Study Protocol
Characteristics of psoriasis vulgaris in China: a prospective cohort study protocol
Abstract
Background: Psoriasis is an incurable, chronic skin disorder with considerable impact on the quality of life. No drugs are available for treating the disease. Clarifying the progression, exploring the risk factors affecting progression, and finding effective treatments with few side-effects and low recurrence rates is critical. This protocol describes a future study that will analyze psoriasis vulgaris progression risk factors and trends, establish a multicenter clinical registration platform, evaluate clinical evidence for Chinese Medicine (CM) intervention for psoriasis, and evaluate therapeutic effectiveness and recurrence rate advantages of CM.
Methods: The study is a prospective cohort clinical trial planned for October 2019 to September 2021 involving 20 clinics. The trial will enroll 1,500 participants in a psoriasis vulgaris group, and 500 healthy participants in a control group (no intervention). The psoriasis vulgaris group will be divided into three equal-sized subgroups: blood heat syndrome group (BHS), blood stasis syndrome group (BSS), and non-blood heat nor blood stasis syndrome group (NHS) group. Participants will be grouped according to CM syndrome classification and receive oral CM herbal medication (according to the CM syndrome classification, and tailored to the participant’s disease progression). Medication will be administered twice every day during the intervention phase (eight weeks of intervention, and eight weeks of follow-up). Exposure measures include demographic variables, risk factors, and intervention factors.
Discussion: The primary outcome measures include improvement in both the psoriasis and severity index scores after eight weeks of intervention. Secondary outcome measures include body surface area affected, Physician Global Assessment scores, Dermatology Life Quality Index, pain-relat ed quality of life, pain on visual analog scale, CM syndromes, and recurrence. Other outcome measures include CM physical scale, personal history, medical expenses, and patient satisfaction. The number, nature, and severity of adverse events will be carefully recorded.
Trial registration: The trial has been registered at ClinicalTrials.gov (ID: NCT03942185).
Methods: The study is a prospective cohort clinical trial planned for October 2019 to September 2021 involving 20 clinics. The trial will enroll 1,500 participants in a psoriasis vulgaris group, and 500 healthy participants in a control group (no intervention). The psoriasis vulgaris group will be divided into three equal-sized subgroups: blood heat syndrome group (BHS), blood stasis syndrome group (BSS), and non-blood heat nor blood stasis syndrome group (NHS) group. Participants will be grouped according to CM syndrome classification and receive oral CM herbal medication (according to the CM syndrome classification, and tailored to the participant’s disease progression). Medication will be administered twice every day during the intervention phase (eight weeks of intervention, and eight weeks of follow-up). Exposure measures include demographic variables, risk factors, and intervention factors.
Discussion: The primary outcome measures include improvement in both the psoriasis and severity index scores after eight weeks of intervention. Secondary outcome measures include body surface area affected, Physician Global Assessment scores, Dermatology Life Quality Index, pain-relat ed quality of life, pain on visual analog scale, CM syndromes, and recurrence. Other outcome measures include CM physical scale, personal history, medical expenses, and patient satisfaction. The number, nature, and severity of adverse events will be carefully recorded.
Trial registration: The trial has been registered at ClinicalTrials.gov (ID: NCT03942185).
