Urinary Calculi
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: [1] Aged 18 to 70 years (inclusive); [2] Diagnosed with renal calculi (stone diameter = 10 mm) and willing to receive conservative treatment; [3] Adequate renal function; for patients with hydronephrosis, the degree of hydronephrosis must be mild or lower; [4] Signed informed consent.
Exclusion criteria
Exclusion criteria: [1] Pregnant or lactating women, and those planning to become pregnant during the trial period; [2] Patients with severe cardiac, hepatic, or renal insufficiency, malignant tumors, or psychiatric disorders; [3] Known or suspected allergy to the investigational product; [4] Patients with acute obstructive oliguria, anuria, or hematuria; [5] Patients with renal abnormalities, solitary kidney, or transplanted kidney; [6] Use of medications that may affect urinary calculi within 1 week prior to screening or planned use during the trial period; [7] Poor compliance as judged by the investigator, or any other condition that the investigator deems unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maximum diameter of renal calculi; | — |
Secondary
| Measure | Time frame |
|---|---|
| bladder calculi;urethral calculi;serum total cholesterol;serum total bilirubin;alanine aminotransferase (ALT);aspartate aminotransferase (AST);uric acid;pain scale ; | — |
Countries
China
Contacts
Kunshan First People's Hospital