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Effects of Marine fish polypeptide on serum Uric acid in patients with hyperuricemia

Effects of Marine fish polypeptide on serum Uric acid in patients with hyperuricemia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112736
Enrollment
Unknown
Registered
2025-11-19
Start date
2024-09-11
Completion date
Unknown
Last updated
2025-11-24

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

Conditions

Hyperuricemia

Interventions

AB group:Patients who initially received conventional interventions combined with marine fish protein peptides were switched to only conventional interventions after a crossover, with a 2-week washout
BA group:Those who initially received only conventional interventions were switched to conventional interventions combined with marine fish protein peptides after a crossover, with a 2-week washout pe

Sponsors

The Third Affiliated Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Voluntarily sign informed consent. 2.18~65years old. 3.Either male or female. 4.According to the Guidelines for the Diagnosis and Treatment of Hyperuricemia and Gout in China (2019), patients diagnosed with hyperuricemia should have a serum uric acid level >of 480 µmol/L twice within 3 months. 5.No urico-lowering drugs have been used. 6.Or have used uric acid lowering drugs in the past, but stopped taking them for more than 4 weeks. 7.No history of food allergy or intolerance, no blood phobia. 8.Be able to tolerate at least 10 hours of fasting. 9.Be able to understand and follow the test procedure and participate in the test voluntarily.

Exclusion criteria

Exclusion criteria: 1.All the drugs used in this test or the ingredients in them are allergic or contraindicated, or have existing allergic or hypersensitive constitution 2.Had a history of acute gouty arthritis before randomization 3.Urico-lowering drugs were used within 4 weeks prior to randomization 4.Use or planned use of glucocorticoids, antituberculous drugs (such as ethambutol, pyrazinamide), anticoagulants (such as warfarin or other coumarin-based anticoagulants, bivalirudin), immunosuppressants (such as cyclosporine, tacrolimus), aspirin or other salicylic acid-like substances, azathioprine, 6-mercaptopurine, cyclophosphamide, sulfamethoxazole, trimethoprim, theophylline, niacin, estrogen and other drugs that affect uric acid metabolism within 4 weeks before randomization; 5.Patients with active stage of digestive ulcer, abnormal thyroid function, malignant tumor, active tuberculosis, urinary calculi 6.Has a confirmed diagnosis of rheumatoid arthritis, rheumatoid arthritis, arthritis due to other rheumatoid immune diseases, or osteoarthritis requiring treatment with analgesics 7.Patients with limited mobility with heart failure (previously diagnosed, or with clinical manifestations of heart failure, confirmed after a cardiology consultation), unstable angina pectoris, a history of myocardial infarction within the previous 12 months, or other serious heart disease 8.Patients with secondary hyperuricemia caused by hemopathy, malignant tumor, kidney disease or tumor radiotherapy and chemotherapy 9.Patients with severe renal insufficiency (eGFR 160mmHg or diastolic blood pressure > 100mmHg) that was not effectively controlled after treatment. 12.Patients who are receiving hypoglycemic drugs or not receiving hypoglycemic drugs but have HbA1c >8%.. 13.White blood cell count <3.5 x 10^9 /L,or platelet <100 x 10^9 /L ,or hemoglobin<90g/L. 14.Brain disease, abnormal judgment ability, mental disorders can not cooperate. 15.Alcohol abuse or history of illicit drug use. 16.Pregnant women, breastfeeding women, or pregnant women (including male subjects). 17.Participants who had participated in other clinical trials within three months prior to screening. 18.Other conditions deemed inappropriate by the investigator to participate in the trial.

Design outcomes

Primary

MeasureTime frame
Uric acid;

Secondary

MeasureTime frame
Blood Glucose;Serum Insulin;Renal Function;Liver Function ;Homocysteine;Cystatin C;

Countries

China

Contacts

Public ContactLi Chengzhong

The Third Affiliated Hospital of Southern Medical University

xichongli@163.com+86 20 6278 4240

Outcome results

None listed

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