A Phase 4 interventional study of Sodium Bicarbonate Oral Capsule and Potassium Citrate Tablets in Hyperuricemia or Gout and Nephrolithiasis, sponsored by Huashan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-05-13.
Sponsored by Huashan Hospital · Phase 4, Interventional, and Treatment
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.
240 studies on the registry are indexed under Hyperuricemia; 44 are open to participants now.
This study's planned enrollment of 312 is above the median of 68 across 193 interventional studies indexed under Hyperuricemia.
Browse Hyperuricemia studies →Huashan Hospital is the lead sponsor of 247 studies on the registry; 104 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: uric-acid-lowering drug
On the basis of the standard uric acid-lowering treatment plan, potassium citrate was taken three times a day, 2.16g each time.
Drug: Potassium Citrate Tablets · Drug: uric-acid-lowering drug
Sodium Bicarbonate Oral Capsule
Drug: Sodium Bicarbonate Oral Capsule · Drug: uric-acid-lowering 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
On the basis of the standard uric acid-lowering treatment plan, potassium citrate was taken three times a day, 2.16g each time
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.
serum uric acid
Time frame: From enrollment to the end of treatment at 48 weeks
gout flare
Time frame: From enrollment to the end of treatment at 48 weeks
nephrolithiasis
Time frame: From enrollment to the end of treatment at 48 weeks
Plan to share: Yes — all IPD collected throughout the trial. Contact the author by email after the research is completed.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Beginning 3 months and ending 3 years after the publication of results
No publications or documents are linked to this record.
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Studies of the drugs tested here: Sodium Bicarbonate · Potassium Citrate