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IRCT20191212045709N1 IRCT 2020-09-29 Shiraz University of Medical Sciences Library study of kidney stone dissolving medicaments in Persian medicine and evaluation of a related multi-ingredient formulation in dissolving calcium kidneystones; a double-blind randomized clinical trial Library study of kidney stone dissolving medicaments in Persian medicine and evaluation of a related multi-ingredient formulation in dissolving calcium kidneystones; a double-blind randomized clinical trial 2020-01-15 anticipated 60 Complete https://irct.ir/trial/44964 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A total of 60 patients were randomly divided in to two groups of 30 each in a randomized double-blind placebo-controlled design using permuted block randomization method. The sample size and randomization were done by a computer- generated statistical program. Minimum sample size for each group was 13 patients. All patients received either 2 capsules of drug or identical-looking placebos at a dose of 2 capsules once daily for a period of 6 weeks, Blinding description: The study will be a double blind trial and only the evaluator knows the results and the code of the drug or placebo group.The capsules of the drug group and the placebo are quite similar in appearance.The drug and placebo groups will be separated by receiving a code. 3 renal stone. The intervention group consumes 2 capsules (one in the morning and one at night) of freeze dried water extract of 6 plants including: Tribulus terrestris-Foeniculum vulgare-Pimpinella anisum- Cucumis sativus-Cucurbita pepo-Apium graveolens. the control group consumes 2 capsules of wheat flour as placebo daily. Blood sample and 24 hours urine of patients will analized at the beginning and end of the study and the imaging will be done for analizing the size and number of stones.. Yes - There is a plan to make this available What will be shared: JUST THE RESULTS WILL BE PUBLISHED When: AT THE END OF THE STUDY To whom: UNIVERSITIES Conditions: SCIENTIFIC RESEARCH Where to obtain: ZARM@SUMS.AC.IR How to obtain: CONTACT ZARM@SUMS.AC.IR Comments:
public MM ZARSHENAS
SHIRAZ FACULTY OF PHARMACY
SHIRAZ Iran (Islamic Republic of) 713451583 +98 917 711 3491 ZARM@SUMS.AC.IR Shiraz University of Medical Sciences scientific MM ZARSHENAS
FACULTY OF PHARMACY SHIRAZ
SHIRAZ Iran (Islamic Republic of) 7۱۴۶۸۶۴۶۸۵ +98 71 3242 6122 ZARM@SUMS.AC.IR Shiraz University of Medical Sciences Iran (Islamic Republic of) Age 18 years and older Calcium kidney stones with a size of 5 mm or more based on imaging results Lack of confirmed history of acute renal failure Lack of confirmed history of chronic kidney disease having no present urinary tract infection no concurrent use of medications including:®Sankol، ®Rowatinex and Cystone® no pregnancy or breast feeding 18 years 65 years Both Age 18 years and older Calcium kidney stones with a size of 5 mm or more based on imaging results Lack of confirmed history of acute renal failure Lack of confirmed history of chronic kidney disease having no present urinary tract infection no concurrent use of medications including:®Sankol، ®Rowatinex and Cystone® no pregnancy or breast feeding Treatment - Drugs The intervention group consumes 2 capsules (one in the morning and one at night) of freeze dried water extract of 6 plants including: Tribulus terrestris-Foeniculum vulgare-Pimpinella anisum- Cucumis sativus-Cucurbita pepo-Apium graveolens. the control group consumes 2 capsules of wheat flour as placebo daily. Blood sample and 24 hours urine of patients will analized at the beginning and end of the study and the imaging will be done for analizing the size and number of stones. Liver function test- renal function test-Ca and P serum level, urine analysis, 24 hour urine volume and stone diameter. Timepoint: At the beginning of the study and one month after the end of the course of medication. Method of measurement: KUB- URINE ANALYSIS-BLOOD ANALYSIS. Shiraz University of Medical Sciences Approved 2019-11-06 Ethics committee of Shiraz University of Medical Sciences anvari str- zand blvd- shiraz shiraz Fars Iran (Islamic Republic of)