investigation of acute ibuprofen ingestion on acute kidney damage
Design
Twenty dysmenorrhea patients will divided into two groups. In group one, ten patients will receive 400 mg ibuprofen capsules every 8 hours for one day. Group two will receive placebo capsules with the same protocol. Blood samples will be withdrawn before intervention and 12 hours after intervention.
Settings and conduct
Dysmenorrhea volunteers will be recruited in Qom city. They are blind about the intervention. Blinding and package coding will be conducted by the investigator.
Participants/Inclusion and exclusion criteria
20 dysmenorrhea with healthy kidneies
Intervention groups
Two groups; Group one will receive ibuprofen and Group two will receive placebo
Effects of short term ibuprofen on NGAL level in dysmennorrhea, a pilot study
Public title
Effects of short term ibuprofen on noutrophil NGAL level in dysmennorrhea, a pilot study
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Dysmenorrhea
Exclusion criteria:
History of renal dysfunction
Age
From 13 years old to 55 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
Before and after menstruation blood samples withdrawn
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients will receive packages containing three capsules. Patients are not aware of the content. Capsules was packaged and coded by the investigator.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Azad Tehran University of Medical Sciences
Street address
Ghods Town (West), between South Flamek and Zarafshan, Iran TV Street - Headquarters of the Ministry of Health, Treatment and Medical Education, Block A, 13th floor
City
Tehran
Province
Tehran
Postal code
ethics.research.ac.i
Approval date
2020-01-11, 1398/10/21
Ethics committee reference number
IR.IAU.PS.REC.1398.294
Health conditions studied
1
Description of health condition studied
Primary dysmennorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhea
Primary outcomes
1
Description
NGAL biomarker level
Timepoint
Before and 12h after consumption of 1200 mg of ibuprofen
Method of measurement
NGAL ELISA kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group 1 including 10 randomly assigned patients. They will recieve 400mg ibuprofen capsules every 8 hours for 24 hours. Before intervention and 12 hours after intervention blood samples will be withdrawn.
Category
Treatment - Drugs
2
Description
Control group: Intervention group: Group 2 including 10 randomly assigned patients. They will recieve placebo capsules every 8 hours for 24 hours. Before intervention and 12 hours after intervention blood samples will be withdrawn.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Danesh laboratory
Full name of responsible person
Kowsar Marefat
Street address
1th Floor, No. 19, 10th Alley, 19 Dey Ave
City
Qom
Province
Ghoum
Postal code
3713615759
Phone
+98 25 3771 4869
Email
qdaneshlab@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farshad Hashemian
Street address
District 1, Yakhchal Street، Yasaman Alley
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0051
Email
fhashemian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
azad islamic university
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
Islamic Azad University
Full name of responsible person
Ramin Abrishami
Position
Assoiate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
District 1, Yakhchal Street، Yasaman Alley
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
009822640051
Email
r_abrishami@iaups.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ramin Abrishami
Position
Associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
District 1, Yakhchal Street، Yasaman Alley
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0051
Email
r_abrishami@iaups.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ramin Abrishami
Position
Associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
District 1, Yakhchal Street، Yasaman Alley
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0051
Email
r_abrishami@iaups.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available