Comparison effect of leaf of Biarum carsuchrum and oral tamsulosin on pain improvement and passage rate of renal and ureteral stones sized 4-10 millimeter
Comparison effect of Biarum carsuchrum leaf and tamsulosin on pain improvement and passage of renal and ureteral stones sized 4-10 millimeter
Design
In this randomized, parallel group clinical trial from January 2019 to December 2019 with simple sampling methods eighty (80) patients older than 18 years old allocated in one of two groups (Biarum carsuchrum leaf or tamsulosin) and will received intervention for two weeks.
Settings and conduct
Patients referring to Shahid Mofateh clinic of Yasuj suffering from renal or ureteral stones with sizes of 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:Age more than18 years old suffering from renal or ureteral stone less than 10 millimeter, having informed consent form
Exclusion criteria:Uncontrolled coagulopathy , Pregnancy, Azotemia, Allergy to medical or herbal drugs, Severe cardiovascular or pulmonary disease
Intervention groups
Intervention group:Biarum carsuchrum leaf in form of capsule will prepare and prescribed in divided dosage of 3 capsule of 300 mg per day 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:IRCT20081011001323N21
Registration date:2019-02-07, 1397/11/18
Registration timing:registered_while_recruiting
Last update:2019-02-07, 1397/11/18
Update count:0
Registration date
2019-02-07, 1397/11/18
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
2019-01-30, 1397/11/10
Expected recruitment end date
2019-12-01, 1398/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of leaf of Biarum carsuchrum and oral tamsulosin on pain improvement and passage rate of renal and ureteral stones sized 4-10 millimeter
Public title
Comparison effect of Biarum carsuchrum and tamsulosin on 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
Pregnancy
Azotemia
Allergy to medical or herbal drugs
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 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
2019-01-27, 1397/11/07
Ethics committee reference number
IR.YUMS.REC.1397.130
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 with sizes from 4-10 millimeter
Timepoint
Two weeks and one month after start of treatment
Method of measurement
Taking KUB and Ultrasonography and report of patients
2
Description
Pain severity score due to passage of stones
Timepoint
During study and two weeks and one month after start of treatment
Method of measurement
With Visual Analogue Scale(VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Biarum carsuchrum leaf in form of capsule will prepare and prescribed in divided dosage of 3 capsule of 300 mg per day after meal with one glass of water for two 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.