Efficacy and Safety of Jiuweihuaban Pill for Treating Plaque Psoriasis

Официальное название

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 ).

Обзор

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

Вмешательства

• Препарат Jiuweihuaban Pill placebo
  Jiuweihuaban pill placebo 1 bag(12 g placebo per bag),p.o.,tid,for 12weeks.
• Препарат 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.
• Препарат high dose Jiuweihuaban Pill
  High dose Jiuweihuaban pill 1 bag(12 g Jiuweihuaban pill ),p.o.,tid,for 12weeks.

Первичные конечные точки

• PASI 75 [Срок оценки: Baseline to days 84.]

Вторичные конечные точки (11)

• PASI75 [Срок оценки: Baseline to days 28、56.]
• PASI50、90 [Срок оценки: Baseline to days 28、56、84.]
• Change value and percentage change in PASI score [Срок оценки: Baseline to days 84.]
• Proportion of subjects achieving sPGA=0 or 1 [Срок оценки: Baseline to days 28、56、84.]
• Proportion of subjects achieving an improvement of ≥2 points in sPGA [Срок оценки: Baseline to days 28、56、84.]
• Change value and percentage change in BSA affected by psoriasis [Срок оценки: Baseline to days 28、56、84.]
• Change value and percentage change in NRS for skin itching [Срок оценки: Baseline to days 28、56、84.]
• Change value and percentage change in DLQI score [Срок оценки: Baseline to days 28、56、84.]
• Proportion of subjects achieving DLQI=0-1 [Срок оценки: Baseline to days 28、56、84.]
• Change value and percentage change in Traditional Chinese Medicine Syndrome score [Срок оценки: Baseline to days 28、56、84.]
• Disappearance rate of individual symptoms in Traditional Chinese Medicine Syndrome [Срок оценки: Baseline to days 28、56、84.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.
• Systemic therapy with non-biological drugs within 4 weeks prior to randomization, including but not limited to systemic corticosteroids, retinoids, methotrexate, and cyclosporine.
• 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.
• Topical anti-psoriatic treatment received within 2 weeks prior to randomization, including retinoids, vitamin D3 derivatives, corticosteroids, and others
• Physical therapy received within the 4 weeks prior to randomization, including phototherapy (such as UVB, PUVA), combination phototherapy, and balneotherapy.
• 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.
• 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.
• 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.
• Participation in other clinical trials and received investigational drugs within 1 month prior to screening.
• Patients with hypersensitivity to the investigational drug components.
• Patients had a history of smoking, alcohol, drug abuse.
• 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
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 12 центров

• Beijing traditional Chinese medicine hospital affiliated to Capital Medical University — Пекин
• Affiliated Hospital of Changchun University of Traditional Chinese Medicine — Changchun
• The First Affiliated Hospital of Hunan University of Chinese Medicine — Чанша
• Chengdu Second People's Hospital — Чэнду
• Affiliated Hospital of Shandong University of Traditional Chinese Medicine — Цзинань
• Yunnan Provincial Hospital of Traditional Chinese Medicine — Куньмин
• Nanyang First People's Hospital — Nanyang
• The First Affiliated Hospital of China Medical University — Шэньян
• … и ещё 4 центра

Идентификаторы

NCT: NCT06058546 · TSL-TCM-JWHBW-II

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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