Phase
Condition
Collagen Vascular Diseases
Bone Diseases
Musculoskeletal Diseases
Treatment
uric-acid-lowering drug
Sodium Bicarbonate Oral Capsule
Potassium Citrate Tablets
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Meet the diagnostic criteria of the American College of Rheumatology (ACR) and theEuropean League against Rheumatism (EULAR) for gout in 2015
Age 18-70 years old, gender is not limited
The interval between the most recent acute onset of gout is at least > 2 weeks
Routine treatment with stable dose of uric-lowering drugs for > 4 weeks
For women who are likely to become pregnant, pregnancy tests must be negative, theymust not be lactating, they must be using an investigator-approved method ofcontraception, and they must agree to maintain this method of contraceptionthroughout the study
Study participants were informed, voluntarily signed informed consent, and agreed toparticipate in all visits, examinations, and treatments as required by the trialprotocol
Informed consent to the purpose and content of the research.
Exclusion
Exclusion Criteria:
Acute gout flare
Secondary gout caused by kidney disease, blood disease, or taking certain drugs,tumor radiotherapy and chemotherapy
Severe and unstable cardiovascular and cerebrovascular diseases (such as unstableangina pectoris, coronary angiogenesis, cerebral angiogenesis, transient ischemicattack, congestive heart failure, etc.), acute and difficult to control diseases,chronic diffuse connective tissue disease, xanthine urethral deposition, Lesch-Nyhansyndrome, untreated thyroid disease or kidney stones, treatment Patients with severehypertension (blood pressure > 160/100mmHg) or diabetes (fasting blood glucose > 11.1mmol/L) and organ transplantation that were not effectively controlled later
People who are allergic, have a history of allergy to test-related drugs (febuxositatablets, allopurinol tablets, benzbromarone, etoracoxib, colchicine, potassiumcitrate, etc.) or are allergic to test-related drug components
Active peptic ulcer or ulcer with bleeding and perforation, severe chronic diarrheaor recurrent skin disease in the past year
Blood white blood cell count < 3.0x109/L, hemoglobin < 90g/L, platelet count < 100x109/L, or other blood system diseases (such as severe anemia, idiopathicthrombocytopenic purpura, spleen enlargement, coagulation dysfunction, etc.)
Active stage of liver disease or abnormal liver function (ALT or AST≥2 times theupper limit of normal)
Patients with abnormal renal function (eGFR≤60ml/min/1.73m^2)
Patients with elevated blood potassium (5.5mmol/L) may have diseases or factors thatmay lead to hyperkalemia, such as type IV renal tubular acidosis and widespreadtissue injury
Urine PH value > 6.5 during screening
Combined use of the following drugs: Contains salicylate drugs such as aspirin (> 300mg/d), thiazide diuretics, potassium diuretics such as amphenopterine, Amiloride,ACEI, azathioprine, 6-mercaptopurine, theophylline, losartan, cyclosporin A,cyclophospfamide, pyrazinamide, glucocorticoid (except in acute episodes),Niergoline tablets, long-term use of insulin, Digitalis
Women who are pregnant, planning to become pregnant or breastfeeding mental illness,no self-knowledge, unable to accurately express or can not take drugs on time
A history of alcohol abuse or dependence on known drugs within the last two years
Those who have participated or are participating in other clinical trials withinthree months
The study participant is a family member or relative of the staff of the researchCenter
Other lesions or conditions that, in the investigator's judgment, reduce orcomplicate enrollment.
Study Design
Connect with a study center
Huashan hospital, Fudan university
Shanghai,
ChinaActive - Recruiting
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