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Randomized, parallel controlled trial for efficacy and safety of Qinglingweishi for patients with primary gout and hyperuricemia

Randomized, parallel controlled trial for efficacy and safety of Qinglingweishi for patients with primary gout and hyperuricemia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800018518
Enrollment
Unknown
Registered
2018-09-21
Start date
2018-09-10
Completion date
Unknown
Last updated
2018-09-24

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

Conditions

gout

Interventions

control group:Benzbromarone Tablet 25mg qd +Sodium Bicarbonate Tablets 1g tid (Initial treatment)
Benzbromarone Tablet 50mg qd +Sodium Bicarbonate Tablets 1g tid (Adjustment based on uric acid level)
experimental group:Benzbromarone Tablet 25mg qd +qinglingweishi 3.5g bid (Initial treatment)
Benzbromarone Tablet 50mg qd + qinglingweishi 3.5g bid (Adjustment based on uric acid level)

Sponsors

Affiliated Hospital of Qiingdao University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
17 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) 18~70 years old male; 2) conform to the diagnostic criteria of primary gout, 8.0 mg/dL (476 micromol/L) < serum uric acid < 9.7 mg/dL (576 umol/L); 3) morning urine pH was less than 6; 4) no acute gouty arthritis authors were found in the first 2 weeks and 2 weeks of elution; 5) voluntarily attend and sign informed consent.

Exclusion criteria

Exclusion criteria: 1) allergic to all drugs, foods or their ingredients, or allergic to symptoms or allergic constitution; 2) In patients with active liver disease or cirrhosis, or with abnormal liver function, serum alanine aminotransferase (ALT) and glutamic oxaloacetic aminotransferase (AST) exceeded the upper limit of normal range by 1.5 times; 3) patients with active gastrointestinal ulcer; 4) thyroid dysfunction; 5) glomerular filtration rate was <60ml/min; 6) Severe heart disease patients, such as: decompensated heart failure (NYHA stage III and IV); unstable angina pectoris; past 12 months with a history of myocardial infarction; 7) kidney stones, renal cysts, sponge kidney or other obstructive nephropathy; 8) patients with xanthine inuresis; 9) rheumatoid arthritis and other causes of joint disease requiring treatment; 10) azathioprine, 6-mercaptopurine, cyclosporine, cyclophosphamide, bizinamide, sulfamethoxazole, trimethoprim, theophylline, thiazide diuretics, aspirin (more than 325mg/day) or other salicylic acid substances, losartan, intravenous colchicine treatment; 11) patients with secondary hyperuricemia caused by hematological diseases, renal diseases or tumor radiotherapy and chemotherapy; 12) brain disease, abnormal judgement; mental illness can not cooperate; 13) alcoholics or drug addicts; 14) Pregnancy, breastfeeding or intentional pregnancy, women of childbearing age who do not use effective contraceptive measures (referring to intrauterine devices, oral contraceptives and obstructive measures); 15) during the first three months of the study, other clinical trials were included; 16) malignant tumor and active tuberculosis; 17) concurrent with other diseases, and the researchers believe that the effect of evaluation or compliance is poor; 18) those taking corticosteroids; 19) white blood cell count < 4 x 10^9/L, or platelets < 100 x 109/L, or hemoglobin 90g/L; 20) for any other reason, the researchers consider it inappropriate to participate in the trial.

Design outcomes

Primary

MeasureTime frame
Blood uric acid value;PH of urine;

Secondary

MeasureTime frame
fraction excretion of uric acid;Triglyceride;AST ALT;blood pressure;cholesterol;blood sugar;Urinary system ultrasound;eGFR, Estimated Glomerular Filtration Rate;

Countries

China

Contacts

Public ContactLi Changgui

Affiliated Hospital of Qiingdao University

changguili@vip.163.com+86 13969620056

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 17, 2026