Chinese Medicine in combination with western medicine for the prevention of relapse in patients with severe psoriasis

Phase 1

• Conditions: Psoriasis

• Registration Number: ITMCTR2100005464
• 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: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.The age is 18-70 years old, both male and female;
2.The patients with PASI=10 or BSA=10 met the diagnostic criteria of severe psoriasis;
3.Patients who meet the indications of biological agents Ixekizumab and have no history of inflammatory bowel disease (IBD);
4.Patients who sign informed consent.

Exclusion Criteria

1.Pregnant or lactating women, or those who plan pregnancy during the study period.
2.Patients with Self-Rating Anxiety Scale (SAS) score > 50 or Self-rating depression scale (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 > 3 times of the upper limit of normal value; creatinine is higher than 1.5 times of the upper limit of normal value; creatinine > 1.5 times of the upper limit of normal value; serological test of human immunodeficiency virus (HIV) is positive; Any main indicators of blood test is below the lower limit of normal; or patients are assessed as unsuitable for this trial by researchers through other abnormal laboratory tests.
4.Patients who are known to be allergic to the medication and its related ingredients used in this study and those with related medication ingredients.
5.Those who are participating in other medication clinical trials or have participated in other clinical trials within 4 weeks.
6.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).
7.Patients are assessed as unsuitable for inclusion by the researchers.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Relapse rate;

Secondary Outcome Measures

Name	Time	Method
Physician's global assessment (PGA) score;Patients' attitudes, expectation and experience;The proportion of patients who achieve at least 75% improvement in PASI score from baseline;The proportion of patients who achieve at least 90% improvement in PASI score from baseline;Skindex16;Pruritus Scores on the Visual Analogue Scale;The improvement in PASI score from baseline after treatment;Dermatology Life Quality Index (DLQI);Time to relapse;Body Surface Area;