A multicenter randomized double-blind parallel controlled trial of chuangui clearing damp mixture in the treatment of primary hyperuricemia
- Conditions
- Primary hyperuricemia
- Registration Number
- ITMCTR2100004310
- Lead Sponsor
- Affiliated Hospital of Qingdao University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
(1) Regular residents of Huangshan Village, Laoshan District, Qingdao City and Beizhai Health Center, Qingdao City, Shandong Province, and outpatients or inpatients of the endocrinology department of the Affiliated Hospital of Qingdao University and Rizhao People's Hospital, aged between 18 and 75 years old, diagnosed with hyperuricemia and meeting the standard of TCM syndrome differentiation of humidity and turbidities;
(2) Patients with non-acute gout;
(3) Patients who signed the informed consent to take the medication as required by the study protocol and were evaluated.
(1) secondary gout has been clearly diagnosed;
(2) You are taking drugs for blood uric acid metabolism, such as dihydroclorazide, furosemide, diuric acid, pyrazinamide, low-dose aspirin, etc., as well as drugs containing the above-mentioned ingredients, such as compound antihypertensive tablets;Or had taken glucocorticoids within 1 month before enrollment;Or use of nonsteroidal anti-inflammatory drugs or other pain medications within 48 hours prior to baseline evaluation;
(3) patients with xanthuria;
(4) Joint diseases caused by rheumatoid arthritis requiring treatment or other reasons;
(5) with severe cardiovascular diseases (such as: decompensated heart failure (NYHA ? and IV);Unstable angina pectoris;A history of myocardial infarction within the previous 12 months), heart failure, tumor activity, immunodeficiency, or severe infection
(6) Patients with active liver disease or cirrhosis, or abnormal liver function, with serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) exceeding 1.5 times the upper limit of the normal range;
(7) The serum creatinine (Cr) exceeds the upper limit of the reference range;
(8) patients with late deformity, disability or loss of working ability;
(9) Patients with active gastrointestinal ulcer or taking anti-ulcer drugs;
(10) People with brain diseases, abnormal judgment, mental or legal disabilities
(11) Suspected or confirmed history of alcohol or drug abuse, or other diseases that, according to the investigator's judgment, reduce the possibility of inclusion or complicate inclusion, such as frequent changes in the work environment, which may easily cause loss of follow-up;
(12) Women who are pregnant, lactating or have a recent birth plan;
(13) People who are known to be allergic to the ingredients of this drug;
(14) Candidates who have participated in or are participating in the clinical trial within the last 3 months, or whom the investigator considers unsuitable for the clinical trial for other reasons.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in serum uric acid level before and after treatment;Percent of subjects with serum uric acid (SUA) level less than 6.0mg/dL (357µmol/L) at the last visit;
- Secondary Outcome Measures
Name Time Method The incidence of remedial treatment;Evaluation criteria for patients' overall treatment effect after the end of treatment;The incidence of acute gout episodes to the end of follow-up;