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Assess the efficacy and safety of potassium citrate extended-release tablets on Urolithiasis formation or recurrence.
This study takes "Rate of stone recurrence" as primary outcome measure, by random, blank control, and multicenter clinical trial design method, assess the efficacy and safety of potassium citrate extended-release tablets on Urolithiasis formation or recurrence, provide evidence for drug re-registration, and observe its efficacy on Urinary calculi such as renal tubular acidosis with calcium stone, and uric acid stones with or without calcium stone, urinary tract stone of effectiveness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Potassium Citrate Extended-release Tablets |
|
| Blank control group | No Intervention | Subjects do not take the investigational product |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Potassium Citrate Extended-release Tablets | Drug | Daily 3.24g, Po ,Tid, each 1.08g/tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Urolithiasis recurrence | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Time of stone recurrence | through study completion, an average of 1 year | |
| The changes of urine citric acid content compared with baseline | through study completion, an average of 1 year | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhangqun YE, M.D. | Contact | (+86)13507191761 | zhangqun_ye@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhangqun YE, M.D. | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fifth Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25881654 | Background | Sfoungaristos S, Gofrit ON, Yutkin V, Pode D, Duvdevani M. Prevention of renal stone disease recurrence. A systematic review of contemporary pharmaceutical options. Expert Opin Pharmacother. 2015 Jun;16(8):1209-18. doi: 10.1517/14656566.2015.1037740. Epub 2015 Apr 16. | |
| 12028622 | Background | Soygur T, Akbay A, Kupeli S. Effect of potassium citrate therapy on stone recurrence and residual fragments after shockwave lithotripsy in lower caliceal calcium oxalate urolithiasis: a randomized controlled trial. J Endourol. 2002 Apr;16(3):149-52. doi: 10.1089/089277902753716098. |
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| ID | Term |
|---|---|
| D052878 | Urolithiasis |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| The changes of Urine pH value compared with baseline |
| through study completion, an average of 1 year |
| The Second Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | China |
|
| Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430030 | China |
|
| Wuhan No.1 Hospital(Wuhan Integrated TCM & Western Medicine Hospital) | Active, not recruiting | Wuhan | Hubei | China |
| Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | China |
|
| Zhejiang Xiaoshan Hospital | Recruiting | Hangzhou | Zhejiang | China |
|
| 10210371 | Background | Lee YH, Huang WC, Tsai JY, Huang JK. The efficacy of potassium citrate based medical prophylaxis for preventing upper urinary tract calculi: a midterm followup study. J Urol. 1999 May;161(5):1453-7. |
| 20576821 | Background | Fabris A, Lupo A, Bernich P, Abaterusso C, Marchionna N, Nouvenne A, Gambaro G. Long-term treatment with potassium citrate and renal stones in medullary sponge kidney. Clin J Am Soc Nephrol. 2010 Sep;5(9):1663-8. doi: 10.2215/CJN.00220110. Epub 2010 Jun 24. |
| 17726345 | Background | Bartoletti R, Cai T, Mondaini N, Melone F, Travaglini F, Carini M, Rizzo M. Epidemiology and risk factors in urolithiasis. Urol Int. 2007;79 Suppl 1:3-7. doi: 10.1159/000104434. |
| D052801 | Male Urogenital Diseases |