NCT06058546 Efficacy and Safety of Jiuweihuaban Pill for Treating Plaque Psoriasis
| NCT ID | NCT06058546 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Tasly Pharmaceutical Group Co., Ltd |
| Condition | Plaque Psoriasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2023-11-23 |
| Primary Completion | 2025-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 180 participants in total. It began in 2023-11-23 with a primary completion date of 2025-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06058546 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Plaque Psoriasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06058546 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06058546 currently recruiting?
Yes, NCT06058546 is actively recruiting participants. Contact the research team at liurui2@tasly.com for enrollment information.
Where is the NCT06058546 trial being conducted?
This trial is being conducted at Beijing, China, Changchun, China, Changsha, China, Chengdu, China and 8 additional locations.
Who is sponsoring the NCT06058546 clinical trial?
NCT06058546 is sponsored by Tasly Pharmaceutical Group Co., Ltd. The trial plans to enroll 180 participants.
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