comparison of hydrophilic extract of Alhagi maurorum and Hydrochlorothiazide in treatment of kidney and ureteral stones sized 4_10mm in patients older than 15 years old
comparison efficacy of hydrophilic extract ofAlhagi maurorum and Hydrochlorothiazide in treatment of kidney and ureteral stones (4_10mm) in Shahid Mofateh clinic of Yasuj in 2018_ 2019
Design
In this randomized clinical trial from February 2018to 2019 with simple sampling methods eighty (80) patients older than 15years old suffering from renal or ureteral stones sized 4-10 millimeter with simple sampling method allocated in one of two groups.
Settings and conduct
Patients referring to Shahid Mofateh clinic of Yasuj sized 4-10 millimeter after taking informed consent form entered the study.
Participants/Inclusion and exclusion criteria
Patients older than 15 years old with kidney and ureteral stones sized 5- 10 mm after taking informed consent form and approval of the ethics committee included in the study . Patients with severe cardiovascular and pulmonary disease, azotemia, urinary tract infection, coagulopathy, pregnant ladies and those that have i history of herbal or medicinal allergy don't enter the study.
Intervention groups
In first group one tablet of hydrochlorothiazide 25 mg will prescribed every 12 hour with one glass of water for two weeks. In the second group 1gram of extract in the form of capsule will prescribed in 2 divided doses with one glass of water every 12 hour 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 before and after ESWL and during taking drugs till two week after intervention
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20081011001323N14
Registration date:2018-03-10, 1396/12/19
Registration timing:registered_while_recruiting
Last update:2018-03-10, 1396/12/19
Update count:0
Registration date
2018-03-10, 1396/12/19
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
2018-02-20, 1396/12/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of hydrophilic extract of Alhagi maurorum and Hydrochlorothiazide in treatment of kidney and ureteral stones sized 4_10mm in patients older than 15 years old
Public title
Comparison of Alhagi maurorum and Hydrochlorothiazide in treatment of kidney and ureteral stones
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age older than 15 years
have renal or ureteral stones between 4-10 millimeter
Have the consent to enter the study
Exclusion criteria:
Azotemia
Pregnancy
Presence of active urinary tract infection
Allergy to medical or herbal drugs
Severe cardiovascular or pulmonary disease
Uncontrolled coagulopathy
Age
From 15 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
2018-02-07, 1396/11/18
Ethics committee reference number
IR.YUMS.REC.1396.178
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
Expulsion of renal and ureteral stones sized 5-10 milimeter
Timepoint
Two weeks after the lithotripsy and treatment
Method of measurement
KUB and Ultrasonography and report of patients
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Capsule of Alhagi maurorum 500 miligram use with a glass of water every 12 hours for two weeks.
Category
Treatment - Drugs
2
Description
Control group: Hydrochlorothiazide Tablets 25 miligram every 12 hour with a glass of water for will used fortwo weeks.