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A single-center prospective randomized controlled clinical study on the prevention of calcium oxalate stone formation by oxalate degrading enzyme combined with vitamin E and B6

A single-center prospective randomized controlled clinical study on the prevention of calcium oxalate stone formation by oxalate degrading enzyme combined with vitamin E and B6

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032553
Enrollment
Unknown
Registered
2020-05-02
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-07-27

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

Conditions

calcium oxalate urinary stone

Interventions

Drug combination group:Combined with oxalic acid degrading enzyme and vitamin B6, vitamin E
Oxalic acid degrading enzyme treatment group:Take oxalate degrading enzyme
Vitamin treatment group:Take vitamins

Sponsors

Department of Urology, Wuming Hospital Affiliated to Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients who agree to participate in this clinical trial and sign informed consent. 2. Age: 18-75, regardless of gender. 3. Patients with double J tube after urolithiasis surgery. 4. The stone composition was determined by the infrared spectrum automatic analyzer to be calcium oxalate stone (or mixed stone with calcium oxalate stone as the main component). 5. Good medication compliance and long term follow-up. 6. Patients who have not taken corresponding drugs to prevent recurrence of calcium oxalate stones after calculus surgery.

Exclusion criteria

Exclusion criteria: 1. Severe abnormalities of liver or renal function, middle or severe hydroureteral hydronephrosis, or ureteral stricture; 2. Patients with uncontrolled systemic diseases and severe urinary tract infection and infectious stones; 3. Severe renal diseases (glomerulonephritis, renal failure, renal tumor); 4. Patients with intolerance to oral vitamin E, B6 and oxalic acid degrading enzyme; 5. Pregnant or nursing women; 6. Patients with other serious diseases who are likely to die during treatment and follow-up; 7. Other ineligible patients as determined by the investigator.

Design outcomes

Primary

MeasureTime frame
The number of calcium oxalate crystals in urine;DJ tube weight gain;

Countries

china

Contacts

Public ContactTang Yong

Department of Urology, Wuming Hospital Affiliated to Guangxi Medical University

cruisett@126.com+86 15877183968

Outcome results

None listed

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