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To evaluate whether alkalization has the effect of lowering uric acid and reducing gout flare and determine whether alkalization has a role in the prevention and treatment of urinary calculi in gout, the research participants were divided into the control group, the potassium citrate group and the sodium bicarbonate group. 2 alkalization groups took potassium citrate three times a day 2.16g each time, or sodium bicarbonate three times a day, 1.0g each time, on the basis of the standard uric acid-lowering treatment plan. The control group was treated with the standard uric acid-lowering treatment regimen alone. Uric acid-lowering treatment plan: Maintain the individualized uric acid-lowering treatment plan at the time of patient enrollment. Traditional uric acid-lowering treatment plans include drugs that reduce uric acid production such as febuxostat and allopurinol, and drugs that increase uric acid excretion such as benzbromarone. At the time of enrollment, the uric acid-lowering drugs were stable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Controll group | Active Comparator | The control group was treated with the standard uric acid-lowering treatment regimen alone. Uric acid-lowering treatment plan: Maintain the individualized uric acid-lowering treatment plan at the time of patient enrollment. Traditional uric acid-lowering treatment plans include drugs that reduce uric acid production such as febuxostat and allopurinol, and drugs that increase uric acid excretion such as benzbromarone. |
|
| Potassium citrate group | Experimental | On the basis of the standard uric acid-lowering treatment plan, potassium citrate was taken three times a day, 2.16g each time. |
|
| Sodium bicarbonate group | Experimental | Sodium Bicarbonate Oral Capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Bicarbonate Oral Capsule | Drug | On the basis of the standard uric acid-lowering treatment plan, sodium bicarbonate should be taken three times a day, 1.0g each time |
|
| Measure | Description | Time Frame |
|---|---|---|
| serum uric acid | From enrollment to the end of treatment at 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| gout flare | From enrollment to the end of treatment at 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| nephrolithiasis | From enrollment to the end of treatment at 48 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Miao | Contact | 021-17857540080 | my20000109@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan hospital, Fudan university | Recruiting | Shanghai | China |
all IPD collected throughout the trial. Contact the author by email after the research is completed.
Beginning 3 months and ending 3 years after the publication of results
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| ID | Term |
|---|---|
| D033461 | Hyperuricemia |
| D006073 | Gout |
| D053040 | Nephrolithiasis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
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| ID | Term |
|---|---|
| D017693 | Sodium Bicarbonate |
| D019357 | Potassium Citrate |
| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
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| Potassium Citrate Tablets | Drug | On the basis of the standard uric acid-lowering treatment plan, potassium citrate was taken three times a day, 2.16g each time |
|
| uric-acid-lowering drug | Drug | The control group was treated with the standard uric acid-lowering treatment regimen alone. Uric acid-lowering treatment plan: Maintain the individualized uric acid-lowering treatment plan at the time of patient enrollment. Traditional uric acid-lowering treatment plans include drugs that reduce uric acid production such as febuxostat and allopurinol, and drugs that increase uric acid excretion such as benzbromarone. At the time of enrollment, the uric acid-lowering drugs were stable. The treatment plan for lowering uric acid remained unchanged for 4 weeks after enrollment in the clinical study until the endpoint. |
|
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| D012216 | Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D052801 | Male Urogenital Diseases |
| D007287 |
| Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D019343 | Citric Acid |
| D002951 | Citrates |
| D014233 | Tricarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |