This study will investigate the effect of fenugreek seeds on gastrointestina disorder in patients with mechanical ventilation hospitalized in intensive care units. A total of sixty patients; ged 15-80 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 five days.The patients in the control group will receive food is just as routine. Gastric residual volume GRV; the incidence of regurgitation; diarrhea; constipation; abdominal sounds; and ileus; gastrointestinal bleeding; bloating and abdominal distension and daily measurement. will be measured daily for five days and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016021126511N1
Registration date:2016-05-06, 1395/02/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-06, 1395/02/17
Registrant information
Name
Azam Zarghi
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4466 0944
Email address
zarghia92@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Sabzevar University of Medical Sciences
Expected recruitment start date
2015-10-22, 1394/07/30
Expected recruitment end date
2016-04-19, 1395/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of fenugreek seeds on some gastrointestinal disorder in patients with mechanical ventilation
Public title
The effect of fenugreek seeds on some gastrointestinal disorder in patients with mechanical ventilation.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients with informed consent to participate in research; mechanical ventilation; nasogastric tube feeding (NGT); age15-80 years old; hemodynamic stability; Absence of pancreatitis, severe renal failure; severe hypothyroidism; hyperparathyroidism diseases and pregnancy; Non is history partial or total gastrostomy and Food allergies.
Exclusion criteria: Parents patient's or patient's refusal to continue participate in research; Patients who do not tolerate gavage; INR>2; patient died during the study.
Age
From 15 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Sabzevar University of Medical Sciences
Street address
Building number two, Vice Chancellor for Education, University of Sabzevar
City
Sabzevar
Postal code
2264462
Approval date
2015-12-28, 1394/10/07
Ethics committee reference number
IR.MEDSAB.REC.1394.128
Health conditions studied
1
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
Based on the registration number of daily excretion in patient chart
3
Description
Abdominal bloating and distension
Timepoint
Every 24 hours
Method of measurement
Measuring Abdominal circumference to Using a tape measure in centimeter and touching stiffness abdominal to hands and auscultation sounds with stethoscope
4
Description
regurgitation
Timepoint
Every 24 hours
Method of measurement
Based on the regurgitation number of daily excretion in patient chart
5
Description
abdominal sounds
Timepoint
Every 24 hours
Method of measurement
Listen to the sounds of each of the four quadrants of the abdomen with a stethoscope in 5 minutes once a day
6
Description
gastrointestinal bleeding
Timepoint
Every 24 hours
Method of measurement
Sighting vomiting blood, disposal of light bleeding and similar to coffee grounds from the nasogastric tube , black and tarry stools , loss of hemoglobin 2 g over 48 hours without bloodshed another, guaiac test is positive. ( check hemoglobin routinely performed and recorded in the sector)
Secondary outcomes
empty
Intervention groups
1
Description
in the intervention group will receive 3mg fenugreek seeds through NGT, twice a day, will be added to the special food for the feeding via NG tube for five days.
Category
Treatment - Drugs
2
Description
in The control group was routinely given special food only / no action
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emdad Hospital,Sabzevar
Full name of responsible person
Azam Zarghi
Street address
Sabzevar University of Medical Sciences
City
Sabzevar
2
Recruitment center
Name of recruitment center
Waseii Hospital, Sabzevar
Full name of responsible person
Azam Zarghi
Street address
Sabzevar University of Medical Sciences
City
Sabzevar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Musa Al-Reza Taday'oun far
Street address
Building number two, Vice Chancellor for Education, Sabzevar University of Medical Sciences and Health Services
City
Sabzevar
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
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
Sabzevar University of Medical Sciences
Full name of responsible person
Zarghi Azam
Position
Student of Critical Care Nursing
Other areas of specialty/work
Street address
Building number two, Vice Chancellor for Education, University of Sabzevar