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Randomized, double-blind, double-simulated, parallel-controlled clinical trials of the efficacy and safety of Medicinal Charcoal Tablets in the treatment of primary gout with hyperuricemia

Randomized, double-blind, double-simulated, parallel-controlled clinical trials of the efficacy and safety of Medicinal Charcoal Tablets in the treatment of primary gout with hyperuricemia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034138
Enrollment
Unknown
Registered
2020-06-25
Start date
2020-08-01
Completion date
Unknown
Last updated
2020-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gout

Interventions

Experimental group:Febuxostat 20mg, 2 tablets, qd
medicinal carbon tablets analog, 8 tablets, tid
Experimental group:Febuxostat 20mg, 1 tablet, febuxostat analog tablet, 1 tablet, qd
medicinal carbon tablets, 5 tablets, medicinal carbon tablets analog, 3 tablets, tid
medicinal carbon tablets, 8 tablets, tid
control group:Febuxostat 20mg, 1 tablet, febuxostat analog tablet, 1 tablet, qd

Sponsors

Affiliated Hospital of Qiingdao University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Men aged 18-70 years; 2. After 2 weeks of washout, the serum uric acid of patients who met the diagnostic criteria of primary gout was >= 7.0 mg / dl (416 µ mol / L); 3. EGFR >= 30ml / min / 1.73m2 and serum creatinine < 177umol / L (normal renal function or compensatory period); 4. The patients who did not attack acute gouty arthritis in the first 2 weeks and the elution period were selected; 5. Patients who voluntarily participate in and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. The patients who are known to be allergic to the drugs used in the test or the ingredients in the test, or who are allergic to the current symptoms or have high sensitive constitution; 2. Patients with active liver disease or cirrhosis, or abnormal liver function, whose serum alanine aminotransferase (ALT) and glutamic oxaloacetylase (AST) are 1.5 times higher than the upper limit of normal range; 3. Patients with biliary diseases: biliary malformation, cholelithiasis, acute and chronic cholecystitis, cholangitis; 4. Patients with digestive diseases: constipation, obstruction, active stage of peptic ulcer; 5. Patients with abnormal thyroid function; 6. EGFR = 177umol / L; 7. Patients with serious heart disease, such as: decompensated heart failure (NYHA stage III and IV); unstable angina; previous history of myocardial infarction within 12 months; 8. Patients with xanthinuria; 9. Patients with rheumatoid arthritis and other joint diseases that need treatment; 10. Patients who are currently being treated with azathioprine, 6-mercaptopurine, cyclosporine, cyclophosphamide, bizinamide, sulfamethoxazole, trimethoprim, theophylline, thiazide diuretics, aspirin (more than 325mg / day) or other salicylic acid drugs, losartan, colchicine for intravenous use; 11. Patients with secondary hyperuricemia caused by hematopathy, kidney disease or tumor radiotherapy and chemotherapy; 12. Patients with brain diseases, patients with abnormal judgment ability, patients with mental disorders and uncooperative patients; 13. Those who drink or use drugs; 14. Patients who have participated in other clinical trials within three months before the screening of this trial; 15. Patients with malignant tumor and active tuberculosis; 16. Patients with other diseases, and the researchers think that the evaluation of curative effect or compliance is poor; 17. Patients taking glucocorticoids; 18. White blood cell count < 4.0 * 10 ^ 9 / L, platelet < 100 * 10 ^ 9 / L, hemoglobin < 90g / L; 19. Subjects who, for any other reason, were not considered suitable for the study.

Design outcomes

Primary

MeasureTime frame
Serum uric acid;

Secondary

MeasureTime frame
Blood routine;Blood biochemistry;Erythrocyte sedimentation rate;Urine routine;CRP;CA72-4;Ultrasound of urinary system;Joint ultrasound;Joint dual-source CT;eGFR;The frequency of acute gout;

Countries

China

Contacts

Public ContactLi Changgui

Qingdao University

changguili@vip.163.com+86 13969620056

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026