A Randomized, Double-blind, Placebo-controlled, Multi-center Phase II Clinical Trial of Efficacy and Safety of Jiuweihuaban Pill in the Treatment of Moderate to Severe Plaque Psoriasis(Syndrome of Blood-heat ).
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This study will evaluate the efficacy and safety of Jiuweihuaban Pill in the treatment of moderate to severe plaque psoriasis(syndrome of blood-heat ).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Aged 18-65, male or female.
• The diagnosis of plaque psoriasis vulgaris was in accordance with the western diagnostic criteria
• Conformed to the TCM syndrome differentiation standard of plaque psoriasis with Blood-heat syndrome.
• At screening period: 3 ≤PASI≤ 20, 3%≤BSA≤ 10% and sPGA≥2.
• Willing to participate voluntarily and sign a written informed consent.
Locations
Other Locations
China
Beijing traditional Chinese medicine hospital affiliated to Capital Medical University
RECRUITING
Beijing
Affiliated Hospital of Changchun University of Traditional Chinese Medicine
RECRUITING
Changchun
The First Affiliated Hospital of Hunan University of Chinese Medicine
RECRUITING
Changsha
Chengdu Second People's Hospital
RECRUITING
Chengdu
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
RECRUITING
Jinan
Yunnan Provincial Hospital of Traditional Chinese Medicine
RECRUITING
Kunming
Nanyang First People's Hospital
RECRUITING
Nanyang
The First Affiliated Hospital of China Medical University
RECRUITING
Shenyang
Affiliated Hospital of Tianjin Institute of Traditional Chinese Medicine
RECRUITING
Tianjin
First affiliated hospital of Wenzhou medical university
RECRUITING
Wenzhou
The Second Affiliated Hospital of Xiamen Medical College
RECRUITING
Xiamen
Xingtai people's hospital
RECRUITING
Xingtai
Contact Information
Primary
Rui Liu
liurui2@tasly.com
022-86343626
Time Frame
Start Date: 2023-11-23
Estimated Completion Date: 2025-10
Participants
Target number of participants: 180
Treatments
Placebo_comparator: Placebo group
Jiuweihuaban Pill placebo, 1 bag each time, p.o. , tid
Experimental: Low dose group
Jiuweihuaban Pill , 1 bag each time, p.o. , tid
Experimental: High dose group
Jiuweihuaban Pill , 1 bag each time, p.o. , tid
Related Therapeutic Areas
Sponsors
Leads: Tasly Pharmaceutical Group Co., Ltd