Determination of the effect of PP on prevention of constipation in patients with acute myocardial infarction
Design
The study is a triangular randomized clinical trial. They were selected by objective sampling method and divided into two intervention and control groups by block method. 110 patients who under the constipation checklist score more than 1 and are exposed The risk is moderate to severe constipation
Settings and conduct
110 of those who are admitted to the ccu section of Amir almomenin and Amir kabir Shahr hospitals in Arak in 1397 and who have the characteristics of the study are studied.
A randomized, triangular clinical trials trial. Which is done in two groups. The development of this study is that the patient, the prescribing nurse and the statistician do not know the intervention and control group and the type of intervention.
Participants/Inclusion and exclusion criteria
Acute myocardial infarction,
Statement of willingness to participate in the study,
Insensitivity to herbal medicines
Blood sugar control
No chronic constipation
Lack of digestive diseases
No use of constipation drugs
Unlimited fluid intake
Being hospitalized for at least 3 days
Motionless on the bed
Earn score 1 and more based on constipation tool
Pregnancy and lactation
Intervention groups
The intervention group receives a 5-gram pre-filled flour powder prepared by a researcher, fasting for 3 days a day. The powder should be in 150-210 ml of hot water for 1-5 hours before use. Soak up. The placebo control group will receive the saccharide, such as the intervention group but breadcrumbs.
Main outcome variables
Constipation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180712040439N1
Registration date:2018-08-27, 1397/06/05
Registration timing:registered_while_recruiting
Last update:2018-08-27, 1397/06/05
Update count:0
Registration date
2018-08-27, 1397/06/05
Registrant information
Name
Zahra Asgarynezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3313 8179
Email address
z.asgarinezhad@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of plantago ovata forsk on prevention of constipation among patients with acute myocardial infarction
Public title
Effect of plantago ovata forsk on prevention of constipation among patients with acute myocardial infarction
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
patient willingness to participate in the study
no reaction to herbal productions
no chronic constipation
Exclusion criteria:
diabetic patients
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
convenience sampling and blocking method
Blinding (investigator's opinion)
Triple blinded
Blinding description
The patient is unaware of the type of herbal medicine used to prevent constipation, because both medicine and placebo are saccharified in volatile water and consumed.
On the other hand, the data collection nurse is not aware of the patient's drug use, as the researcher gave the patient with a herbal drug with the help of a nurse co-worker before data collection.
The statistician is also unaware of the two groups because the data is presented in the form of the intervention group code and the control group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Scienes
Street address
Niayesh Apartment, Behdary St, Nurse Sq
City
Arak
Province
Markazi
Postal code
3819684764
Approval date
2018-06-10, 1397/03/20
Ethics committee reference number
IR.ARAKMU.REC.1397.060
Health conditions studied
1
Description of health condition studied
Acute myocardial infarction
ICD-10 code
121
ICD-10 code description
121
Primary outcomes
1
Description
Constipation
Timepoint
For three consecutive days
Method of measurement
Constipation Assessment Scale
Secondary outcomes
1
Description
dose not have
Timepoint
dose not have
Method of measurement
dose not have
Intervention groups
1
Description
Intervention group: The intervention group after receiving the terms of participation in the study for a period of three consecutive days receive the PSF in a fasting state.
Category
Treatment - Drugs
2
Description
Control group: The group receives the placebo-based rusks for three consecutive days and fasting.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir kabir Hospital
Full name of responsible person
Zahra Asgarynezhad
Street address
Niayesh Apartment, Behdary St, Nurse Sq
City
Arak
Province
Markazi
Postal code
3819684764
Phone
+98 86 3313 8179
Email
z.asgarinezhad@arakmu.ac.ir
Web page address
2
Recruitment center
Name of recruitment center
Amir almomenin Hospital
Full name of responsible person
Zahra Asgarynezhad
Street address
Niayesh Apartment, Behdary St, Nurse Sq
City
Arak
Province
Markazi
Postal code
3819684764
Phone
+98 86 3313 8179
Email
z.asgarinezhad@arakmu.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Arjmandzadeghan
Street address
Niayesh Apartment, Behdary St, Nurse Sq
City
Arak
Province
Markazi
Postal code
3819684764
Phone
+98 86 3313 8179
Email
z.asgarinezhad@arakmu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Zahra Asgarynezhad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Niayesh Apartment, Behdary St, Nurse Sq
City
Arak
Province
Markazi
Postal code
3819684764
Phone
+98 86 3313 8179
Email
z.asgarinezhad@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Zahra Asgarynezhad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Niayesh Apartment, Behdary St, Nurse Sq
City
Arak
Province
Markazi
Postal code
3819684764
Phone
+98 86 3313 8179
Email
z.asgarinezhad@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Zahra Asgarynezhad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Niayesh Apartment, Behdary St, Nurse Sq
City
Arak
Province
Markazi
Postal code
3819684764
Phone
+98 86 3313 8179
Email
z.asgarinezhad@arakmu.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