The aim of the study: the effect of the extract of nettle on short-term outcomes ureteral double J catheter.
The design of the study: randomized, double-blind, placebo controlled, single-center, phase 1-2 trial.
The study population: all patients 20 to 70 years old following the lithotripsy for ureteral double J catheter is embedded.
The main criteria for inclusion: stone size (lesser than ten mm) and place the stone below the junction (ureteral pelvic).
Exclusion criteria: previous surgery on the bladder or lower urinary tract; active urinary tract infection; lack of proper placement of the double J catheter.
Sample size: 62.
Case study: urtidin pills (nettle extract) essential pharmaceutical company Barij a dosage of one pill every 8 hours for fifteen days.
Intervention time: urtidin pills with a dosage of one tablet every 8 hours for a period of fifteen days it will be given to the intervention group.
The outcome of the study: 1. Dysuria; 2- frequency;
3. hematuria, with starting at least 24 hours after surgery; 4. pain in the flank area; 5. Urinary Tract Infection; 6. Fever; 7. mucosal inflammation of the bladder and ureter.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016090329680N1
Registration date:2017-03-18, 1395/12/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-18, 1395/12/28
Registrant information
Name
Saeed Heydari
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
s.heydari91@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahroud University of Medical Sciences
Expected recruitment start date
2017-03-10, 1395/12/20
Expected recruitment end date
2017-07-11, 1396/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Urtica dioica extract on short-time consequences of double-J ureteral catheters
Public title
The effect of Urtica dioica exstract on consequences of double-J ureteral catheters
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: the size of the stone and the location of the stone which measures (less than ten mm) and place the stone below the junction (urethral pelvic); patients suffering a urethral stone, just on one side and those who bilateral urethral stones or kidney stones are excluded; age between 20-70 years old(due to a higher incidence of kidney stones in this age range); no history of urologic manipulation in the past few years is a another criteria.
Exclusion criteria: history of benign prostatic hypertrophy; previous surgery on the bladder or lower urinary tract; bladder stones; active urinary tract infection; lack of proper placement of the double J catheter; neurogenic bladder and the lack of the next visit.
Age
From 20 years old to 70 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Sharoud University of Medical Sciences
Street address
Sharoud University of Medical Sciences, 7th Tir square
City
Shahroud
Postal code
3613773955
Approval date
2015-12-22, 1394/10/01
Ethics committee reference number
IR.SHMU.REC.1394.145
Health conditions studied
1
Description of health condition studied
Complications of double j urethral cathater
ICD-10 code
T83
ICD-10 code description
Complications of genitourinary prosthetic devices, implants and grafts
Primary outcomes
1
Description
gross hematuria
Timepoint
3 and 7 days after start of treatment
Method of measurement
questionnaire
2
Description
dysuria
Timepoint
3, 7 and 15 days after start of treatment
Method of measurement
questionnaire
3
Description
frequency
Timepoint
3, 7 and 15 days after start of treatment
Method of measurement
questionnaire
4
Description
pain
Timepoint
3, 7 and 15 days after start of treatment
Method of measurement
VAS score
5
Description
microscopic hematuria
Timepoint
15 days after start of treatment
Method of measurement
urine analysis
6
Description
edema and inflammation of the mucus of bladder and ureter
Timepoint
15 days after start of treatment
Method of measurement
cystoscopy
7
Description
urinary infection
Timepoint
15 days after start of treatment
Method of measurement
urine cuture
8
Description
fever
Timepoint
3, 7 and 15 days after start of treatment
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The control group patients after discharge - the day after surgery - and for a period of 48 hours, antibiotic cefixime 400, on a daily basis and 10 ibuprofen housing 400, one pill, given every 8 hours.
Category
Treatment - Drugs
2
Description
In the intervention group, in addition to these drugs, pills urtidin pharmaceutical barij company, a dosage of one pill every 8 hours, for a period of fifteen days it will be given.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Urology clinic or Emergency Department of Emam Hossein Hospital
Full name of responsible person
Saeed Heydari
Street address
Emam Hossein Hospital
City
Shahroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sharoud University of Medical Sciences
Full name of responsible person
Hassan Emamian
Street address
Sharoud University of Medical Sciences, 7th Tir square
City
Shahroud
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sharoud University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Clinical Research Development, Sharoud University of Medical Sciences
Full name of responsible person
Saeed Heydari
Position
Medical student
Other areas of specialty/work
Street address
Sharoud University of Medical Sciences, 7th Tir square
City
Shahroud
Postal code
Phone
+98 23 3239 5054
Fax
Email
s.heydari91@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sharoud University of Medical Sciences
Full name of responsible person
Naser Mogharabian
Position
Urologist
Other areas of specialty/work
Street address
Sharoud University of Medical Sciences, 7th Tir square
City
Shahroud
Postal code
Phone
+98 23 3239 5054
Fax
Email
Dr.mogharabian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Clinical Research Developement, Sharoud University of Medical Sciences, 7th Tir square ity of medica
Full name of responsible person
Saeed Heydari
Position
Medical student
Other areas of specialty/work
Street address
Sharoud University of Medical Sciences, 7th Tir square
City
Shahroud
Postal code
Phone
+98 23 3239 5054
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)