Clinical evaluation and multi-omics study of Chinese Medicine in combination with conventional therapy for the blood-stasis pattern of patients with moderate-to-severe psoriasis

Phase 1

Recruiting

• Conditions: Psoriasis

• Registration Number: ITMCTR2000003550
• 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. The age is 18-70 years old, both male and female;
2. The patients who meet the diagnostic criteria of psoriasis and the syndrome differentiation criteria of blood stasis syndrome of traditional Chinese medicine at the same time;
3. Patients with moderate to severe illness (BSA >= 3 or PASI >= 3);
4. Patients with informed consent.

Exclusion Criteria

1. Pregnant or lactating women, or those who plan pregnancy during the study period;
2. Patients with SAS score > 50 or SDS standard score > 53, or with other mental disorders;
3. Patients with severe primary diseases such as respiratory system and circulatory system that cannot be controlled by conventional medication; patients with severe infection, tuberculosis, hepatitis and other infectious history, lymphocyte proliferation, hematopoietic system abnormalities, tumor; patients with severe water, electrolyte and acid-base balance disorder; patients with primary or secondary immune deficiency and hypersensitivity. Or clinical test indicators are one of the following cases: alanine aminotransferase or glutamic oxaloacetic transaminase increase > 1.5 times the upper limit of normal value; creatinine is higher than 1.5 times of the upper limit of normal value; liver fibrosis (p3np) > 2 times of the upper limit of normal value; HIV serological test is positive; any of the main blood routine indicators is lower than the lower limit of normal value; or other abnormal laboratory tests are judged by researchers Patients who are not suitable for this trial;
4. Patients who are known to be allergic to the drugs used in this study and those with related drug ingredients;
5. Patients with head and face lesions;
6. Those who are participating in other drug clinical trials or have participated in other clinical trials within 12 weeks;
7. Those who used traditional Chinese medicine or Chinese herbal products or topical therapy (antibiotics, external corticosteroids, vitamin D3 analogues, calcineurin inhibitors, keratolytics, et al) within 2 weeks; those who had used oral systemic therapies (methotrexate, ciclosporin A, acitretin, fumarates, et al) or ultraviolet treatment within 4 weeks; those who had received biological agents within 5 half-life periods (17.5 days of Etanercept, 50 days of Infliximab, 70 days of Adalimumab, 105 days of Ustekinumab, 135 days of Secukinumab, et al);
8. The cumulative dose of MTX used in the past was more than 1.5g;
9. Patients considered unsuitable for inclusion by the researchers.

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
Pruritus Scores on the Visual Analogue Scale score;Main symptoms of psoriasis scale score;Patients' attitudes, expectation and experience;The improvement in PASI score from baseline after treatment;Dermatology Life Quality Index (DLQI);Physician's global assessment (PGA) score;The proportion of patients who achieve at least 90% improvement in PASI score from baseline;Relapse rate;Therapy compliance;The proportion of patients who achieve at least 50% improvement in PASI score from baseline;Skindex16;Rebound rate;