Comparison of the efficacy of oral Pejanum harmala seeds and tamsulosin on pain improvement and expulsion of renal and ureteral stones sized6-10 millimeter in patients older than 18 years old
Comparison of the efficacy of oral Pejanum harmala seeds and tamsulosin on pain improvement and expulsion of renal and ureteral stones sized 6-10 millimeter in patients older than 18 years old
Design
In this randomized, parallel group clinical trial from March 2018 to February 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 5-10 millimeter with simple sampling method allocated in one of two groups.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 .One and three months later, the patients will be re-examined and KUB or ultrasonography would be performed and the success the treatment was measured and recorded according to the size of the stone and the presence of remaining gems.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 sized 6- 10 mm , taking informed consent form , approval of the ethics committee of university
Exclusion criteria: Patients with coagulopathy, pregnant ladies and those that have history of herbal or medicinal allergy .
Intervention groups
Intervention group: Pejanum Harmala seeds will be provided in form of capsule and prescribe in dosage of 50 m/kg(milligram/kilogram) per day single dose with one glass of water for two weeks.
Control group: Tamsulosin capsule .4 mg will prescribed 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:IRCT20081011001323N17
Registration date:2018-06-25, 1397/04/04
Registration timing:registered_while_recruiting
Last update:2018-06-25, 1397/04/04
Update count:0
Registration date
2018-06-25, 1397/04/04
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
2018-03-21, 1397/01/01
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 the efficacy of oral Pejanum harmala seeds and tamsulosin on pain improvement and expulsion of renal and ureteral stones sized6-10 millimeter in patients older than 18 years old
Public title
Efficacy of Pejanum harmala seeds and tamsulosin on renal and ureteral stones
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age more than18 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 18 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 and random numbering tableto 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
2018-03-11, 1396/12/20
Ethics committee reference number
IR.YUMS.REC.1396.120
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 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
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: Pejanum Harmala seeds in form of capsule and prescribed in dosage of 50 m/kg(milligram/kilogram) per day single dose with one glass of water for two weeks.
Category
Treatment - Drugs
2
Description
Control group: Tamsulosin capsule .4 mg prescribed every night with one glass of water for two weeks.