Comparison effect of a combined extract of black seed and Urtica dioica with tamsulosin on pain improvement and expulsion of ureteral stones sized 5-10 millimeter in patients older than18 years old
Comparison effect of a combined extract of Nigella sativa and Urtica dioica with tamsulosin on pain improvement and passage of ureteral stones sized 5-10 millimeter in 18 years old patients
Design
In this non-blinded randomized parallel clinical trial, 80 Patients are allocated randomly with simple sequential allocation in one of the two groups (combined extract of Nigella sativa and Urtica dioica or tamsulosin) with help of a sealed envelope and will receive the intervention of that group.
Settings and conduct
Patients referring to Shahid Mofateh clinic of Yasuj suffering from ureteral stones with sizes of 5-10 millimeters allocated in one of two groups. the first group will receive Tamsulosin 0.4 mg per night and the second group will receive a combined extract of Nigella sativa(480 mg) and Urtica dioica(180 mg) capsule per day for two weeks. Two weeks and one month later, the patients will be re-examined and ultrasonography will be performed and the success of the treatment will measure according to the size of the stone. pain severity of patients will be checked and recorded by Visual analog scale (VAS) during treatment and two weeks after that.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age more than18 years old suffering from ureteral stone sized 5-10 millimeter
Exclusion criteria: Uncontrolled coagulopathy, Pregnancy, Azotemia, Allergy to medical or herbal drugs
Intervention groups
Intervention group: combined extract of Nigella sativa and Urtica dioica(produced by Salamat Zagros Company) will be provided in form of a capsule and will prescribe with a dosage of 600 milligrams per day after meal with one glass of water for two weeks.
Control group: Tamsulosin capsule 0.4 mg (produced by Abidi Company) 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:IRCT20081011001323N27
Registration date:2021-06-19, 1400/03/29
Registration timing:registered_while_recruiting
Last update:2021-06-19, 1400/03/29
Update count:0
Registration date
2021-06-19, 1400/03/29
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
2021-06-01, 1400/03/11
Expected recruitment end date
2022-06-01, 1401/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of a combined extract of black seed and Urtica dioica with tamsulosin on pain improvement and expulsion of ureteral stones sized 5-10 millimeter in patients older than18 years old
Public title
Comparison effect of black seed and Urtica dioica with tamsulosin in the treatment of ureteral stones
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than18 years old
Suffering from 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
Suffering from cardiovascular or pulmonary disease
Suffering from hepatic disease
Suffering from peptic ulcer 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 randomly with a simple random allocation method by use of a random number table to one of each group (combined Black seed and Urtica dioica or tamsulosin) 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
7591741414
Approval date
2021-05-19, 1400/02/29
Ethics committee reference number
IR.YUMS.REC.1400.028
Health conditions studied
1
Description of health condition studied
ureteral stones
ICD-10 code
N20.1
ICD-10 code description
Calculus of ureter
Primary outcomes
1
Description
passage of ureteral stones with sizes from 5 to 10 millimeters
Timepoint
Two weeks and one month after start of treatment
Method of measurement
Perform KUB and sonography and patient report
Secondary outcomes
1
Description
The severity of pain due to stone passage
Timepoint
During the study , two weeks and one month after starting treatment
Method of measurement
With Visual Analogue Scale (VAS)
Intervention groups
1
Description
Intervention group: combined extract of Black seed and leaf of Urtica dioica (120 mg of Urtica dioica and 120 mg of Black seed) is produced in form of a capsule and is consumed (divided into two doses) after the meal with a glass of water for 2 weeks. Also, it is recommended that patients walk and do exercise at least 30 minutes per day.
Category
Treatment - Drugs
2
Description
Control group: Tamsulosin capsule 0.4 mg day is prescribed with a glass of water every night for two weeks.Also it is recommended that patients walk and do exercise at least 30 minutes per day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mofateh clinic of Yasuj
Full name of responsible person
Sadrolleh Mehrabi
Street address
Shahid Mofateh clinic, Montazeri Street, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3322 8212
Email
sadrollahm@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Ali Mousavizadeh
Street address
Deputy of research, Yasuj University of Medical Sciences,, Motahari St
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6074
Email
health.epid@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Sadrolleh Mehrabi
Position
Professor, Director of Urology Departement, Yasuj University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Shahid Mofateh clinic, Montazeri Street, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3322 4721
Email
sadrollahm@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Sadrollah Mehrabi
Position
Professor, Chairman of Urology Department, Yasuj University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Shahid Mofateh clinic, Montazeri Street, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3322 4721
Email
sadrollahm@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Sadrollah Mehrabi
Position
Professor, Fellowship of endourology and laparoscopy
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Yasuj University of Medical Sciences, Mottahari Street, Yasuj, Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6070
Email
dr.mehrabi@yums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD