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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Intervention groups
#1
Intervention group: 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.
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.
Intervention group:Volunteer patients recieve four capsules of Z-Stone(mixtureStone (mixture of Olea europaea, Tribulus terrestires, Alhagi and Zea Mays) with a glass of water, four times a day, for a week.
گروه مداخله: بیماران روزی چهار نوبت، هر بار چهار کپسول زد-استون(شامل ترکیب برگ زیتون، خار‌خاسک، خارشتر و کاکل ذرت) به همراه یک لیوان آب به مدت یک هفته دریافت می کنند.
بیماران داوطلب روزی چهار نوبت، هر بار چهار کپسول زد-استون(شامل ترکیب برگ زیتون، خار‌خاسک، خارشتر و کاکل ذرت) به همراه یک لیوان آب به مدت یک هفته دریافت می کنند.
گروه مداخله: بیماران داوطلب روزی چهار نوبت، هر بار چهار کپسول زد-استون(شامل ترکیب برگ زیتون، خار‌خاسک، خارشتر و کاکل ذرت) به همراه یک لیوان آب به مدت یک هفته دریافت می کنند.
#2
Placebo
empty
placebo
Control group: patients recieve four capsules of starch, with a completely similar appearane to the capsules of Z-Stone, with a glass of water, four times a day, for a week.
empty
Control group: patients recieve four capsules of starch, with a completely similar appearane to the capsules of Z-Stone, with a glass of water, four times a day, for a week.
گروه کنترل:بیماران روزی چهار نوبت، هر بار ۴ کپسول نشاسته، با ظاهری کاملا مشابه کپسول زد-استون، به همراه یک لیوان آب به مدت یک هفته دریافت می کنند.
empty
گروه کنترل:بیماران روزی چهار نوبت، هر بار ۴ کپسول نشاسته، با ظاهری کاملا مشابه کپسول زد-استون، به همراه یک لیوان آب به مدت یک هفته دریافت می کنند.
Protocol summary
Study aim
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
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
Examining the number, size and location of kidney stone by sonography and CT-Scan
General information
Reason for update
The information is updated in order to changing the center of sampling, revising variables and considering the control group in this study.
Acronym
IRCT registration information
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
Registration date
2019-11-23, 1398/09/02
Registrant information
Name
Seyyed Abbas Zojaji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2717
Email address
zojajia881@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Evaluation of the effects of a Polyherbal compound in the treatment of kindney stone disease
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad university-Mashhad branch
Street address
Emam Khomeini Ave, Shahinfar Medical School
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Approval date
2019-06-26, 1398/04/05
Ethics committee reference number
IR.IAU.MSHD.REC.1398.063
Health conditions studied
1
Description of health condition studied
Kidney stone(urolithiasis)
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Kidney stone size
Timepoint
Before intervention, one month after intervention
Method of measurement
1-Sonography, 2-Computed Tomography(CT scan)
2
Description
location of kidney stone
Timepoint
Before intervention, one month after intervention
Method of measurement
1-Sonography, 2-Computed Tomography(CT scan)
3
Description
Number of kidney stone
Timepoint
Before intervention, one month after intervention
Method of measurement
1-Sonography, 2-Computed Tomography(CT scan)
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Seyyed Abbas Zojaji
Street address
Imam Reza Hospital, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
Info@zojaj.club
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Reza Khakzad Oryani
Street address
Innovative medical research center, Shahinfar university of medical science, Imam Khomeini Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 51 3225 6291
Email
IMRC@mshdiau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Zojaj Darman Tous Company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Zojaj Darman Tous Company
Full name of responsible person
Seyyed Abbas Zojaji
Position
Ph.D of Pharmacology/CEO
Latest degree
Ph.D.
Other areas of specialty/work
Medical pharmacy
Street address
Pharmaceutical Technology Incubator of Mashhad university of medical science, Buali square
City
Mashhad
Province
Razavi Khorasan
Postal code
9196773113
Phone
+98 51 3711 2611
Email
Info@zojaj.club
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zojaj Darman Tous Company
Full name of responsible person
Seyyed abbas Zojaji
Position
Ph.D of Pharmacology/CEO
Latest degree
Ph.D.
Other areas of specialty/work
Medical pharmacy
Street address
Pharmaceutical Technology Incubator of Mashhad university of medical science, Buali square
City
Mashhad
Province
Razavi Khorasan
Postal code
9196773117
Phone
+98 51 3711 2611
Email
Info@zojaj.club
Person responsible for updating data
Contact
Name of organization / entity
Zojaj Darman Tous Company
Full name of responsible person
Seyyed Abbas Zojaji
Position
Ph.D of Pharmacology/CEO
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmaceutical Technology Incubator of Mashhad university of medical science, Buali square
City
Mashhad
Province
Razavi Khorasan
Postal code
9196773117
Phone
+98 51 3711 2611
Email
info@zojaj.club
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available