This is a single-blind, randomized clinical trial study with purpose of comparing the effects of erythromycin with ginger extract on gastric residual volume in patients of intensive care unit .Inclusion criteria included: age 18 to 75 years, feeding through a nasogastric or orogastric tube and patients under mechanical ventilation and exclusion criteria included: sensitivity to the ginger or erythromycin, taking corticosteroids, active bleeding or patients at risk of bleeding. The research population consisted of patients under mechanical ventilation in the intensive care unit. The sample size is 90 patients who will randomly allocate with using a block in the control group (erythromycin) and intervention group (Ginger). The gastric residual volume will be measured before each time feeding and if gastric residual volume was more than 200 cc after an hour re-examined, Patients in the control and intervention groups will take place; Erythromycin syrup to patients in the control group and ginger extract to patient in the intervention group will be given 4 doses per day. Gastric residual volume will be recorded and after reaching the gastric residual volume to less than 200 cc can increase the volume of the patient's diet. These Medications up to full feeding continue, and then will stop.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201505257494N13
Registration date:2015-07-31, 1394/05/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-31, 1394/05/09
Registrant information
Name
Masoumeh Bagheri Nesami
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7551
Email address
mbagheri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mazandaran University of Medical Science
Expected recruitment start date
2015-06-10, 1394/03/20
Expected recruitment end date
2015-09-11, 1394/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparative effects of erythromycin and ginger extract on gastric residual volume in hospitalized patients in intensive care unit.
Public title
Ginger effect on gastric emptying rate of ICU patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 18 to 75 years ; fed through stomach catheter ; a medical illness and neurological (the study of internal intensive care unit) ; mechanically ventilated patients ; over 24 hours of admission to the ICU (the according to the standards of feeding patients should be started within 48 to 24 hours after admission to the ICU).
Exclusion criteria: any food allergies recorded in the patient's case history sheet of reactions to medication during the study ; a history of drug use increase of bowel movements ; pregnancy ; lactation ; particularly corticosteroids and taking any immunosuppressive medicine ; cancer ; disease and gastrointestinal ulcers ; active bleeding or patients at risk of bleeding because of (the effects of ginger in the Inhibition of the synthesis of thromboxane) ; history of gallstones (due to the effects of ginger on Stone building) ; the Occurrence of intestinal paralysis ; use of laxatives.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Science
Street address
Moalem Street, Moalem Square, Sari
City
Sari
Postal code
4817844718
Approval date
2015-07-05, 1394/04/14
Ethics committee reference number
IR.MAZUMS.REC.94
Health conditions studied
1
Description of health condition studied
gastric residual volume
ICD-10 code
K31.9
ICD-10 code description
Disease of stomach and duodenum, unspecified
Primary outcomes
1
Description
Gastric residual volume
Timepoint
Before each feeding through gastric tube
Method of measurement
With using a 60 cc gavage syringe
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: Ginger extract (aroomin- Jasmine drug, Iran) 2 g (every 120 drops of the drug equivalent to 1 gram), 4 times a day until the gastric residual volume reach to less than 200 ml.
Category
Treatment - Drugs
2
Description
Control: erythromycin syrup (Tehran chemistry, Iran) 200 mg per 5 mL, 2.5 mg / kg, 4 times a day until the gastric residual volume reach to less than 200 ml.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Ruohani Hospital
Full name of responsible person
Seyede Zahra Mirshabani
Street address
Farmer Street, Worker squer, Babol
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Ahmad Ali Enayati
Street address
Iran - Mazandaran - sari - University of Medical Sciences
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
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
School of Nursing & Midwifery Mazandaran University of Medical, Sciences, Sari, Iran.
Full name of responsible person
Seyede Zahra Mirshabani
Position
BS / MS student of Critical Care Nursing
Other areas of specialty/work
Street address
No.164, Sahar street, Farhang shahr, Babol
City
Babol
Postal code
Phone
+98 11 3225 1243
Fax
Email
mirshabani.zahra@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Science
Full name of responsible person
Dr Masumeh Bagheri Nesami
Position
Associate professor
Other areas of specialty/work
Street address
School of Nursing & Midwifery Mazandaran University of Medical, Sciences, Sari, Iran.
City
Sari
Postal code
4815696869
Phone
+98 113336345
Fax
Email
anna3043@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)