Status:
RECRUITING
Efficacy and Safety of Jiuweihuaban Pill for Treating Plaque Psoriasis
Lead Sponsor:
Tasly Pharmaceutical Group Co., Ltd
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06058546
Start Date
November 23 2023
End Date
October 1 2025
Last Update
September 3 2024
Active Locations (12)
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1
Beijing traditional Chinese medicine hospital affiliated to Capital Medical University
Beijing, China
2
Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Changchun, China
3
The First Affiliated Hospital of Hunan University of Chinese Medicine
Changsha, China
4
Chengdu Second People's Hospital
Chengdu, China