Determining the effect of Apium graveolens and Pimpinella anisum products on urinary tract stones
Design
Clinical trial with control and intervention groups, double blind, random sampling available
Settings and conduct
Random sampling is performed on patients who have been referred to 9Day Hospital Torbat Heydariyeh with a previous diagnosis of urinary stones.Neither analyst nor participant will be informed about group allocation.Patients in the intervention group of Ninety Apium graveolens-Pimpinella anisum 500 mg capsules produced by Sanabol Drug Company (in addition to taking the medications required for conventional medicine) were given for one month and the control group was monitored by the researcher and only their common medications ( If needed).Anise-celery capsules are taken by patients in the intervention group three times in the morning, noon and night after meals, and the researcher will monitor the correct use of the drug on a weekly basis by telephone. After one month, Ultrasonography will be performed for both groups and the size of the urinary stone will be measured in millimeters.
Participants/Inclusion and exclusion criteria
Inclusion criteria:The tendency to enter the study with kidney and bladder stones with a size equal to or less than 10 mm
Exclusion criteria: Acute kidney pain and Sensitivity to the present herbal product
Intervention groups
Intervention group : Ninety 500 mg Apium graveolens-Pimpinella anisum capsules produced by Sanabel Drug Company (in addition to the drugs required by conventional medicine) are given for one month in three shifts, morning, noon and night.
Control group : monitored by the researcher and only take their common medicine (if needed).
Main outcome variables
Urinary stone size
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160516027925N6
Registration date:2020-04-29, 1399/02/10
Registration timing:prospective
Last update:2020-04-29, 1399/02/10
Update count:0
Registration date
2020-04-29, 1399/02/10
Registrant information
Name
Amir Zoka
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3822 4395
Email address
zokaa921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-20, 1399/03/31
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Apium graveolens and Pimpinella anisum herbal product on urinary tract stones
Public title
Effect of Apium graveolens and Pimpinella anisum herbal medicine on urinary tract stones
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The tendency to enter the study with kidney and bladder stones with a size less than or equal to 10mm
Exclusion criteria:
Acute kidney pain
Sensitivity to the present herbal product
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomized (using Randomization.com site) will be divided into Two groups: A (intervention) and B (control).
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will not know which group they are in. The data analyst and the outcome assessor will also be unaware of which group are intervention or control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Torbate Heydariye University of Medical science
Street address
University of medical science, Razi Street
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
۹۵۱۶۹۱۵۱۶۹
Approval date
2020-01-24, 1398/11/04
Ethics committee reference number
IR.THUMS.REC.1398.047
Health conditions studied
1
Description of health condition studied
Urinary tract stones
ICD-10 code
N20
ICD-10 code description
Calculus of kidney and ureter
Primary outcomes
1
Description
Change of the size of the stone
Timepoint
Before and after the intervention
Method of measurement
Ultrasonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group : Ninety 500 mg Apium graveolens-Pimpinella anisum capsules produced by Sanabel Drug Company (in addition to the drugs required by conventional medicine) are given for one month in three shifts, morning, noon and night.
Category
Treatment - Other
2
Description
Control group: monitored by the researcher and only take their common medicine (if needed).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
9day hospital Torbat Heydariyeh
Full name of responsible person
Hosein Aziz
Street address
Kashani Street, 9day hospital
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
95188-31166
Phone
+98 51 5222 6016
Email
Pr@THUMS.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Hasan Azhdari Zarmehri
Street address
Razi Street
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
9516915169
Phone
+98 51 5222 6114
Email
azhdarih1@thums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Torbate-Heidaria University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Hossein Bakhtiari Dovombaygi
Position
Undergraduate Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Razi Street
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
۹۵۱۶۹۱۵۱۶۹
Phone
+98 51 5228 6064
Email
Hs.bakhtiari1998@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Hosein Azizi
Position
Non-faculty physician
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
Kashani street, 9day hospital
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
9518831166
Phone
+98 51 5222 6016
Email
azizitarin@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Hossein Bakhtiari Dovombaygi
Position
Undergraduate Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Razi Street
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
۹۵۱۶۹۱۵۱۶۹
Phone
+98 51 5228 6064
Email
Hs.bakhtiari1998@gmail.com
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