Efficacy and Safety of Jiuweihuaban Pill for Treating Plaque Psoriasis
NCT ID: NCT06058546
Last Updated: 2024-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
180 participants
INTERVENTIONAL
2023-11-23
2025-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo group
Jiuweihuaban Pill placebo, 1 bag each time, p.o. , tid
Jiuweihuaban Pill placebo
Jiuweihuaban pill placebo 1 bag(12 g placebo per bag),p.o.,tid,for 12weeks.
Low dose group
Jiuweihuaban Pill , 1 bag each time, p.o. , tid
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.
High dose group
Jiuweihuaban Pill , 1 bag each time, p.o. , tid
high dose Jiuweihuaban Pill
High dose Jiuweihuaban pill 1 bag(12 g Jiuweihuaban pill ),p.o.,tid,for 12weeks.
Interventions
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Jiuweihuaban Pill placebo
Jiuweihuaban pill placebo 1 bag(12 g placebo per bag),p.o.,tid,for 12weeks.
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.
high dose Jiuweihuaban Pill
High dose Jiuweihuaban pill 1 bag(12 g Jiuweihuaban pill ),p.o.,tid,for 12weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Tasly Pharmaceutical Group Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Beijing traditional Chinese medicine hospital affiliated to Capital Medical University
Beijing, , China
Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Changchun, , China
The First Affiliated Hospital of Hunan University of Chinese Medicine
Changsha, , China
Chengdu Second People's Hospital
Chengdu, , China
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, , China
Yunnan Provincial Hospital of Traditional Chinese Medicine
Kunming, , China
Nanyang First People's Hospital
Nanyang, , China
The First Affiliated Hospital of China Medical University
Shenyang, , China
Affiliated Hospital of Tianjin Institute of Traditional Chinese Medicine
Tianjin, , China
First affiliated hospital of Wenzhou medical university
Wenzhou, , China
The Second Affiliated Hospital of Xiamen Medical College
Xiamen, , China
Xingtai people's hospital
Xingtai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TSL-TCM-JWHBW-II
Identifier Type: -
Identifier Source: org_study_id
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