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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Protocol summary
The study population includes a group of 50 patients with kidney stone disease, with kidney stone size lesser than 10 milimeters. The study is phase 2 clinical trial. The treatment period is one week. After this period, sonography will be performed. The results of measurment of hydronephrosis and kidney stone size will be compared. This study, does not have control group.
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.
The study population includes a group of 50 patientspatient with kidney stone disease, with kidney stonedisease(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. TheOne month after treatment period is one week. After this period, sonography and CT-Scan will be performed. The results of measurmentexamining size, numbr and loation of hydronephrosis and kidney stone sizestones in two groups will be compared. This study, does not have control group.
جمعیت مورد مطالعه شامل یک گروه ۵۰ نفره مبتلا به سنگ کلیه با اندازه کمتر از ۱۰ میلی متر می باشد.مطالعه در فاز دو کارآزمایی بالینی است. دوره درمان یک هفته می‌باشد. پس از یک هفته سونوگرافی انجام خواهد شد. نتایج حاصل از اندازه گیری هیدرونفروز و سنگ کلیه، قبل و بعد از مداخله، مقایسه خواهند شد. این مطالعه گروه شاهد ندارد.
جمعیت مورد مطالعه شامل ۵۰ نفر مبتلا به سنگ کلیه(با اندازه کمتر از ۱۰ میلی متر) می باشد. بیماران به طور تصادفی به دو گروه ۲۵ نفره مداخله و کنترل تقسیم خواهند شد. مطالعه در فاز دو کارآزمایی بالینی است. یک ماه پساز دوره درمان، سونوگرافی و سی تی اسکن انجام خواهد شد. نتایج حاصل از بررسی اندازه، تعداد و مکان سنگ کلیه، قبل و بعد از مداخله، در دو گروه مقایسه خواهند شد.
جمعیت مورد مطالعه شامل یک گروه ۵۰ نفرهنفر مبتلا به سنگ کلیه باکلیه(با اندازه کمتر از ۱۰ میلی متر) می باشد.مطالعهباشد. بیماران به طور تصادفی به دو گروه ۲۵ نفره مداخله و کنترل تقسیم خواهند شد. مطالعه در فاز دو کارآزمایی بالینی است. یک ماه پساز دوره درمان یک هفته می‌باشد. پس از یک هفته، سونوگرافی و سی تی اسکن انجام خواهد شد. نتایج حاصل از بررسی اندازه گیری هیدرونفروز، تعداد و مکان سنگ کلیه، قبل و بعد از مداخله، در دو گروه مقایسه خواهند شد. این مطالعه گروه شاهد ندارد.
The subjects for the study will be derived from the Army 550 Hospital, Mashhad. Hydronephrosis and kindney stone size will be assessed by sonography, before and a week after intervention.
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.
The subjects for the study will be derived from the Army 550urology section of Imam Reza Hospital, Mashhad. Hydronephrosis; and will be devided into control and intervention groups(25 patients in each group). Number, location and size of kindney stone sizestones will be assessed by sonography and CT-Scan, before and a weekmonth after intervention.
بیماران مورد نظر از بیمارستان ۵۵۰ ارتش شهر مشهد، انتخاب خواهند شد. در ابتدا و سپس یک هفته بعد از انجام مداخله مقدار هیدرونفروز کلیوی و اندازه سنگ کلیه با سونوگرافی ارزیابی خواهند شد.
بیماران مورد نظر از بخش اورولوژی بیمارستان امام رضا شهر مشهد، انتخاب و به صورت تصادفی دو گروه مداخله وکنترل(هر یک، ۲۵ نفر) تقسیم می شوند. در ابتدا و سپس یک ماه بعد از انجام مداخله، تعداد، مکان و اندازه سنگ کلیه با سونوگرافی ارزیابی خواهند شد.
بیماران مورد نظر از بخش اورولوژی بیمارستان ۵۵۰ ارتشامام رضا شهر مشهد، انتخاب خواهند شدو به صورت تصادفی دو گروه مداخله وکنترل(هر یک، ۲۵ نفر) تقسیم می شوند. در ابتدا و سپس یک هفتهماه بعد از انجام مداخله مقدار هیدرونفروز کلیوی، تعداد، مکان و اندازه سنگ کلیه با سونوگرافی ارزیابی خواهند شد.
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.
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.
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.
