comparison the efficacy of tamsulosin and hydrophilic extract of Allium Jesdianum versus tamsulosin in treatment of renal colic and passage of urinary stones after Extracorporeal shock wave lithotripsy (ESWL)
comparison the efficacy of oral tamsulosin and hydrophilic extract of allium Jesdianum versus tamsulosin for treatment of renal colic and stone passage after extracorporeal shock wave lithotripsy (ESWL)
Design
In this randomized clinical trial from March to December 2018 with simple sampling methods eighty (80) patients older than 18 years old suffering from renal or ureteral stones less than 20 millimeter allocated in one of two groups.
Settings and conduct
Patients referring to ESWL unit of Shahid Beheshti hospital of Yasuj after performing ESWL by standard method and taking informed consent form entered the study.
Participants/Inclusion and exclusion criteria
patients older than 18 years old with renal and upper ureteral stones with diameter less than 20 millimeter candidate for ESWL and after taking informed consent form and approval of ethics committee will be entered the study.
Intervention groups
In first group one capsule of tamsulosin 0.4 mg will be prescribed with one glass of water every night. In the second group 1 gram of extract in the form of capsule will be prescribed in 2 divided doses with one glass of water every 12 hour with one capsule of tamsulosin 0.4 mg every night for two weeks.
Main outcome variables
efficacy of treatment according to change in the size of stone and passage of stones by KUB and ultrasonography , decreasing patients’ pain intensity before and after ESWL and during taking drugs according to visual analog scale .
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20081011001323N16
Registration date:2018-04-04, 1397/01/15
Registration timing:registered_while_recruiting
Last update:2018-04-04, 1397/01/15
Update count:0
Registration date
2018-04-04, 1397/01/15
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
Research vice chancellor , Yasuj University of Medical Sciences
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison the efficacy of tamsulosin and hydrophilic extract of Allium Jesdianum versus tamsulosin in treatment of renal colic and passage of urinary stones after Extracorporeal shock wave lithotripsy (ESWL)
Public title
comparison of tamsulosin and Allium Jesdianum in treatment of renal colic and passage of urinary stones
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age more than 18 years old
suffering from renal or upper ureteral stone less than 20 millimeter
Having informed consent form
Exclusion criteria:
presence of active infection drugs
azotemia
uncontrolled coagulopathy uncontrolled
pregnancy
hypertension
severe cardiovascular disorders
hypersensitivity to chemical or herbal drugs
Age
From 18 years old to 99 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized allocation with simple sampling method to intervention and controlled groups
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
2018-03-12, 1396/12/21
Ethics committee reference number
IR.YUMS.REC.1396.183
Health conditions studied
1
Description of health condition studied
Calculus of kidney and ureter
ICD-10 code
N20.2
ICD-10 code description
Calculus of kidney and calculus of ureter
Primary outcomes
1
Description
Passage of renal and upper ureteral stones less than 20milimeter after ESWL and receiving treatment
Timepoint
Two weeks after the lithotripsy and treatment
Method of measurement
KUB and Ultrasonography and report of patients
Secondary outcomes
1
Description
pain intensity before and after ESWL and during treatment
Timepoint
daily to two weeks after ESWL
Method of measurement
visit and examinatin and check by visual analogue scale
Intervention groups
1
Description
In first group after Extra corporeal shock wave lithotripsy(ESWL) one capsule of tamsulosin 0.4 milligram will be prescribed by one glass of water every night for two weeks.
Category
Treatment - Drugs
2
Description
in second group 1 gram of allium jesdianum extract in the form of capsule every 12 hour with one capsule of tamsulosin 0.4 milligram every night with one glass of water will be prescribed for two weeks.