study of efficacy &side effects of oral cystone & hydrochlorothiazide in treatment of patients older than 15 years old suffering from kidney& ureteral calculi
comparison efficacy of oral cystone and Hydrochlorothiazide in treatment of kidney and ureteral stones (5_10mm) in Shahid Mofateh clinic of Yasuj in 2018_ 2019
Design
In this randomized ,parallel group clinical trial from January 2018 to January 2019 with simple sampling methods eighty (80) patients older than 15 years old allocated in one of two groups and received intervention for one months .
Settings and conduct
Patients referring to Shahid Mofateh clinic of Yasuj suffering from renal or ureteral stones 5-10 millimeter with simple sampling method allocated in one of two groups.All patients have history and physical exam and basic serum samples including renal function tests(BUN ,Cr),urine analysis and culture will be checked from all of them. In two groups use oral analgesic for pain relief and in the failure of analgesic or indication of intervention standard treatment will be done. It is also recommended that at least 30 minutes of exercise and walking will be done per day .One and three months later, the patients were re-examined and KUB or ultrasonography was performed and the success of the treatment was measured and recorded according to the size of the stone and the presence of remaining gems.
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
intervention group: 2 tablet of oral cystone every 12 hours with a glass of water for one month
Control group: Hydrochlorothiazide Tablets 25 milligram every 12 hour with a glass of water for one month
Main outcome variables
change in the size and passage of stones
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20081011001323N15
Registration date:2018-03-14, 1396/12/23
Registration timing:registered_while_recruiting
Last update:2018-03-14, 1396/12/23
Update count:0
Registration date
2018-03-14, 1396/12/23
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
2018-01-21, 1396/11/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
study of efficacy &side effects of oral cystone & hydrochlorothiazide in treatment of patients older than 15 years old suffering from kidney& ureteral calculi
Public title
comparison of cystone & hydrochlorothiazide in treatment of kidney stone
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age more than15 years old
suffering from renal or upper 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
Severe cardiovascular or pulmonary disease
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
Patients are allocated with simple sampling methods to one of each group 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
2018-01-10, 1396/10/20
Ethics committee reference number
IR.YUMS.REC.1396.156
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 with calculus of ureter
Primary outcomes
1
Description
Passage of renal and upper ureteral stones sized 5-10 milimeter
Timepoint
Two weeks and one month after start of treatment
Method of measurement
Taking KUB and Ultrasonography and report of patients
Secondary outcomes
1
Description
development of side effects
Timepoint
from start of treatment to one month later
Method of measurement
according to history and physical exam and patient report
Intervention groups
1
Description
Intervention group: Cystone Tablets take 2 tablets with one glass of water every 12 hours for one month
Category
Treatment - Drugs
2
Description
Control group: Hydrochlorothiazide Tablets 25 miligram every 12 hour with a glass of water for one month