Efficacy and Safety of Jiuweihuaban Pill for Treating Plaque Psoriasis

Launched by TASLY PHARMACEUTICAL GROUP CO., LTD · Sep 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a new treatment called Jiuweihuaban Pill for people with moderate to severe plaque psoriasis, a skin condition that causes red, scaly patches. The trial is currently recruiting participants aged 18 to 65 who have been diagnosed with this type of psoriasis and meet certain criteria, such as having specific levels of skin involvement and symptoms. Participants must be willing to provide informed consent and be in good overall health, meaning they should not have other serious health issues or recent treatments that could interfere with the study.

If you choose to participate, you will be part of a research study that aims to find out if Jiuweihuaban Pill can help improve your psoriasis. Throughout the trial, you can expect regular check-ins and evaluations to monitor your progress and any side effects. It's important to note that certain individuals, such as those with specific types of psoriasis or those on certain medications recently, may not be eligible to participate. If you’re interested, be sure to discuss it with your healthcare provider to see if it might be a good option for you.

Gender

ALL

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.