Comparison of the efficacy of allium sativum and tamsulosin on pain improvement and expulsion rate of 4 to 10 mm kidney and ureteral stones in adult patients over 18 years of age
Comparison of the efficacy of allium sativum and tamsulosin on pain improvement and removal of 4 to 10 mm kidney and ureteral stones in adult patients over 18 years of age
Design
In this randomized, parallel group clinical trial from October 2018 to October 2019 with simple sampling methods eighty (80) patients older than 18 years old allocated in one of two groups and will received intervention for two weeks. .
Settings and conduct
Patients referring to Shahid Mofateh clinic of Yasuj suffering from renal or ureteral stones 4-10 millimeter allocated in one of two groups with simple sampling method. The history and physical exam and basic serum samples will be checked. In two groups it is recommended to walk and do exercise at least 30 minutes per day .Two weeks and one month later, the patients will be re-examined and KUB or ultrasonography would be performed and the success of treatment was measured and recorded according to the size of the stone and the presence of residual stones. Also pain severity of patients will be checked and recorded by Visual analogue scale (VAS) during treatment and two weeks after that.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients older than 18 years old with kidney and ureteral stones with sizes of 4- 10 mm, taking informed consent form,
Exclusion criteria: Patients with coagulation disorders, pregnant women and those with a history of herbal or medicinal allergy.
Intervention groups
Intervention group: Fresh allium sativum will be provided in form of capsule and prescribe in dosage of 40 m/kg (milligram/kilogram) per day in three divided doses after meal with one glass of water for two weeks.
Control group: Tamsulosin capsule 0.4 mg will prescribe every night with one glass of water for two weeks.
Main outcome variables
Change in the size and passage of stones ؛ pain severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20081011001323N20
Registration date:2018-11-21, 1397/08/30
Registration timing:registered_while_recruiting
Last update:2018-11-21, 1397/08/30
Update count:0
Registration date
2018-11-21, 1397/08/30
Registrant information
Name
Sadrollah Mehrabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3334 6070
Email address
dr.mehrabi@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-11, 1397/08/20
Expected recruitment end date
2019-11-11, 1398/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of allium sativum and tamsulosin on pain improvement and expulsion rate of 4 to 10 mm kidney and ureteral stones in adult patients over 18 years of age
Public title
Allium sativum and oral tamsulosin on pain improvement and expulsion of urinary stones
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than18 years old
Suffering from renal or ureteral stone less than 10 millimeter
Having informed consent form
Exclusion criteria:
Uncontrolled coagulopathy
Azotemia
Pregnancy
Presence of active urinary tract infection
Allergy to medical or herbal drugs
Suffering from severe cardiovascular or pulmonary disease
Age
From 18 years old to 99 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are allocated with simple sampling methods and random numbering table to one of each group (allium sativum or tamsulosin) and received the intervention of that group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Yasuj University of Medical Sciences, Mottahari srteet, Yasuj, Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2018-11-03, 1397/08/12
Ethics committee reference number
IR.YUMS.REC.1397.101
Health conditions studied
1
Description of health condition studied
Renal and ureteral calculus
ICD-10 code
N20.2
ICD-10 code description
Calculus of kidney with calculus of ureter
Primary outcomes
1
Description
passage of renal and ureteral stones with sizes from 4 to 10 millimeters
Timepoint
Two weeks and one month after start of treatment
Method of measurement
Perform KUB and sonography and patient report
Secondary outcomes
1
Description
The severity of pain due to stone passage
Timepoint
During the study , two weeks and one month after starting treatment
Method of measurement
With Visual Analogue Scale (VAS)
Intervention groups
1
Description
Intervention group: fresh allium sativum is produced in form of capsule and is consumed at a dose of 40 mg / kg / day (divided into three doses) after meal with a glass of water for 2 weeks.
Category
Treatment - Drugs
2
Description
Control group: Tamsulosin capsule 4 mg / day is prescribed with a glass of water every night for two weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mofateh clinic of Yasuj
Full name of responsible person
Sadrolleh Mehrabi
Street address
Shahid Mofateh clinic, Montazeri Street, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3322 4721
Email
sadrollahm@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Ali Mousavizadeh
Street address
Yasuj, Motahari St., Yasuj University of Medical Sciences, Research Deputy
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6074
Email
health.epid@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Sadrollah Mehrabi
Position
Professor, Education vice chancellor, Yasuj University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Vice chancellor for Education, Yasuj University of Medical Sciences, Mottahari Street, Yasuj, Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 33346070
Email
dr.mehrabi@yums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Sadrollah Mehrabi
Position
Professor, Education vice chancellor, Yasuj University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Vice chancellor for Education, Yasuj University of Medical Sciences, Mottahari Street, Yasuj, Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591541417
Phone
+98 74 3334 6070
Email
dr.mehrabi@yums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Sadrollah Mehrabi
Position
Professor, Fellowship of endourology and laparoscopy
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Deputy of education, Yasuj University of Medical Sciences, Mottahari Street, Yasuj, Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6070
Email
dr.mehrabi@yums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD