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A randomized controlled trial of Guben Qushi Huayu Decoction Combined with Shenling Baizhu powder in the treatment of psoriasis with spleen deficiency and dampness obstruction syndrome

Phase 2
Conditions
psoriasis
Registration Number
ITMCTR2200005679
Lead Sponsor
Guangdong Provincial Hospital of Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

1.The age is 18-70 years old, both male or female; 2.The patients who meet the diagnostic criteria of stable plaque psoriasis; 3.The degree of skin lesions was moderate (3 = PASI < 10 or 3% = BSA < 10%); 4.The patients who meet the diagnostic criteria of dampness syndrome; 5.Patients with informed consent.

Exclusion Criteria

1.Drip type, reverse type, joint type, pustular type, erythrodermic psoriasis, or psoriasis vulgaris in progressive stage and regression stage. 2.Pregnant or lactating women, or those planning pregnancy within 1 year. 3.Patients with severe primary diseases such as respiratory system, circulatory system, digestive system, endocrine system and urinary system, which can not be controlled by conventional drugs; Patients with severe infection, hepatitis, pulmonary tuberculosis, lymphocyte proliferation, abnormal hematopoietic system and tumor; Patients with severe disorders of water, electrolyte and acid-base balance; Patients with primary or secondary immunodeficiency and hypersensitivity; Or patients whose clinical test indexes belong to one of the following situations: the increase of alanine aminotransferase or aspartate aminotransferase > 1.5 times the upper limit of normal value; The increase of creatinine > 1.5 times the upper limit of normal value; Hemoglobin increase > 20g / L, upper limit of normal value; Thrombocytopenia < 75.0 × 10e9/L Decrease in leukocyte count < 3.0 × 10e9/L The increase of blood potassium is more than 5.5mmol/l or the decrease is less than 3mmol / L, or other abnormal laboratory tests. The researchers judge that it is not suitable for patients to participate in this test. 4.Patients who are known to be allergic to the drugs used in this study and those containing related drug components. 5.Those who are participating in other drug clinical trials or have participated in other clinical trials within 1 month. 6.Patients considered unsuitable for inclusion by the researchers.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The proportion of patients who achieve at least 50% improvement in PASI score from baseline;
Secondary Outcome Measures
NameTimeMethod
Improvement of body surface area (BSA) of skin lesions;The improvement in PASI score from baseline after treatment;Improvement of patients' self-rated pruritus score (VAS);Dermatology Life Quality Index (DLQI) score decrease average;Therapy compliance;Physician's global assessment (PGA) score decrease average;The score of Main symptoms of psoriasis scale decreased by average;Pruritus Scores on the Visual Analogue Scale score decrease average;Skindex16 score decrease average;
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