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A randomized, double-blind, placebo-controlled, multicenter clinical trial of Yinxieping tablets in the treatment of mild to moderate psoriasis vulgaris

Phase 1
Conditions
Psoriasis vulgaris
Registration Number
ITMCTR2100005102
Lead Sponsor
Shaanxi Traditional Chinese Medicine Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

1. Meet the diagnostic criteria of Western medicine for guttate or plaque psoriasis and the diagnostic criteria for TCM syndromes of psoriasis;
2. Skin lesions involving <=10% BSA;
3. PASI score<=12;
4. Aged 18-65 years, gender is not limited;
5. Those who agree to participate in this study and sign the informed consent form.

Exclusion Criteria

1. Those with other active skin diseases that may affect the assessment of the condition;
2. Have systematically received treatment with investigational drugs, biological agents and immunosuppressive agents within 1 month;
3. Received topical corticosteroids, phototherapy and other treatments within 2 weeks;
4. In a state of severe and uncontrollable local or systemic acute or chronic infection;
5. Patients with severe systemic diseases; or patients whose clinical test indicators belong to one of the following conditions: increased alanine aminotransferase or aspartate aminotransferase > 1.5 times the upper limit of normal; increased creatinine > the upper limit of normal; any one of the main indicators of blood routine (white blood cell count, hemoglobin concentration, platelet count) < the lower limit of normal value or > > the upper limit of normal value; or other abnormal laboratory examinations in patients who are not suitable for participating in this trial;
6. Patients with a history of malignant tumors and patients with primary or secondary immunodeficiency and hypersensitivity;
7. Have undergone major surgery within 8 weeks or will require such surgery during the study;
8. Pregnant or lactating patients;
9. Those with a history of alcohol, drug or drug abuse;
10. Those with a history of serious mental illness or family history;
11. Participate in other clinical trials;
12. For other reasons, the researcher believes that it is not suitable to participate in this researcher.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
psoriasis area and severity index;
Secondary Outcome Measures
NameTimeMethod
onset time;body surface area;dermatology life quality index;recurrence rate;visual analogue scale;
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