Protocol summary

Summary
This study will investigate the effect of ginger extract on gastric residual volume (GRV) in patients with mechanical ventilation hospitalized in intensive care units. A total of twenty six patients, aged 18-60 years old, who are admitted in ICU due to any medical or surgical problem, will be randomly assigned into intervention or control group. All of the patients will be gavaged with standard food for six days. The patients in the intervention group will receive 3 ml ginger extract plus 40ml water through NGT twice a day from the third day. The patients in the control group will only receive 43 ml water as placebo. Gastric residual volume GRV will be measured daily for six days and compared between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201009094722N2
Registration date: 2011-04-26, 1390/02/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-04-26, 1390/02/06
Registrant information
Name
Mitra Hekmatafshar
Name of organization / entity
MScs of Nursing
Country
Iran (Islamic Republic of)
Phone
+98 17 1443 0360
Email address
hekmatafshar@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research and Technology Deputy, Golestan University Of Medical Sciences
Expected recruitment start date
2011-02-20, 1389/12/01
Expected recruitment end date
2011-07-23, 1390/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Ginger extract on gastric residual volume in patients with mechanical ventilation hospitalized in intensive care unit
Public title
The effect of Ginger extract on gastric residual volume in patients with mechanical ventilation hospitalized in intensive care unit
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: mechanical ventilation for less than 48 hrs, patients with nasogastric tube feeding (NGT), age 18-60 years old, presence of medical or surgical problems hospitalized in intensive care unit Exclusion criteria: Presence of gallstone disease, pregnancy, breast feeding, active bleeding, lesion in gastrointestinal tract, malignancy, hypoglycemia, hyperglycemia, consumption of any medication affecting gastrointestinal motility during two weeks prior to the study or during research period
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 26
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Golestan University Of Medical Sciences, Gorgan, Iran
Street address
Golestan University of medical Sciences, Bouyeh School of Nursing & midwifery, Shastkola Road, Gorgan
City
Gorgan
Postal code
Approval date
2011-01-30, 1389/11/10
Ethics committee reference number
2907/35/پ/گ

Health conditions studied

1

Description of health condition studied
Ischaemic heart diseases
ICD-10 code
I23. I25
ICD-10 code description
Chronic ischaemic heart disease, Chronic ischaemic heart disease,

2

Description of health condition studied
Cerebrovascular diseases
ICD-10 code
I63, I65,
ICD-10 code description
Cerebral infarction, Occlusion and stenosis of precerebral arteries, not resulting in cerebral infarction , Other cerebrovascular diseases

3

Description of health condition studied
Chronic lower respiratory diseases
ICD-10 code
J40, J41,
ICD-10 code description
Chronic lower respiratory diseases

4

Description of health condition studied
Hypertensive diseases
ICD-10 code
I10, I11,
ICD-10 code description
Essential (primary) hypertension , Hypertensive heart disease ,Secondary hypertension

5

Description of health condition studied
Diseases of the nervous system
ICD-10 code
G35
ICD-10 code description
Demyelinating diseases of the central nervous system

6

Description of health condition studied
Diseases of the circulatory system
ICD-10 code
163, 166
ICD-10 code description
Cerebral infarction

Primary outcomes

1

Description
gastric residual volume
Timepoint
Every 3 hrs exactly before doing gavage
Method of measurement
by using 50cc gavage syringe

Secondary outcomes

1

Description
The amount of energy received
Timepoint
Every 24 hours
Method of measurement
the amount of received gavage food (ml) is converted to calorie

Intervention groups

1

Description
Intervention group: 3ml ginger extract plus 40ml water through NGT, twice a day, will be added to the special food for the feeding via NG tube.
Category
Treatment - Drugs

2

Description
Control group: 43 ml water, twice a day, as placebo, will be added to the special food for the feeding via NG tube.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Panj-Azar Teaching Hospital
Full name of responsible person
Mitra Hekmatafshar
Street address
Golestan University of medical Sciences, Bouyeh School of Nursing & midwifery, Shastkola Road, Gorgan
City
Gorgan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Golestan University Of Medical Sciences, Gorgan, Iran
Full name of responsible person
Dr Mohsen Aarabi
Street address
Golestan University of Medical Sciences, Bouyeh School of Nursing and midwifery, Shastkola Road, Gorgan
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Golestan University Of Medical Sciences, Gorgan, Iran
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
Golestan University Of Medical Sciences, Gorgan, Iran
Full name of responsible person
Mitra Hekmatafshar
Position
M.Sc Student of Critical Care Nursing
Other areas of specialty/work
Street address
Golestan University of Medical Sciences, Bouyeh School of Nursing and midwifery, Shastkola Road, Gorgan
City
Gorgan
Postal code
Phone
+98 17 1443 0360
Fax
Email
hekmatafshar@goums.ac.irm.hekmatafshar@yahoo.comm.hekmatafshar@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Golestan University Of Medical Sciences, Gorgan, Iran
Full name of responsible person
Leila Mahasti Jouybari
Position
Faculty Member
Other areas of specialty/work
Street address
Golestan University of Medical Sciences, Bouyeh School of Nursing and midwifery, Shastkola Road, Gorgan
City
Gorgan
Postal code
Phone
+98 17 1443 0360
Fax
+98 17 1442 5171
Email
jouybari@gmail.com
Web page address
http://jouybari.blogfa.com

Person responsible for updating data

Contact
Name of organization / entity
Golestan University Of Medical Sciences, Gorgan, Iran
Full name of responsible person
Mitra Hekmatafshar
Position
M.Sc Student of Critical Care Nursing
Other areas of specialty/work
Street address
Golestan University of Medical Sciences, Bouyeh School of Nursing and midwifery, Shastkola Road, Gorgan
City
Gorgan
Postal code
Phone
+98 17 1443 0360
Fax
Email
hekmatafshar@goums.ac.irm.hekmatafshar@yahoo.comm.hekmatafshar@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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