Removing-Dampness Method for Treatment of Moderate Plaque Psoriasis: an Exploratory Clinical Trial

Phase 1

Recruiting

• Conditions: psoriasis

• Registration Number: ITMCTR2000003389
• Lead Sponsor: Guangdong Provincial Hospital of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Aged 18 to 70 years, not restrictions on male or female;
2. Patients who meet the diagnostic criteria of stable plaque psoriasis;
3. 3 <= PASI < 10;
4. Fill in the syndrome diagnostic criteria of dampness syndrome and non-dampness syndrome;
5. Informed consent.

Exclusion Criteria

1. Pregnancy, breastfeeding women, or a planned pregnancy within one year;
2. Vulgaris psoriasis patients with severe primary diseases involving respiratory system, circulatory system, digestive system, endocrine system and urinary system, etc., which can not be controlled by comment medicine.Vulgaris psoriasis patients with severe infection, hepatitis, tuberculosis, lymphocytic hyperplasia, abnormal hematopoietic system and tumor.Vulgaris psoriasis patients with severe water, electrolyte and acid-base balance disorders.Vulgaris psoriasis patients with primary or secondary immunodeficiency and hypersensitivity.Or the clinical test index is one of the following: the ALT or the AST is higher than 1.5 times the normal value limit; the creatinine (Cr) is higher than 1.5 times the normal value limit; Hemoglobin increase > 20g/L upper limit of normal value; Decreased platelet count < 75.0 * 10^9/L; Leukocyte count decreased < 3.0 * 10^9/L; Serum potassium increased > by 5.5mmol/L or decreased by < 3mmol/L; or patients with other abnormal laboratory tests that the researchers judged unfit to participate in the trial;
3. They are known to be allergic to drugs used in the study and those who are allergic to the drugs involved.
4. Participants in other clinical trials or other clinical trials in 1 month;
5. Patients who the researchers consider are not suitable for inclusion.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of patients who achieve at least 75% improvement in PASI score from baseline;

Secondary Outcome Measures

Name	Time	Method
Subject satisfaction;Average decrease of Skindex16 score;Improvement of Pruritus Scores on the Visual Analogue Scale;Average decrease of VAS score;The average score of the Main Symptom scale for Psoriasis Vulgaris decreased;Medication compliance;Average decrease of Dermatology Life Quality Index (DLQI) score;Improvement of Body Surface Area;Average decrease of Physician's global assessment (PGA) score;The improvement in PASI score from baseline after treatment;