ITMCTR1900025326
Recruiting
Phase 2
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 sitesTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(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.
Exclusion Criteria
- •(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;
Outcomes
Primary Outcomes
Not specified
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