1. Home
  2. Approved trials
  3. » فارسی

Comparing the effect of dried plums (prunes) with magnesium hydroxide on the constipation management of cerebrovascular accident patients hospitalized in intensive care unit.

Protocol summary

Summary
ا) Aims: Comparison of the Effect of Dried plums and Magnesium Hydroxide on Constipation in Patients with Stroke Admitted to the Intensive Care Unit 2) Design: A total of 30 patients with stroke admitted to intensive care unit with constipation and nasogastric tube are randomly divided into two groups. The intervention group receives Dried plums . And the control group was magnesium hydroxide. 3) How to do.Through the stomach catheter 4)inclusion criteria: patients over 18 years of age, stroke , having a stomach catheter, constipation, not having diabetes,not having allergy to plum not having thyroid disease and neuromuscular diseases.Exclusion criteria: natural stool, diarrhea, patient death, discharge. 5)intervention; : The researcher put 50 grams of plum for 24 hours at 170 cc of water , Then, it is softened and bypassing the filter and in the form of syrup (200 cc volume) from the third day onwards if there is constipation, for two days, twice a day at 8 and 20 o'clock the patient is gavaged. In the second group, which is the control group, 30 cc of magnesium hydroxide with 170 cc of water is bubbled twice a day at 8 and 20 o'clock the patient is gavaged. 6) Main outcome variables: Primary outcome: Frequency stool and Secondary outcome: Fecal Consistency of Patients

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201709107494N26
Registration date: 2017-11-07, 1396/08/16
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-11-07, 1396/08/16
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 Sciences
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-04-20, 1397/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of dried plums (prunes) with magnesium hydroxide on the constipation management of cerebrovascular accident patients hospitalized in intensive care unit.
Public title
effect of dried plums on the constipation of cerebrovascular accident patients
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria; includes all patients over 18 years of age who are admitted to the specialty because of stroke and have nasal catheter and constipated. It also includes no diabetes, no history of surgery, diseases and gastrointestinal tract ulcers, no history of chronic constipation, no use of effective drugs on intestinal movements, no history of plague allergy, no history of thyroid disease and neuromuscular diseases. Exclusion criteria: natural stool, diarrhea, patient death, discharge.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 30
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
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Vice chancellor for research, Moalem street, Moalem square, Sari, Mazandaran, Iran
City
sari
Postal code
4816715793
Approval date
2017-09-21, 1396/06/30
Ethics committee reference number
IR.MAZUMS.REC.96-10283

Health conditions studied

1

Description of health condition studied
Constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation

Primary outcomes

1

Description
Frequent bowel movements
Timepoint
1 day before intervention and day(s) after of intervention
Method of measurement
number

Secondary outcomes

1

Description
consolidation stool
Timepoint
1 day before intervention and day(s) after of intervention
Method of measurement
bristol scale

Intervention groups

1

Description
Intervention group: Fifty grams of dried plums are soaked in 170 cc of water for 24 hours and the nucleus is removed. Then, with a blender, make it soft and pass through the filter and in the form of a syrup (volume 200 cc) from the third day onwards if constipation or stool is present for two days, twice a day at eight o'clock in the morning And eight nights will be given.
Category
Treatment - Other

2

Description
Control group: 30 cc magnesium hydroxide of Alborz Company with a registration number (1228033896) with 170 cc of water from the third day after being admitted in case of constipation or stool for two days, twice a day at eight o'clock in the morning and eight Night will be given.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
boali sina hospital
Full name of responsible person
Dr Masoumeh Bagheri- Nesami
Street address
boali sina hospital
City
sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research Mazandaran University of Medical Sciences, Moalem Street, Moale
Full name of responsible person
Dr Ahmad Ali Enayeti
Street address
Vice Chancellor for research Mazandaran University of Medical Sciences, Moalem Street, Moalem Square, Sari, Iran
City
sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research Mazandaran University of Medical Sciences, Moalem Street, Moale
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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Masumeh Bagheri Nesami
Position
PHD/ faculty member
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, three-way Joibar, highway Basij, Imam square, Sari, Mazandaran
City
sari
Postal code
Phone
+98 113336755
Fax
Email
anna3043@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Masumeh Bagheri Nesami
Position
PHD/ faculty member
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, three-way Joibar, highway Basij, Imam square, Sari, Mazandaran
City
sari
Postal code
Phone
+1 133367551
Fax
Email
anna3043@gmail.com
Web page address

Person responsible for updating data

Contact

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
Loading...