Study Evaluating the Efficacy and Safety of Triptergium Wilfordii and Acitretin in Psoriasis Vulgaris - CHINA201002016-2
This study is currently recruiting participants.
Verified September 2011 by Ministry of Health, China
Sponsor:
Ministry of Health, China
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriasis Vulgaris |
Drug: Triptergium Wilfordii Drug: Acitretin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Ministry of Health, China:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 720 |
| Study Start Date: | September 2011 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Triptergium Wilfordii
a kind of traditional chinese medicine
|
Drug: Triptergium Wilfordii
Tablet,10mg/Tab,20mg Tid,No more than 8 Weeks
|
| Active Comparator: Acitretin |
Drug: Acitretin
Capsule,10mg/Cap,30mg Qd,no more than 8 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01443338
Contacts
| Contact: Lunfei Liu, Dr | 86-571-87783743 | liulunfei@medmail.com.cn |
| Contact: Jisu Chen, Dr | 86-571-87783743 | cgmcjs@msn.com |
Locations
| China, Zhejiang | |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting |
| Hangzhou, Zhejiang, China, 310009 | |
| Contact: Lunfei Liu, Md 86-571-87783743 liulunfei@medmail.com.cn | |
| Contact: Jisu Chen, MD 86-571-87783743 cgmcjs@msn.com | |
| Principal Investigator: Min Zheng, PHD&MD | |
| Sub-Investigator: Lunfei Liu, MD | |
| Sub-Investigator: JIsu Chen, MD | |
| Sub-Investigator: Jianliang Yan, MD | |
| Sub-Investigator: Jianyou Wang, MD | |
Sponsors and Collaborators
Ministry of Health, China
More Information
No publications provided
| Responsible Party: | Min Zheng, Head of dermatology, Second Affiliated Hospital, School of Medicine, Zhejiang University |
| ClinicalTrials.gov Identifier: | NCT01443338 History of Changes |
| Other Study ID Numbers: | CHINA201002016-2 |
| Study First Received: | September 26, 2011 |
| Last Updated: | September 28, 2011 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Ministry of Health, China:
|
Triptergium wilfordii Acitretin psoriasis vulgaris |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Acitretin |
Keratolytic Agents Dermatologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013