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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Ministry of Health, China.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Min Zheng, Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT01443338
First received: September 26, 2011
Last updated: September 28, 2011
Last verified: September 2011

September 26, 2011
September 28, 2011
September 2011
December 2012   (final data collection date for primary outcome measure)
Change from baseline in plaque psoriasis as assessed by PASI(psoriasis area and severity index) response or PASI 75 (a patient that has an improvement from baseline PASI of at least 75%) [ Time Frame: to 8 weeks treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01443338 on ClinicalTrials.gov Archive Site
  • Change from baseline in plaque psoriasis as assessed by PASI response or PASI 50 (a patient that has an improvement from baseline PASI of at least 50%) [ Time Frame: to 8 weeks treatment ] [ Designated as safety issue: No ]
  • Change from baseline in plaque psoriasis as assessed by PASI response or PASI 90 (a patient that has an improvement from baseline PASI of at least 90%) [ Time Frame: to 8 weeks treatment ] [ Designated as safety issue: No ]
  • Laboratory parameters, rates of AEs, and percentage of patients requiring interruption or discontinuation of study drug due to AEs [ Time Frame: to 8 weeks treatment ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study Evaluating the Efficacy and Safety of Triptergium Wilfordii and Acitretin in Psoriasis Vulgaris - CHINA201002016-2
A Phase4,Multicenter, Randomized,Double-blind,Double Dummy, Parallel Controlled Study Evaluating the Efficacy and Safety of Triptergium Wilfordii and Acitretin in Treatment of Chinese Patients With Moderate to Severe Psoriasis Vulgaris

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Psoriasis Vulgaris
  • Drug: Triptergium Wilfordii
    Tablet,10mg/Tab,20mg Tid,No more than 8 Weeks
  • Drug: Acitretin
    Capsule,10mg/Cap,30mg Qd,no more than 8 weeks
  • Active Comparator: Triptergium Wilfordii
    a kind of traditional chinese medicine
    Intervention: Drug: Triptergium Wilfordii
  • Active Comparator: Acitretin
    Intervention: Drug: Acitretin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
720
Not Provided
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact: Lunfei Liu, Dr 86-571-87783743 liulunfei@medmail.com.cn
Contact: Jisu Chen, Dr 86-571-87783743 cgmcjs@msn.com
China
 
NCT01443338
CHINA201002016-2
Yes
Min Zheng, Second Affiliated Hospital, School of Medicine, Zhejiang University
Ministry of Health, China
Not Provided
Not Provided
Ministry of Health, China
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP