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A clinical trial for the efficacy and safety of Pantao lithium-rich water in reducing uric acid in patients with primary hyperuricemia

A clinical trial for the efficacy and safety of Pantao lithium-rich water in reducing uric acid in patients with primary hyperuricemia

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030691
Enrollment
Unknown
Registered
2020-03-10
Start date
2019-10-14
Completion date
Unknown
Last updated
2021-08-30

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

Conditions

Primary Hyperuricemia

Interventions

1:0.13mg/L lithium ion content group
2:0.43mg/L lithium ion content group

Sponsors

The Affiliated Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
14 Years to 40 Years

Inclusion criteria

Inclusion criteria: (1) Aged 12 to 40 years, male, meeting the diagnostic criteria for hyperuricemia; (2) Serum uric acid >= 420umol/L(7mg/dL); (3) Obtain the consent of the subject, or family members, or guardian, or legal representative and sign the informed consent;

Exclusion criteria

Exclusion criteria: (1) Allergies or contraindications to ingredients, or allergies or hypersensitive constitutions; (2) Those who had acute gouty arthritis in the first two weeks at random; (3) Use of hypouric acid drugs within the first two weeks at random; (4) Glucocorticoids, anti-tuberculosis drugs (e.g. ethambutol, pyrazinamide), anticoagulants (e.g. warfarin or other coumarin anticoagulants, bivalirudin), immunosuppressants (e.g. cyclosporine, tacrolimus), aspirin or other salicylic acid substances, azathioprine, 6-mercaptopurine, cyclophosphamide, sulfur) were used or planned to be used within the first two weeks of randomization. Aminoxazole, trimethoprim, theophylline, nicotinic acid, estrogen and other drugs affecting uric acid metabolism; (5) Patients with active gastrointestinal ulcer, thyroid dysfunction, malignant tumors, active tuberculosis and urinary calculi; (6) Arthritis caused by rheumatoid arthritis, rheumatoid arthritis and other rheumatic immune diseases, or osteoarthritis requiring analgesic treatment; (7) Heart failure with limited activity (previously diagnosed, or clinical manifestations of heart failure, confirmed after consultation with cardiology department), unstable angina pectoris, past 12 months with a history of myocardial infarction or other serious heart disease patients; (8) Patients with secondary hyperuricemia caused by hematological diseases, malignant tumors, kidney diseases or tumor radiotherapy and chemotherapy; (9) For severe renal insufficiency (eGFR 1.5 times ULN or TBIL > 1.5 times ULN]; (11) Patients with severe hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg) who were not effectively controlled after treatment; (12) Patients who are receiving hypoglycemic drugs or not receiving hypoglycemic drugs but with HbA1c > 8%; (13) Leukocyte count < 3.5 x 10^9/L, platelet < 100 x 10^9/L, or hemoglobin < 90 g/L; (14) Those with brain diseases, abnormal judgment and mental disorders who can not cooperate; (15) A history of alcohol abuse or illegal drug use; (16) Pregnant women, lactating women or pregnant women (including male subjects); (17) Other researchers considered it inappropriate to participate in the experiment.

Design outcomes

Primary

MeasureTime frame
Serum uric acid;

Secondary

MeasureTime frame
Serum homocysteine;Blood routine;Urine routine;Blood biochemistry;Blood pressure;Ultrasound of urinary system;Six sex hormones;

Countries

China

Contacts

Public ContactLi Changgui

The Affiliated Hospital of Qingdao University

changguili@vip.163.com+86 13969620056

Outcome results

None listed

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