Efficacy and Safety of Jiuweihuaban Pill for Treating Plaque Psoriasis
ConditionPlaque Psoriasis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTasly Pharmaceutical Group Co., Ltd
About this trial
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
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Jiuweihuaban Pill placebo
- low dose Jiuweihuaban Pill
- high dose Jiuweihuaban Pill
Treatment groups
180 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov