Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
NCT06058546

Efficacy and Safety of Jiuweihuaban Pill for Treating Plaque Psoriasis

Led by Tasly Pharmaceutical Group Co., Ltd · Updated on 2024-09-03

180

Participants Needed

12

Research Sites

96 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study will evaluate the efficacy and safety of Jiuweihuaban Pill in the treatment of moderate to severe plaque psoriasis(syndrome of blood-heat ).

CONDITIONS

Official Title

Efficacy and Safety of Jiuweihuaban Pill for Treating Plaque Psoriasis

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 65 years, male or female
  • Diagnosed with plaque psoriasis vulgaris according to western criteria
  • Meets Traditional Chinese Medicine syndrome standards for blood-heat plaque psoriasis
  • At screening: PASI score between 3 and 20, Body Surface Area (BSA) affected between 3% and 10%, and sPGA score of 2 or higher
  • Willing to participate voluntarily and sign informed consent
Not Eligible

You will not qualify if you...

  • Psoriasis caused by drugs or non-plaque types such as guttate, arthropathic, pustular, erythrodermic, or lesions only in specific areas like face, scalp, nails, or mucous membranes
  • Systemic non-biological therapy within 4 weeks before randomization
  • Systemic biological therapy within 12 weeks or 5 half-lives before randomization
  • Topical anti-psoriatic treatment within 2 weeks before randomization
  • Physical therapy like phototherapy within 4 weeks before randomization
  • Systemic anti-infective treatment within 4 weeks before randomization or active infections
  • Serious, progressive, or uncontrolled diseases including immune, endocrine, hematological, urinary, liver, respiratory, nervous, psychiatric, cardiovascular, gastrointestinal, infectious diseases, or cancer
  • Elevated serum creatinine or liver enzymes above specified limits at screening
  • Participation in other clinical trials or use of investigational drugs within 1 month before screening
  • Hypersensitivity to study drug components
  • History of smoking, alcohol, or drug abuse
  • Plans for pregnancy from 2 weeks before first dose to 1 month after last dose without effective contraception
  • Other conditions deemed unsuitable by the investigator such as other skin problems, compliance issues, or inability to complete study requirements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 12 locations

1

Beijing traditional Chinese medicine hospital affiliated to Capital Medical University

Beijing, China

Actively Recruiting

2

Affiliated Hospital of Changchun University of Traditional Chinese Medicine

Changchun, China

Actively Recruiting

3

The First Affiliated Hospital of Hunan University of Chinese Medicine

Changsha, China

Actively Recruiting

4

Chengdu Second People's Hospital

Chengdu, China

Actively Recruiting

5

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Jinan, China

Actively Recruiting

6

Yunnan Provincial Hospital of Traditional Chinese Medicine

Kunming, China

Actively Recruiting

7

Nanyang First People's Hospital

Nanyang, China

Actively Recruiting

8

The First Affiliated Hospital of China Medical University

Shenyang, China

Actively Recruiting

9

Affiliated Hospital of Tianjin Institute of Traditional Chinese Medicine

Tianjin, China

Actively Recruiting

10

First affiliated hospital of Wenzhou medical university

Wenzhou, China

Actively Recruiting

11

The Second Affiliated Hospital of Xiamen Medical College

Xiamen, China

Actively Recruiting

12

Xingtai people's hospital

Xingtai, China

Actively Recruiting

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Research Team

R

Rui Liu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Efficacy and Safety of Jiuweihuaban Pill for Treating Plaque Psoriasis | DecenTrialz