Protocol summary
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Study aim
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Investigating the herbal combination of olea europaea,tribulus terrestris Alhagi and zea mays(Z-Stone capsule) effects on reducing the formation of kidney stone or increasing the speed of stone excertion
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Design
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The study population includes 50 patient with kidney stone disease(stone size lesser than 10 milimeters). Patients will be devided into control and intervention group by chance(25 patients in each group). The study is phase 2 clinical trial. One month after treatment period, sonography and CT-Scan will be performed. The results of examining size, numbr and loation of stones in two groups will be compared.
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Settings and conduct
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The subjects for the study will be derived from the urology section of Imam Reza Hospital, Mashhad; and will be devided into control and intervention groups(25 patients in each group). Number, location and size of kindney stones will be assessed by sonography and CT-Scan, before and a month after intervention.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: the desire to participate in the study; Patients with kidney stone; Stone size smaller than 10 milimeters; Exclusion criteria: history of kidney transplantation or other kidney diseases
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Intervention groups
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The patients recieve Z-Stone capsule equivalant to 2 grams mixture of olea europaea,tribulus terrestris Alhagi and zea mays with a glass of water, four times a day, each time 4 capsules, for a week. Control group recieve starch capsules(with a completley similar appearance to the Z-Stone) as placebo in the same way with intervention group.
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Main outcome variables
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Examining the number, size and location of kidney stone by sonography and CT-Scan
General information
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Reason for update
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The information is updated in order to changing the center of sampling, revising variables and considering the control group in this study.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20151230025772N6
Registration date:
2019-11-23, 1398/09/02
Registration timing:
registered_while_recruiting
Last update:
2020-08-18, 1399/05/28
Update count:
2
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Registration date
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2019-11-23, 1398/09/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-10-23, 1398/08/01
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Expected recruitment end date
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2020-10-22, 1399/08/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Investigating the herbal combination of Olea europaea leaf, Tribulus terrestris, Alhagi and zea mays on patients with kidney stone: a pre- and post-treatment comparative study
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Public title
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Evaluation of the effects of a Polyherbal compound in the treatment of kindney stone disease
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
The desire to participate in the study
Patients with kidney stone
Stone size lesser than 10 milimeters
Exclusion criteria:
Kidney tranplantation or other kidney diseases
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Age
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No age limit
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-06-26, 1398/04/05
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Ethics committee reference number
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IR.IAU.MSHD.REC.1398.063
Health conditions studied
1
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Description of health condition studied
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Kidney stone(urolithiasis)
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Kidney stone size
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Timepoint
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Before intervention, one month after intervention
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Method of measurement
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1-Sonography, 2-Computed Tomography(CT scan)
2
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Description
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location of kidney stone
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Timepoint
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Before intervention, one month after intervention
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Method of measurement
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1-Sonography, 2-Computed Tomography(CT scan)
3
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Description
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Number of kidney stone
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Timepoint
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Before intervention, one month after intervention
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Method of measurement
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1-Sonography, 2-Computed Tomography(CT scan)
Intervention groups
1
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Description
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Volunteer patients recieve four capsules of Z-Stone (mixture of Olea europaea, Tribulus terrestires, Alhagi and Zea Mays) with a glass of water, four times a day, for a week.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Zojaj Darman Tous Company
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Industry
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available