Exploring the effectiveness characteristics and preliminary observation of its safety of Huanglian Jiedu Pills in the treatment of excess heat fire-toxicity syndrome: a randomized, double-blind, placebo-controlled, multi-center phase II clinical trial

The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新: 2023年2月20日

试验速览

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•(1) Aged 18-65 years, male or female;
•(2) In line with the syndrome differentiation standard of excess heat fire-toxicity,use the diagnostic Rating Scale of the type of syndrome in the previous period to determine;
•(3) In line with one of the diagnostic criteria for oral ulcers, gingivitis or acute pharyngitis;
•(4) Within 2 days before enrollment no medication was used;
•(5) The patient has understood the test content and has signed the informed consent form,the process of obtaining informed consent is in compliance with GCP regulations.

•(1) Body temperature > 38.0 degree C or blood WBC > 11.0x10^9 /L or NEUT% > 85%;
•(2) With severe heart disease(Unstable angina ,Acute myocardial infarction within 6 months, severe arrhythmia, grade IV cardiac function, etc.) Severe respiratory disease (Acute bronchial asthma, chronic obstructive pulmonary disease, etc.) or other serious diseases.
•(3) Combined with severe liver and kidney damage (AST or ALT > 1.5 upper limits of normal,or TBil> upper limit of normal value,Or Cr> upper limit of the normal range);
•(4) This is not suitable which Body deficient cold of spleen and stomach for taking this product;
•(5) Women within 5 days (including 5 days) before menstruation;
•(6) Dysphagia or gastrointestinal system surgery affects drug absorption;
•(7) Positive pregnancy test, pregnant or lactating women, planned pregnancy;
•(8) Disabled patients prescribed by law (blindness, deafness, dumbness, mental retardation, mental disorders, etc.);
•(9) Can not follow the interventions specified in the program, plan to accept other disease treatment measures during the trial period;
•(10) Failure to follow the program rules for recording journal cards and regular followers;
•(11) The patients who have participated in other clinical trials within 1 months;
•(12) Researchers consider that the patients who are not suitable for enrollment.

发起方

The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine