Determine the effect of Aloe vera capsule on gastrointestinal disorders in patients undergoing mechanical ventilation
Design
A triple-blind, randomized clinical trial with control group with a sample size of 36 patients.
Settings and conduct
Sampling is performed among patients with mechanical ventilation who are in the ICU section at Sabzevar Hospital. In this study, Participants (because of low level of consciousness), care provider nurse and data analyzer will be blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients undergoing mechanical ventilation, being at the age of 15 years old and over. Non inclusion criteria: digestive disorders; low blood pressure; active bleeding
Intervention groups
Patients in the intervention group receive one Aloe Vera capsule produced by Iran-Kashan Baraj Essen Company, before gavage at 9 a.m for 5 days. The control group don't receive any intervention.
Main outcome variables
Constipation; ileus; remaining food; abdominal distention; vomiting; the numbers of intestinal sounds; bloody vomiting; bloody lavage; bloody stool
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180723040565N1
Registration date:2018-10-12, 1397/07/20
Registration timing:registered_while_recruiting
Last update:2018-10-12, 1397/07/20
Update count:0
Registration date
2018-10-12, 1397/07/20
Registrant information
Name
Ezat Javanshir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3634 6057
Email address
ezat_javanshir@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-06, 1397/06/15
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Aloe Vera capsule supplementation on prevention of gastrointestinal disorders in mechanically ventilated patients.
Public title
The effect of Aloe Vera capsule supplementation on prevention of gastrointestinal disorders
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Undergoing mechanical ventilation in ICU
Feeding the patient through the gastric tube
Being at the age of 15 years or more
Air Conditioning Mode SIMV
Having informed consent of patient protector, regarding the patients participation in the research.
Air Conditioning Mode SIMV
Having informed consent of patient's protector, regarding the patient's participation in the research.
Exclusion criteria:
Having any surgery in the digestive system.
Having a history of stomach ulcers or duodenal ulcers.
Having active bleeding.
Having food allergy or allergy to Aloe vera
Being Pregnant.
Undergoing chemotherapy.
Being addict
Diagnosis of the doctor to change the type and dosage of the patient's laxative
Diagnosis of the doctor to change the patient's ventilation mode
Diagnosis of the physician based on changing the dose and type of sedation and salivation drugs
Hypothyroidism
Age
From 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Permutation blocks will be used for randomization.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants (because of low level of consciousness), care provider nurse and data analyzer will be blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sabzevar University of Medical Sciences
Street address
Block B,Campus of Sabzevar University of Medical Sciences, road of Toohid city, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
94617-85493
Approval date
2018-08-21, 1397/05/30
Ethics committee reference number
IR.MEDSAB.REC.1397.025
Health conditions studied
1
Description of health condition studied
Patients under mechanical ventilation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Percentage of people with constipation
Timepoint
Everyday (9 a.m, 3 p.m, 9 p.m) for 5 days
Method of measurement
stethoscope
2
Description
Percentage of people with vomiting
Timepoint
Everyday (9 a.m, 3 p.m, 9 p.m) for 5 days
Method of measurement
Counting the number of gas
3
Description
Percentage of people with diarrhea
Timepoint
Everyday (9 a.m, 3 p.m, 9 p.m) for 5 days
Method of measurement
Number of pads consumed
4
Description
The percentage of people with a residual stomach volume of more than 150 cc
Timepoint
Everyday (9 a.m, 3 p.m, 9 p.m) for 5 days
Method of measurement
50cc syringe
5
Description
Percentage of people with bloating
Timepoint
Everyday (9 a.m, 3 p.m, 9 p.m) for 5 days
Method of measurement
Strip meter
6
Description
Percentage of people with ileus
Timepoint
Everyday(9 a.m, 3 p.m, 9 p.m) for 5 days
Method of measurement
stethoscope
7
Description
Percentage of people with reduced intestinal sounds
Timepoint
Everyday (9 a.m, 3 p.m, 9 p.m) for 5 days
Method of measurement
stethoscope
8
Description
Percentage of people with hematochezia
Timepoint
Before intervention and after intervention
Method of measurement
Complete blood count (CBC) test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: They receive one Aloe Vera capsule produced by Iran-Kashan Baraj Essen Company, before gavage at 9 a.m for 5 days.
Category
Prevention
2
Description
Control group: This group does not receive intervention
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Sabzevar University of Medical Sciences
Full name of responsible person
Mostafa Rad
Street address
Block B, Campus University of Medical Sciences , Tohid Shahr Road, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873119
Phone
+98 51 4401 1000
Fax
+98 51 4401 1013
Email
info@medsab.ac.ir
Web page address
http://www.medsab.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fereshteh Ghorat
Street address
Block B,Campus of Sabzevar University of Medical Sciences, road of Toohid city, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873119
Phone
+98 51 4401 1000
Fax
+98 51 4401 1013
Email
info@medsab.ac.ir
Web page address
http://www.medsab.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Mostafa Rad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Block B,Campus of Sabzevar University of Medical Sciences, road of Toohid city, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873119
Phone
+98 51 4401 8314
Email
mostafarad633@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mostafa Rad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Block B,Campus of Sabzevar University of Medical Sciences, road of Toohid city, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873119
Phone
+98 44018314
Email
mostafarad633@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mostafa Rad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Block B,Campus of Sabzevar University of Medical Sciences, road of Toohid city, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873119
Phone
+98 51 4401 8314
Email
mostafarad633@yahoo.com
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
No more information
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