A human clinical trial of an Allium jesdianum formulation on kidney stones

Phase 3

• Conditions: Oxalate urinary stones.; Calculus of kidney; N20.0

• Registration Number: IRCT20240712062398N1
• Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Symptomatic or asymptomatic urinary tract stones
Stone size equal to 10 mm or less
Absence of malignancy with bone metastasis
Not suffering from hyperthyroidism, hyperparathyroidism, psychosis or kidney dysfunction (creatinine above 1.4 mg/dL)
Not having a structural disorder of the urinary tract or a urinary tract infection
No gout or hyperuricemia
Not using other traditional products and complementary medicine used in the treatment of urinary stones from one week before the intervention
Absence of pregnancy and breastfeeding

Exclusion Criteria

Non-compliance with medication orders for more than 1 week
Allergy to any component of the herbal product
The need for hospitalization due to the severity of symptoms during the study
The need for surgery and lithotripsy during the study
Urinary tract infection during the study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percentage of stone size change. Timepoint: Before and after the intervention. Method of measurement: with ultrasound based on millimeter units.;Concentration of calcium, sodium, citrate, oxalate, urea, creatinine, uric acid and cystine, phosphorus in urine. Timepoint: Before and after the intervention. Method of measurement: mg/dl.;Number of people with stone removal. Timepoint: Before and after the intervention. Method of measurement: number.