Efficacy and Safety of Jiuweihuaban Pill for Treating Plaque Psoriasis

September 27, 2023 updated by: Tasly Pharmaceutical Group Co., Ltd

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 ).

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Beijing traditional Chinese medicine hospital affiliated to Capital Medical University
        • Contact:
      • Changchun, China
        • Affiliated Hospital of Changchun University of Traditional Chinese Medicine
        • Contact:
      • Changsha, China
        • The First Affiliated Hospital of Hunan University of Chinese Medicine
        • Contact:
      • Chengdu, China
      • Jinan, China
        • Affiliated Hospital of Shandong University of Traditional Chinese Medicine
        • Contact:
      • Kunming, China
        • Yunnan Provincial Hospital of Traditional Chinese Medicine
        • Contact:
      • Nanyang, China
        • Nanyang First People's Hospital
        • Contact:
      • Shenyang, China
        • The First Affiliated Hospital of China Medical University
        • Contact:
      • Tianjin, China
        • Affiliated Hospital of Tianjin Institute of Traditional Chinese Medicine
        • Contact:
      • Wenzhou, China
        • First affiliated hospital of Wenzhou medical university
        • Contact:
      • Xiamen, China
        • The Second Affiliated Hospital of Xiamen Medical College
        • Contact:
      • Xingtai, China
        • Xingtai People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged 18-65, male or female.
  2. The diagnosis of plaque psoriasis vulgaris was in accordance with the western diagnostic criteria
  3. Conformed to the TCM syndrome differentiation standard of plaque psoriasis with Blood-heat syndrome.
  4. At screening period: 3 ≤PASI≤ 20, 3%≤BSA≤ 10% and sPGA≥2.
  5. Willing to participate voluntarily and sign a written informed consent.

Exclusion Criteria:

