whether Triptergium wilfordii, and Acitretin are effective and safe in the treatment of patient of moderate to severe psoriasis vulgaris.

Detailed Description

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Conditions

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Psoriasis Vulgaris

Keywords

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Triptergium wilfordii Acitretin psoriasis vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Triptergium Wilfordii

a kind of traditional chinese medicine

Group Type ACTIVE_COMPARATOR

Triptergium Wilfordii

Intervention Type DRUG

Tablet,10mg/Tab,20mg Tid,No more than 8 Weeks

Acitretin

Group Type ACTIVE_COMPARATOR

Acitretin

Intervention Type DRUG

Capsule,10mg/Cap,30mg Qd,no more than 8 weeks

Interventions

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Triptergium Wilfordii

Tablet,10mg/Tab,20mg Tid,No more than 8 Weeks

Intervention Type DRUG

Acitretin

Capsule,10mg/Cap,30mg Qd,no more than 8 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adults of both sexes, between the age 18 and 75 years.
* Have a diagnosis of psoriasis vulgaris,PASI score of 7 or greater.
* Capable of giving informed consent and the consent must be obtained prior to any study related procedures.

Exclusion Criteria

* Currently have erythrodermic,guttate or pustular psoriasis.
* Have any active dermatoses which may affect disease assessment of psoriasis.
* Have used any investigational drug,any biologic or any systemic immunosuppressants within the previous 1 month..
* Have used topical medications/treatments that could affect psoriasis or PASI evaluation (eg, corticosteroids, tar, phototherapy et al.) within 2 weeks.
* Have any acute or chronic or recurrent infectious disease,which was difficult to control.
* Have the history of HBV or HCV infection,or HIV antibody test positive.
* AST, ALT or blood fat levels must be within 1.5 times the ULN range for the laboratory conducting the test.
* Are pregnant, nursing, or planning pregnancy in the coming two years(both men and women) while enrolled in the study.
* Have any severe systemic disease or have a history of malignancy.
* Have shown a previous hypersensitivity to Triptergium wilfordii or Acitretin.
* Have any other condition not suitable to join in trial,which are judged by investigator.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, China

OTHER_GOV

Sponsor Role lead

Responsible Party

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Min Zheng

Head of dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lunfei Liu, Dr

Role: CONTACT

Phone: 86-571-87783743

Email: [email protected]

Jisu Chen, Dr

Role: CONTACT

Phone: 86-571-87783743

Email: [email protected]

Facility Contacts

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Lunfei Liu, Md

Role: primary

Jisu Chen, MD

Role: backup

Other Identifiers

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CHINA201002016-2

Identifier Type: -

Identifier Source: org_study_id