The purpose of this study was to determine in vitro Effects of Hydroalcholic Extract of Peganum on the contraction of the human ureter.This study is a clinical trial of phase 3, single-centered.30 ureter removed from patients undergoing nephrectomy with inclusion criteria:removed ureter samples from total nephrectomy. Exclusion criteria: Uterine tissue involved with cancer cells; Tissue infection; abnormal dilatation of the urethra are divided Five groups of six. The control group receive normal saline, The second group receive a hydroalcoholic extract of peganum harmala 1 mg per ml, The third group receive a hydroalcoholic extract of peganum harmala 2 mg per ml,Fourth group receive hydroalcoholic extract of peganum harmala 4 mg per ml and a and fifth group receive pravastatinvery low dosage. The ureter tissue was removed by nephrectomy with any reason and was placed in a UW solution at 0 ° C and immediately transferred to the lab. The ureter was separated from the size of one to two centimeters and placed in a bath of oxygen containing argon solution with temperature (37 ° C and pH = 4.7) and placed vertically between two hooks of stainless steel. The upper hook was connected to a isometric transducer by a thread and then connected to the physiograph. A weight weighing 1 gram on the opposite side of the transducer lever hangs to the tissue to make a primitive stretch. Then, by adding potassium chloride the tissue was contracted and after reaching the tissue to maximum contraction to examine the mechanism of the effect of extract, tissue With peganum harmala, Normal Saline and Prazosin extracts, the percentage of contraction force changes on paper was recorded and calculated.contraction of ureter determine the response to treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017102210222N17
Registration date:2017-10-31, 1396/08/09
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-10-31, 1396/08/09
Registrant information
Name
Zahra Keivani
Name of organization / entity
Shahrekord University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1222 0016
Email address
keivani@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
In vitro Effects of Hydroalcholic Extract of Peganum on the contraction of the human ureter undergoing nephrectomy in vitro
Public title
In vitro Effects of Hydroalcholic Extract of Peganum on the contraction of the human ureter :
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: removed ureter samples from total nephrectomy.
Exclusion criteria: Uterine tissue involved with cancer cells; Tissue infection; abnormal dilatation of the urethra
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Kashani street, shahrekord university of medical sciences, shahrekord
City
Shahrekord
Postal code
Approval date
2017-01-15, 1395/10/26
Ethics committee reference number
IR.SKUMS.REC.1395.233
Health conditions studied
1
Description of health condition studied
contraction of the human ureter
ICD-10 code
N13.7
ICD-10 code description
Vesicoureteral-reflux-associated uropathy
Primary outcomes
1
Description
Contraction of ureter
Timepoint
During intervention
Method of measurement
Checklist
Secondary outcomes
empty
Intervention groups
1
Description
The control group receive normal saline.
Category
Treatment - Drugs
2
Description
The second group receive a hydroalcoholic extract of peganum harmala 1 mg / ml.
Category
Treatment - Drugs
3
Description
The third group receive a hydroalcoholic extract of peganum harmala 2 mg / ml.
Category
Treatment - Drugs
4
Description
Fourth group: receive hydroalcoholic extract of peganum harmala 4 mg / ml and .
Category
Treatment - Drugs
5
Description
Fifth group: receive pravastatinvery by low dosage
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital in Shahrekord
Full name of responsible person
Majid Shirani
Street address
Parastar street, Kashani Hospital of Shahrekord University of Medical Sciences, shahrekord
City
shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Shahrekord University of Medical Science
Full name of responsible person
Dr. Kamal Solati
Street address
Kashani street, shahrekord university of medical sciences, shahrekord
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Shahrekord University of Medical Science
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
Shahrekord University of Medical Sciences
Full name of responsible person
Majid Shirani
Position
Urology surgeon,Associate professor
Other areas of specialty/work
Street address
Parastar street, Kashani Hospital of Shahrekord University of Medical Sciences, shahrekord
City
Shahrekord
Postal code
Phone
00
Fax
Email
Majd_uro@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Majid Shirani
Position
Urology surgeon,Associate professor
Other areas of specialty/work
Street address
Parastar street, Kashani Hospital of Shahrekord University of Medical Sciences, shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3333 5652
Fax
Email
Majd_uro@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical
Full name of responsible person
Majid Shirani
Position
Urology surgeon,Associate professor
Other areas of specialty/work
Street address
Parastar street, Kashani Hospital of Shahrekord University of Medical Sciences, shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3333 5652
Fax
Email
Majd_uro@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)