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Study aim
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Evaluating effect of the oral solution with five herbal extracts in the treatment of urolitiasis
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Design
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Two arm parallel group randomized double-blind placebo-controlled clinical trial with sample size of 58 patients in each group with simple randomization method
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Settings and conduct
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Patients are selected from those referred to the clinic of Al-Zahra Hospital. Participants are randomly assigned to either drug or placebo groups. Prior to intervention, patients in both groups will be sampled for a 24-hour urine sample and urine volume, calcium, sodium, citrate, oxalate, urea, creatinine, uric acid and cystine and urine pH will be determined. The number and size of stones will be determined per patient. For drug group, the herbal solution will be administered at 60 drops thrice daily, and for the placebo group, the placebo solution will be given for 4 weeks. The changes of mentioned variables as well as complete expulsion of stone will be evaluated at the end of intervention. The patients and prescribing physician will be blind to the type of intervention; because, drug and placebo solutions will be prepared in similar bottles by the pharmaceutical company.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: age over 18; symptomatic or asymptomatic urinary tract stones; Stone size of 10 mm or less. Exclusion criteria: having malignancy with bone metastasis, hyperthyroidism, hyperparathyroidism, psychosis, renal dysfunction, gout or hyperuricemia; use of other traditional products and complementary medicine used in the treatment of urolitiasis from one week before the intervention
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Intervention groups
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Intervention group: herbal solution, 60 drops 3 times daily concurrent with standard treatment
Control group: placebo solution 60 drops 3 times daily concurrent with standard treatment
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Main outcome variables
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stone size, number of people with complete stone expulsion