Oral Chinese Herbal Medicine for Psoriasis Vulgaris With Blood Heat Syndrome

• Status: Not yet recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

We designed this study as a multicenter, randomized, double blinded and placebo-controlled clinical trial. The aim of the study is to evaluate the clinical efficacy, safety and control of recurrence rate of psoriasis with blood stasis syndrome.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Yueyang Integrated Medicine Hospital
• Collaborators: Affiliated Hospital of Gansu University of Chinese Medicine; Beijing Hospital of Traditional Chinese Medicine; First Affiliated Hospital of Anhui University of Traditional Chinese Medicine; Guangxi Zhuang Autonomous Region Dermatology Hospital

Criteria

Inclusion Criteria:

1. Comply with the diagnostic criteria of Western medicine for psoriasis and the diagnostic criteria for TCM syndromes;

2. Skin lesions involve ≤10% BSA (the lesions are mainly located in the trunk and/or limbs, palm/sole, face/scalp, vulva area is not included);

3. Age between 18 and 65 years old;

4. Those who voluntarily participate in the study and sign informed consent.

Exclusion Criteria:

1. Patients with erythrodermic, arthritic, pustular or punctate psoriasis;

2. Other active skin diseases may affect the condition assessment;

3. Received research drugs, biological agents and immunosuppressive agents within 1 month;

4. 2 weeks of treatment with topical glucocorticoids, phototherapy, etc.;

5. During severe, uncontrollable local or systemic acute or chronic infections;

6. Patients with severe systemic diseases; or clinical test indicators in one of the following conditions: alanine aminotransferase or aspartate aminotransferase increased by >1.5 times the upper limit of normal; creatinine increased by 1.5 times the upper limit of normal; blood routine indicators (white blood cell count) Any one of the red blood cell count, hemoglobin amount, and platelet count) is below the lower limit of normal; or other laboratory abnormalities are judged by the investigator to be unsuitable for participation in the trial;

7. A history of malignant tumors and patients with primary or secondary immunodeficiency and hypersensitivity;

8. Such surgery will be required during major surgery or study during 8 weeks;

9. Pregnant or lactating women;

10. A person with a history of alcohol abuse, drug abuse or drug abuse;

11. Have a history of serious mental illness or family history;

12. Other reasons researchers believe that it is inappropriate to participate in this research.