A multicenter randomized controlled trial of Qingre Liangxue therapy for psoriasis blood-heat syndrome
- Conditions
- psoriasis
- Registration Number
- ITMCTR1900002639
- Lead Sponsor
- Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Western diagnostic criteria and diagnostic criteria for TCM syndromes that meet psoriasis;
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 the informed consent form.
1. Erythrodermic, arthritic, pustular psoriasis patients;
2. There are other active skin diseases that may affect the condition assessment;
3. Systematic treatment of research drugs, biological agents and immunosuppressive agents within 1 month;
4. Within 2 weeks, he received treatment with topical glucocorticoids, phototherapy, etc.;
5. During severe, uncontrollable local or systemic acute or chronic infections;
7. 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; main indicators of blood routine ( Any one of the white blood cell count, 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;
8. Patients with a history of malignant tumors and primary or secondary immunodeficiency and hypersensitivity patients;
9. Those who have participated in other drug clinical trials within 3 months;
10. Such surgery will be required during major surgery or study within 8 weeks;
11. For women of childbearing age who have fertility, no effective contraceptive measures have been taken from the screening period until the end of the last dose;
12. Pregnant or lactating women;
13. Those who have a history of alcohol abuse, drug abuse or drug abuse;
14. Those with a history of serious mental illness or family history;
15. The investigator considered it inappropriate to participate in the study.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PASI;
- Secondary Outcome Measures
Name Time Method PGA;VAS;BSA;DLQI;recurrence rate;PRQoL;TCM symptom score;