Efficacy and Safety of Jiuweihuaban Pill for Treating Plaque Psoriasis

Last updated: August 29, 2024
Sponsor: Tasly Pharmaceutical Group Co., Ltd
Overall Status: Active - Recruiting

Phase

2

Condition

Rosacea

Warts

Skin Wounds

Treatment

low dose Jiuweihuaban Pill

Jiuweihuaban Pill placebo

high dose Jiuweihuaban Pill

Clinical Study ID

NCT06058546
TSL-TCM-JWHBW-II
  • Ages 18-65
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Aged 18-65, male or female.

  2. The diagnosis of plaque psoriasis vulgaris was in accordance with the westerndiagnostic criteria

  3. Conformed to the TCM syndrome differentiation standard of plaque psoriasis withBlood-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

Exclusion Criteria:

  1. Psoriasis caused by drug-induced factors; combined with non-plaque Psoriasis atscreening (such as guttate,arthropathica, pustular, erythrodermic and other types ofPsoriasis); The skin lesions are exclusively observed in subjects with specificareas 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, andcyclosporine.

  3. Systemic therapy with biological drugs within 12 weeks or 5 half-lives (whichever islonger) prior to randomization, including but not limited to interleukin antibodies (such as ustekinumab, secukinumab) and tumor necrosis factor-alpha antagonists (suchas 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, includingphototherapy (such as UVB, PUVA), combination phototherapy, and balneotherapy.

  6. Systemic anti-infective treatment received within the 4 weeks prior torandomization; presence of recurrent, chronic, or active infection at baseline asdetermined by the investigator and judged to increase the subject's risk.

  7. With a serious, progressive, or uncontrolled disease, including but not limited to adisease of the immune (such as rheumatoid arthritis, systemic lupus erythematosus,and inflammatory bowel disease), endocrine, hematological, urinary, hepatobiliary,and respiratory, nervous, psychiatric, cardiovascular, gastrointestinal, orinfectious system, a malignancy.

  8. Patients with serum creatinine above the upper limit of normal at screening, withelevated 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 1month 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 thefirst dose to 1 month after the last dose and Subjects do not take effectivecontraceptive measures during this period or during pregnancy or breastfeeding

  13. Any other situation that the investigator did not consider suitable forparticipation in the study, such as other skin problems that hinder the assessmentof Psoriasis, potential compliance problems, inability to complete all examinationsand evaluations in accordance with the protocol requirements, may pose anuncontrollable risk for participation in the study.

Study Design

Total Participants: 180
Treatment Group(s): 3
Primary Treatment: low dose Jiuweihuaban Pill
Phase: 2
Study Start date:
November 23, 2023
Estimated Completion Date:
October 31, 2025

Connect with a study center

  • Beijing traditional Chinese medicine hospital affiliated to Capital Medical University

    Beijing,
    China

    Active - Recruiting

  • Affiliated Hospital of Changchun University of Traditional Chinese Medicine

    Changchun,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Hunan University of Chinese Medicine

    Changsha,
    China

    Active - Recruiting

  • Chengdu Second People's Hospital

    Chengdu,
    China

    Active - Recruiting

  • Affiliated Hospital of Shandong University of Traditional Chinese Medicine

    Jinan,
    China

    Active - Recruiting

  • Yunnan Provincial Hospital of Traditional Chinese Medicine

    Kunming,
    China

    Active - Recruiting

  • Nanyang First People's Hospital

    Nanyang,
    China

    Active - Recruiting

  • The First Affiliated Hospital of China Medical University

    Shenyang,
    China

    Active - Recruiting

  • Affiliated Hospital of Tianjin Institute of Traditional Chinese Medicine

    Tianjin,
    China

    Active - Recruiting

  • First affiliated hospital of Wenzhou medical university

    Wenzhou,
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Xiamen Medical College

    Xiamen,
    China

    Active - Recruiting

  • Xingtai people's hospital

    Xingtai,
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.