  1. Psoriasis caused by drug-induced factors; combined with non-plaque Psoriasis at screening (such as guttate,arthropathica, pustular, erythrodermic and other types of Psoriasis); The skin lesions are exclusively observed in subjects with specific areas such as the face, scalp, nails, skin folds, glans penis, mucous membranes, palms, and soles.
  2. Systemic therapy with non-biological drugs within 4 weeks prior to randomization, including but not limited to systemic corticosteroids, retinoids, methotrexate, and cyclosporine.
  3. Systemic therapy with biological drugs within 12 weeks or 5 half-lives (whichever is longer) prior to randomization, including but not limited to interleukin antibodies (such as ustekinumab, secukinumab) and tumor necrosis factor-alpha antagonists (such as etanercept, infliximab, adalimumab) in the study.
  4. Topical anti-psoriatic treatment received within 2 weeks prior to randomization, including retinoids, vitamin D3 derivatives, corticosteroids, and others
  5. Physical therapy received within the 4 weeks prior to randomization, including phototherapy (such as UVB, PUVA), combination phototherapy, and balneotherapy.
  6. Systemic anti-infective treatment received within the 4 weeks prior to randomization; presence of recurrent, chronic, or active infection at baseline as determined by the investigator and judged to increase the subject's risk.
  7. With a serious, progressive, or uncontrolled disease, including but not limited to a disease of the immune (such as rheumatoid arthritis, systemic lupus erythematosus, and inflammatory bowel disease), endocrine, hematological, urinary, hepatobiliary, and respiratory, nervous, psychiatric, cardiovascular, gastrointestinal, or infectious system, a malignancy.
  8. Patients with serum creatinine above the upper limit of normal at screening, with elevated Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) levels ≥ 1.5 times the upper limit of normal.
  9. Participation in other clinical trials and received investigational drugs within 1 month prior to screening.
  10. Patients with hypersensitivity to the investigational drug components.
  11. Patients had a history of smoking, alcohol, drug abuse.
  12. Patients (including partners) have plans to become pregnant from 2 weeks before the first dose to 1 month after the last dose and Subjects do not take effective contraceptive measures during this period or during pregnancy or breastfeeding
  13. Any other situation that the investigator did not consider suitable for participation in the study, such as other skin problems that hinder the assessment of Psoriasis, potential compliance problems, inability to complete all examinations and evaluations in accordance with the protocol requirements, may pose an uncontrollable risk for participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo group
Jiuweihuaban Pill placebo, 1 bag each time, p.o. , tid
Drug: Jiuweihuaban Pill placebo
Jiuweihuaban pill placebo 1 bag(12 g placebo per bag),p.o.,tid,for 12weeks.
Other Names:
  • Placebo group
Experimental: Low dose group
Jiuweihuaban Pill , 1 bag each time, p.o. , tid
Drug: low dose Jiuweihuaban Pill
Low dose Jiuweihuaban pill 1 bag(3 g placebo per bag and 9 g Jiuweihuaban pill ),p.o.,tid,for 12weeks.
Other Names:
  • Low dose group
Experimental: High dose group
Jiuweihuaban Pill , 1 bag each time, p.o. , tid
Drug: high dose Jiuweihuaban Pill
High dose Jiuweihuaban pill 1 bag(12 g Jiuweihuaban pill ),p.o.,tid,for 12weeks.
Other Names:
  • High dose group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PASI 75
Time Frame: Baseline to days 84.
Proportion of subjects achieving an improvement of ≥75% in Psoriasis Area and Severity Index (PASI75) from baseline at days84.
Baseline to days 84.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PASI75
Time Frame: Baseline to days 28、56.
Proportion of subjects achieving an improvement of ≥75% in Psoriasis Area and Severity Index (PASI75) from baseline at days 28、56.
Baseline to days 28、56.
PASI50、90
Time Frame: Baseline to days 28、56、84.
Proportion of subjects achieving an improvement of ≥50% and ≥90% in Psoriasis Area and Severity Index (PASI50, PASI90) from baseline at days 28、56、84.
Baseline to days 28、56、84.
Proportion of subjects achieving sPGA=0 or 1
Time Frame: Baseline to days 28、56、84.
Proportion of subjects achieving clear (score of 0) or almost clear (score of 1) in static Physician Global Assessment (sPGA=0 or 1) at Weeks 4, 8, and 12.
Baseline to days 28、56、84.
Proportion of subjects achieving an improvement of ≥2 points in sPGA
Time Frame: Baseline to days 28、56、84.
Proportion of subjects achieving an improvement of ≥2 points in static Physician Global Assessment from baseline at days 28、56、84.
Baseline to days 28、56、84.
Change value and percentage change in BSA affected by psoriasis
Time Frame: Baseline to days 28、56、84.
Change value and percentage change in Body Surface Area (BSA) affected by psoriasis from baseline at days 28、56、84.
Baseline to days 28、56、84.
Disappearance rate of individual symptoms in Traditional Chinese Medicine Syndrome
Time Frame: Baseline to days 28、56、84.
Disappearance rate of individual symptoms in Traditional Chinese Medicine Syndrome at days 28、56、84.
Baseline to days 28、56、84.
Change value and percentage change in PASI score
Time Frame: Baseline to days 84.
Change value and percentage change in PASI score from baseline at days 84.The PASI scores can range from 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0, corresponding to maximal signs of psoriasis.
Baseline to days 84.
Change value and percentage change in NRS for skin itching
Time Frame: Baseline to days 28、56、84.
Change value and percentage change in Numeric Rating Scale (NRS) for skin itching from baseline at days 28、56、84. The NRS scores can range from 0,corresponding to no itching symptom，up to a maximum of 10,corresponing to the most severe itching .
Baseline to days 28、56、84.
Change value and percentage change in DLQI score
Time Frame: Baseline to days 28、56、84.
Change value and percentage change in Dermatology Life Quality Index (DLQI) score from baseline at days 28、56、84. The DLQI scores can range from 0 to 30.The higher the score, the worse the quality of life.
Baseline to days 28、56、84.
Proportion of subjects achieving DLQI=0-1
Time Frame: Baseline to days 28、56、84.
Proportion of subjects achieving a DLQI score of 0-1 (DLQI=0-1) at days 28、56、84.The DLQI scores can range from 0 to 30.The higher the score, the worse the quality of life.
Baseline to days 28、56、84.
Change value and percentage change in Traditional Chinese Medicine Syndrome score
Time Frame: Baseline to days 28、56、84.
Change value and percentage change in Traditional Chinese Medicine Syndrome score from baseline at days 28、56、84.The Traditional Chinese Medicine Syndrome scores can range from 0 to 27.The higher the score, the more severe psoriasis.
Baseline to days 28、56、84.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tasly Pharmaceutical Group Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

September 21, 2023

First Submitted That Met QC Criteria

September 21, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSL-TCM-JWHBW-Ⅲ

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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