Comparison of the effect of Mint and Chamomile on residual stomach volume in patients undergoing nasogastric feeding in intensive care unit, Kowsar hospital, Semnan
The aim of this study is to compare the effect of mint and chamomile on gastric residual volume in patients who admitted in intensive care units and feed via nasogastric tube.
Design
In a clinical trial, patients were assigned to study groups using randomized six-block. The person who evaluated outcomes was not aware from the type of intervention.
Settings and conduct
The study was conducted at Kowsar Hospital affiliated with the Semnan University of Medical Sciences and Health Services.
Participants/Inclusion and exclusion criteria
The research sample is all patients undergoing feeding by nasogastric tube who be admitted to the intensive care unit for more than 24 hours and ventilated mechanically with supportive modes, will be enrolled in the study. Patients who are hospitalized for gastrointestinal surgery, patients who has food allergy and vomiting, as well as pregnant and breastfeeding women and patients with diabetes are excluded from the study.
Intervention groups
First group will receive 5 milliliter of peppermint solution via nasogastric tube after each feeding period during 24 hours in addition to the usual management. After 12 hours from the last feeding and receiving of peppermint solution, in the next 24 hours, at the end of each feeding period, 8 ml of chamomile solution is given via nasogastric tube. Second intervention group, will receive of chamomile solution via nasogastric tube after each feeding period during 24 hours. After 12 hours from the last feeding and receiving of chamomile solution, in the next 24 hours, 5 milliliter of peppermint solution is given to the patient via nasogastric tube. Before each gavage, gastric residual is measured by aspiration, if gastric residual volume is less than 50% of the intake returned to the patient.
Main outcome variables
Main outcome variable is Gastric residual volume
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151020024625N10
Registration date:2019-02-06, 1397/11/17
Registration timing:registered_while_recruiting
Last update:2019-02-06, 1397/11/17
Update count:0
Registration date
2019-02-06, 1397/11/17
Registrant information
Name
Mehrdad Zahmatkesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3343 7844
Email address
mehrdadzahmatkesh@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-10, 1397/10/20
Expected recruitment end date
2019-06-09, 1398/03/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Mint and Chamomile on residual stomach volume in patients undergoing nasogastric feeding in intensive care unit, Kowsar hospital, Semnan
Public title
Comparison of The effect of Mint and Chamomile on residual gastric volume in patients undergoing nasogastric feeding
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Admission to ICU for more than 24 hours
Feeding via nasogastric tube
Exclusion criteria:
Admission to ICU due to gastrointestinal surgery
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization by six block randomization
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patient, person who collected data and analyzed will be blinded of the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Approval date
2019-01-06, 1397/10/16
Ethics committee reference number
IR.SEMUMS.REC.1397.219
Health conditions studied
1
Description of health condition studied
Gastric residual volume
ICD-10 code
K30
ICD-10 code description
Delayed gastric emptying
Primary outcomes
1
Description
Gastric residual volume
Timepoint
Every 3 hours at the end of the nutrient solution gavage
Method of measurement
By NG tube and aspiration with syringe
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First intervention group, in addition to the usual management and interventions, will receive 5 milliliter of peppermint solution (40 drops peppermint extract in 40 ml of drinking water) through the nasogastric tube after each feeding period during 24 hours. After 12 hours from the last feeding and receiving of peppermint solution, in the next 24 hours, at the end of each feeding period, 8 ml of chamomile solution (90 drops of chamomile in 40 milliliter of drinking water) is given to the patient through the nasogastric tube. Before each feeding, the gastric residual is measured by aspiration and recorded, if gastric residual volume is less than 50% of the intake returned to the patient.
Category
Treatment - Other
2
Description
Intervention group: Second intervention group, in addition to the usual management and interventions, will receive of chamomile solution (90 drops of chamomile in 40 milliliter of drinking water) through the nasogastric tube after each feeding period during 24 hours. After 12 hours from the last feeding and receiving of chamomile solution, in the next 24 hours, at the end of each feeding period, 5 milliliter of peppermint solution (40 drops peppermint extract in 40 ml of drinking water) is given to the patient through the nasogastric tube. Before each feeding, the gastric residual is measured by aspiration and recorded, if gastric residual volume is less than 50% of the intake returned to the patient.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital, affiliated to Semnan Universities of Medical Sciences
Full name of responsible person
Samaneh Rahbar
Street address
Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2120
Email
bahar.samaneh.89@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei MD
Street address
Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3345 1336
Email
sem.ums.res@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Abassali Ebrahimian PhD
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health in Emergency and Disaster
Street address
Km 5 Dameghan Road, Nursing Faculty
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3346 5191
Email
aa.ebrahimian@semums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Abassali Ebrahimian PhD
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health in Emergency and Disaster
Street address
Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3346 5191
Email
aa.ebrahimian@semums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mehrdad Zahmatkesh
Position
Researcher
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Km 5 Dameghan Road, Nursing Faculty
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3346 5191
Email
mehrdadzahmatkesh@semums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only final repot will published.
When the data will become available and for how long
After completing of study
To whom data/document is available
Any person who request.
Under which criteria data/document could be used
Referees
From where data/document is obtainable
Contact by email
What processes are involved for a request to access data/document
Contact with responsible person and supervisor permission