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Clinical trial of Aixite medicinal charcoal tablets in preventing acute attack during the treatment of primary gout and reducing uric acid

Clinical trial of Aixite medicinal charcoal tablets in preventing acute attack during the treatment of primary gout and reducing uric acid

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066023
Enrollment
Unknown
Registered
2022-11-22
Start date
2022-11-21
Completion date
Unknown
Last updated
2023-05-15

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 40mg+medicinal carbon tablets
control group A:Febresta 40mg qd+colchicine 0.5mg qd
control group B:Febuxostat 40mg Qd

Sponsors

Affiliated Hospital of Qiingdao University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) 18~70 years old, male; 2) It meets the diagnostic criteria for primary gout, and the serum uric acid is = 7.0 mg/dL (416 µ mol/L) 3) EGFR = 30ml/min/1.73m2 and serum creatinine<177umol/L (normal renal function or compensatory stage); 4) Acute gouty arthritis occurred in recent 3 months; 5) Voluntary participation and signing of informed consent

Exclusion criteria

Exclusion criteria: 1) Patients with severe gout stone and gout chronic arthritis have no significant remission. 2) Patients with active liver disease or liver cirrhosis, or abnormal liver function, serum alanine aminotransferase (ALT) The oxaloacetic transaminase (AST) exceeds twice the upper limit of the normal range; 3) Biliary diseases: patients with biliary malformation, cholelithiasis, acute and chronic cholecystitis, and cholangitis; 4) Digestive tract diseases: patients with constipation, obstruction and active digestive tract ulcer; 5) EGFR < 30ml/min/1.73m2 or blood creatinine (Cr) = 177umol/L; 6) Patients with severe heart disease, such as decompensated heart failure (NYHA III and IV); Unstable core angina; History of myocardial infarction in the past 12 months; 7) Patients with xanthinuria; 8) Rheumatoid arthritis requiring treatment and joint diseases caused by other reasons; 9) Azathioprine, 6-mercaptopurine, cyclosporine, cyclophosphamide, bisazinamide, sulfamethoxazole are being used Azole, trimethoprim, theophylline, thiazide diuretics, aspirin (more than 325 mg/day) or others Those who are treated with drugs of salicylic acid, losartan and intravenous colchicine; 10) Patients with secondary hyperuricemia caused by blood disease, kidney disease or tumor radiotherapy and chemotherapy; 11) Alcoholics or drug addicts; 12) Those who have participated in other clinical trials within three months before screening; 13) Malignant tumors and active tuberculosis; 14) Complicated with other diseases, and the researcher thinks that the efficacy evaluation or compliance is poor; 15) Those taking glucocorticoids; 16) White blood cell count < 4.0 × one hundred and nine /50. Or platelet<100 × one hundred and nine /50. Or hemoglobin<90g/L;

Design outcomes

Primary

MeasureTime frame
Gout flares;SU;

Secondary

MeasureTime frame
Blood biochemistry;Urine routine;Ultrasound of urinary system;Joint ultrasound;Joint dual-source CT;

Countries

China

Contacts

Public ContactLi changgui

Affiliated Hospital of Qiingdao University

664573754@qq.com16678637856

Outcome results

None listed

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