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
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 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.
Settings and conduct
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.
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.
Main outcome variables
Measurement of kidney hydronephrosis, evaluation of changes in Kidney stone size by sonography and examining the effects of the herbal compound on reducing them.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151230025772N6
Registration date:2019-11-23, 1398/09/02
Registration timing:registered_while_recruiting
Last update:2019-11-23, 1398/09/02
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
2
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
Not used
Assignment
Single
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 week after intervention
Method of measurement
Sonography
2
Description
Hydronephrosis Measurement
Timepoint
Before intervention, one week after intervention
Method of measurement
Sonography
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
Recruitment centers
1
Recruitment center
Name of recruitment center
Army 550 Hospital
Full name of responsible person
Seyyed Abbas Zojaji
Street address
Bahar Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
31908205-051
Phone
+98 51 3859 1052
Email
Info@zojaj.club
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zojaj Darman Tous Company
Full name of responsible person
Seyyed Abbas Zojaji
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
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