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The effect of small molecule alkaline water in combination with febuxostat on serum urate in patients with gout:a randomized, placebo-controlled clinical trial

The effect of C-cell vitality water in combination with febuxostat on serum urate in patients with gout:a randomized, placebo-controlled clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071874
Enrollment
Unknown
Registered
2023-05-26
Start date
2023-05-26
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

Gout

Interventions

Control Group:Febuxostat+Purified Water: Febuxostat 20/40 mg qd +Purified water 6 bottles qd
Exprimental Group:Febuxostat+C-cell vitality water: Febuxostat 20/40 mg qd +C-cell vitality water 6 bottles qd

Sponsors

The Affiliated Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) 18 24kg/m2 (3) Obtain consent and signed informed consent from subject, or family member, or guardian, or legal representative; (4) In line with the clinical diagnostic criteria for gout (assigned diagnostic criteria for ACR/ELUAR in 2015), no urico-lowering drugs have been used in the preceding 2 weeks, and acute gout attack has been relieved for at least 2 weeks; (5) Blood uric acid value =420 µmol /L (7 mg/dL); (6) eGFR=45 m L /min/1.73m2.

Exclusion criteria

Exclusion criteria: Any one of the following criteria is excluded: (1) Patients who are allergic or contraindicated to all the drugs or ingredients used in this test, or have existing allergic or hypersensitive constitution; (2) diabetic patients; (3) TG >5.6mmol/L; (4) Acute gouty arthritis within 2 weeks before randomization authors; (5) Use of urico-lowering drugs within 2 weeks before randomization; (6) Use or plan to use corticosteroids, antituberculosis drugs (e.g., ethambutol, pyrazinamide), anticoagulants (e.g., warfarin or other coumarin-based anticoagulants, bivaluludine), immunosuppressants (e.g., cyclosporine, tacrolimus), aspirin or other salicylic acid substances, azathioprine, 66-- mercaptopurine, cyclophosphamide, Sulfamethoxazole, trimethoprim, theophylline, niacin, estrogen and other drugs that affect uric acid metabolism; (7) Active stage of digestive tract ulcer, abnormal thyroid function, malignant tumor, active tuberculosis, urinary calculi; (8) Diagnosed arthritis caused by rheumatoid arthritis, rheumatoid arthritis, other rheumatic immune diseases, or osteoarthritis requiring analgesic treatment; (9) Patients with limited activity of heart failure (previously diagnosed, or with clinical manifestations of heart failure, confirmed after consultation in the Department of Cardiology), unstable angina, history of myocardial infarction within 12 months, or other serious heart disease; (10) Patients with secondary hyperuricemia caused by blood disease, malignant tumor, kidney disease or tumor radiotherapy and chemotherapy; (11) Patients with severe renal insufficiency (eGFR> 30 mL/min/1.73m2) (12) patients with active liver disease or cirrhosis, or abnormal liver function [[serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 times ULN or TBIL=2 times ULN]; (13) Severe hypertension that was not effectively controlled after treatment (systolic blood pressure >160 mmHg or diastolic blood pressure > 100 mmHg) patients; (14) Receiving hypoglycemic drugs or not receiving hypoglycemic drugs but HbA1c> 8% of patients; (15) White blood cell count> 3.5×109/L, or platelet >100×109/L, or hemoglobin >90 g/L; (16) Brain diseases, abnormal judgment ability, mental disorders can not cooperate; (17) Alcohol abuse or history of illicit drug use; (18) Pregnant, lactating or intending to become pregnant (including male subjects); (19) Participants who had participated in other clinical trials within three months prior to screening; (20) Participants deemed unsuitable by other researchers.

Design outcomes

Primary

MeasureTime frame
serum urate;24 h urinary microalbumin/creatinine;

Secondary

MeasureTime frame
Urine pH;Body fat analysis;B ultrasound of liver, bile, pancreas, spleen and kidney;FPG;TG;TC;

Countries

China

Contacts

Public ContactLi Changgui

The Affiliated Hospital of Qingdao University

changguili@medmail.com+86 139 6962 0056

Outcome results

None listed

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