بیماران به مدت یک هفته، روزانه ۴ بار و هر بار ۴ کپسول زد استون معادل ۲ گرم ترکیب برگ زیتون، خار‌خاسک، خارشتر و کاکل ذرت به همراه یک لیوان آب، دریافت می‌کنند.
بیماران به مدت یک هفته، روزانه ۴ بار و هر بار ۴ کپسول زد استون معادل ۲ گرم ترکیب برگ زیتون، خار‌خاسک، خارشتر و کاکل ذرت به همراه یک لیوان آب، دریافت می‌کنند.
گروه مداخله با همین رویه ، کپسول نشاسته(با ظاهری کاملا مشابه زد-استون) به عنوان دارونما دریافت خواهد کرد.
بیماران به مدت یک هفته، روزانه ۴ بار و هر بار ۴ کپسول زد استون معادل ۲ گرم ترکیب برگ زیتون، خار‌خاسک، خارشتر و کاکل ذرت به همراه یک لیوان آب، دریافت می‌کنند. گروه مداخله با همین رویه ، کپسول نشاسته(با ظاهری کاملا مشابه زد-استون) به عنوان دارونما دریافت خواهد کرد.
Measurement of kidney hydronephrosis, evaluation of changes in Kidney stone size by sonography and examining the effects of the herbal compound on reducing them.
Examining the number, size and location of kidney stone by sonography and CT-Scan
MeasurementExamining the number, size and location of kidney hydronephrosis, evaluation of changes in Kidney stone size by sonography and examining the effects of the herbal compound on reducing them.CT-Scan
اندازه‌گیری هیدرونفروز کلیوی، ارزیابی تغییرات اندازه سنگ کلیه با سونوگرافی و بررسی اثر ترکیب گیاهی بر کاهش آنها
بررسی تعداد،اندازه و مکان سنگ کلیه با استفاده از سونوگرافی و سی تی اسکن
بررسی تعداد،اندازه‌گیری هیدرونفروز کلیوی، ارزیابی تغییرات اندازه و مکان سنگ کلیه با استفاده از سونوگرافی و بررسی اثر ترکیب گیاهی بر کاهش آنهاسی تی اسکن
General information
Not used
Used
nusedused
Single
Parallel
singlparal
2
N/A
2na
empty
The information is updated in order to changing the center of sampling, revising variables and considering the control group in this study.
The information is updated in order to changing the center of sampling, revising variables and considering the control group in this study.
empty
به منظور تغییر محل نمونه گیری، تجدیدنظر درمورد متغیرها و درنظر گرفتن گروه کنترل در این مطالعه، به روز رسانی اطلاعات انجام گرفت.
به منظور تغییر محل نمونه گیری، تجدیدنظر درمورد متغیرها و درنظر گرفتن گروه کنترل در این مطالعه، به روز رسانی اطلاعات انجام گرفت.
Primary outcomes
#1
Before intervention, one week after intervention
Before intervention, one month after intervention
Before intervention, one weekmonth after intervention
قبل از مداخله، یک هفته پس از مداخله
قبل از مداخله، یک ماه پس از مداخله
قبل از مداخله، یک هفتهماه پس از مداخله
Sonography
1-Sonography, 2-Computed Tomography(CT scan)
1-Sonography, 2-Computed Tomography(CT scan)
سونوگرافی
۲-سونوگرافی ۲-مقطع نگاری رایانه ای(سی تی اسکن)
۲-سونوگرافی ۲-مقطع نگاری رایانه ای(سی تی اسکن)
#2
Hydronephrosis Measurement
location of kidney stone
Hydronephrosis Measurementlocation of kidney stone
اندازه گیری هیدرونفروز کلیوی
مکان سنگ کلیه
اندازه گیری هیدرونفروز کلیویمکان سنگ کلیه
Before intervention, one week after intervention
Before intervention, one month after intervention
Before intervention, one weekmonth after intervention
قبل از مداخله، یک هفته پس از مداخله
قبل از مداخله، یک ماه پس از مداخله
قبل از مداخله، یک هفتهماه پس از مداخله
Sonography
1-Sonography, 2-Computed Tomography(CT scan)
1-Sonography, 2-Computed Tomography(CT scan)
سونوگرافی
۱-سونوگرافی ۲-مقطع نگاری رایانه ای(سی تی اسکن)
۱-سونوگرافی ۲-مقطع نگاری رایانه ای(سی تی اسکن)
#3
empty
Number of kidney stone
Number of kidney stone
empty
تعداد سنگ کلیه
تعداد سنگ کلیه
empty
Before intervention, one month after intervention
Before intervention, one month after intervention
empty
قبل از مداخله، یک ماه پس از مداخله
قبل از مداخله، یک ماه پس از مداخله
empty
1-Sonography, 2-Computed Tomography(CT scan)
1-Sonography, 2-Computed Tomography(CT scan)
empty
۱-سونوگرافی ۲-مقطع نگاری رایانه ای(سی تی اسکن)
۱-سونوگرافی ۲-مقطع نگاری رایانه ای(سی تی اسکن)
Intervention groups
#1
empty
Placebo
placebo
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.
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
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.
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.
Recruitment centers
#1
Name of recruitment center - English: Army 550 Hospital
Name of recruitment center - Persian: بیمارستان 550 ارتش
Full name of responsible person - English: Seyyed Abbas Zojaji
Full name of responsible person - Persian: سید عباس زجاجی
Street address - English: Bahar Ave
Street address - Persian: خیابان بهار
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 31908205-051
Phone: +98 51 3859 1052
Fax:
Email: Info@zojaj.club
Web page address:
Name of recruitment center - English: Imam Reza hospital
Name of recruitment center - Persian: بیمارستان امام رضا
Full name of responsible person - English: Seyyed Abbas Zojaji
Full name of responsible person - Persian: سید عباس زجاجی
Street address - English: Imam Reza Hospital, Imam Reza Square
Street address - Persian: میدان امام رضا، بیمارستان امام رضا
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9137913316
Phone: +98 51 3854 3031
Fax:
Email: Info@zojaj.club
Web page address:
Name of recruitment center - English: Army 550 HospitalImam Reza hospital Name of recruitment center - Persian: بیمارستان 550 ارتشامام رضا Full name of responsible person - English: Seyyed Abbas Zojaji Full name of responsible person - Persian: سید عباس زجاجی Street address - English: Bahar AveImam Reza Hospital, Imam Reza Square Street address - Persian: خیابان بهارمیدان امام رضا، بیمارستان امام رضا City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 31908205-0519137913316 Phone: +98 51 3859 10523854 3031 Fax: Email: Info@zojaj.club Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Zojaj Darman Tous Company
Name of organization / entity - Persian: شرکت زجاج درمان طوس
Full name of responsible person - English: Seyyed Abbas Zojaji
Full name of responsible person - Persian: سید عباس زجاجی
Street address - English: Pharmaceutical Technology Incubator of Mashhad university of medical science, Buali square
Street address - Persian: مشهد، میدان بوعلی، مرکز رشد واحد های فناوری دانشگاه علوم پزشکی مشهد
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9196773117
Phone: +98 51 3711 2611
Fax:
Email: info@zojaj.club
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mohammad Reza Khakzad Oryani
Full name of responsible person - Persian: محمدرضا خاكزاد عريانی
Street address - English: Innovative medical research center, Shahinfar university of medical science, Imam Khomeini Ave, Mashhad
Street address - Persian: مشهد، خیابان امام خميني، دانشكده پزشكي شاهين فر، مركز تحقيقات نوآوري پزشكي
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9187147578
Phone: +98 51 3225 6291
Fax:
Email: IMRC@mshdiau.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Zojaj Darman Tous Company Name of organization / entity - Persian: شرکت زجاج درمان طوس Full name of responsible person - English: Seyyed Abbas ZojajiMohammad Reza Khakzad Oryani Full name of responsible person - Persian: سید عباس زجاجیمحمدرضا خاكزاد عريانی Street address - English: Pharmaceutical Technology Incubator of MashhadInnovative medical research center, Shahinfar university of medical science, Buali squareImam Khomeini Ave, Mashhad Street address - Persian: مشهد، میدان بوعلیخیابان امام خميني، مرکز رشد واحد های فناوری دانشگاه علوم پزشکی مشهددانشكده پزشكي شاهين فر، مركز تحقيقات نوآوري پزشكي City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 91967731179187147578 Phone: +98 51 3711 26113225 6291 Fax: Email: infoIMRC@zojaj.clubmshdiau.ac.ir Web page address:
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:2020-02-06, 1398/11/17
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
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.
Category
Treatment - Drugs
2
Description
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.
Category
Placebo
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