Efficacy and safety of fuzhiqing ointment in the treatment of perianal chronic eczema: a prospective, randomized, double-blind, controlled multicenter study

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•(1) The age ranged from 18 to 65 years old;
•(2) It was in accordance with the diagnostic criteria of perianal chronic eczema;
•(3) The subjects voluntarily signed a written informed consent form.

•(1) Eczema is found in the area outside the perianal skin;
•(2) Other active skin diseases (such as psoriasis, acne, syphilis, skin tuberculosis, lupus erythematosus, perioral dermatitis and acne vulgaris) that may affect the evaluation of the results.
•(3) There are serious diseases of heart, lung, liver, kidney, nerve, endocrine and other systems.
•(4) The laboratory examined the ALT >=60u/l, and the serum creatinine (CR) was more than 106 umol/l or bun was more than 7.14mmol/l;
•(5) The infection of bacteria, fungi or virus in the local or drug-use areas of skin lesions needs anti infection treatment;
•(6) The patients who had been treated with antihistamines within 2 weeks, who had received ultraviolet light therapy within 4 weeks, who had systemic application of aspirin, glucocorticoids or immunosuppressants within 4 weeks; those who used topical drugs in local skin lesions within 1 week, including skin moisturizers;
•(7) The drug with similar composition and chemical structure is known to have allergy history; the drug has a history of hypersensitivity to food and drug;
•(8) Participated in other clinical researchers of experimental drugs within 1 month;
•(9) Alcohol, drug abuse, known drug dependence;
•(10) Pregnant, prospective or lactating women and staff directly involved in the study;
•(11) Mental illness patients;
•(12) The researchers judged that it was not suitable for other cases to participate in clinical research.

发起方

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine