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Comparison of Liquorice and Zataria multiflora effects on gastrointestinal symptoms in ICU and CCU nurses

Protocol summary

Summary
Background and goal: According to prevalence of gastrointestinal disorders among intensive care unit (ICU) nurses, current study focuses on a comparison between effects of Glycyrrhiza glabra and Zataria multiflora on gastrointestinal disorders to introduce an efficient, safe, and affordable method to treat these disorders. Inclusion criteria: At least 1 year record of service in intensive care unit, and affected by gastrointestinal disturbances during the last weak. Exclusion criteria: Affected by any severe systemic diseases. Moreover, volunteers receiving any medical treatment of stress induced symptoms (such as sleeping pills, antidepressants, or anxiolytics). Methodology:To do so, 105 ICU nurses are sampled according to the aforementioned inclusion and exclusion criteria , triple-blind (nursing, researcher and analyzer) and classified to three groups, including two intervention groups and one control group, randomly. Then, treatment is carried out through Glycyrrhiza glabra and Zataria multiflora in first and second intervention groups, respectively for 4 weeks while placebo is utilized for the control group. Primary outcome measures including reflux, abdominal pain, flatulence, constipation and diarrhea. Secondary outcome measure including dry mouth, vomiting, abdominal pain result by hunger. Then, existence of gastrointestinal symptoms and their intensity in nurses (based on visual analog scale (VAS) grade) are evaluated via a questionnaire before and after treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014100419330N2
Registration date: 2014-11-22, 1393/09/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-11-22, 1393/09/01
Registrant information
Name
Zaynab Vafa Arani
Name of organization / entity
Arak university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 31 5473 8565
Email address
z.vafaarany@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Science
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Liquorice and Zataria multiflora effects on gastrointestinal symptoms in ICU and CCU nurses
Public title
A comparison between effects of Glycyrrhiza glabra and Zataria multiflora on gastrointestinal disorders of ICU nurses
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: To be eligible for this trial, each volunteer needs to meet the following criteria at a screening and baseline visit: Volunteers between 20 to 55 years old, male or female, capable of giving informed consent, to have at least 1 year record of service in intensive care unit, and affected by gastrointestinal disturbances during the last weak. Exclusion criteria: Nonconformity with medication regimen, being affected by any severe systemic diseases. Moreover, volunteers that are receiving any medical treatment of stress induced symptoms (such as sleeping pills, antidepressants, or anxiolytics) or those who have taken such treatment since 3 months ago or later are also excluded. In addition, those volunteers who are using nicotine or who have weaned since 6 months ago are excluded.
Age
From 20 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
A random number between 1 and 105 is assigned to each of nurses (satisfying inclusion criteria) and then they classified to three groups via random number generation.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committe of Arak University of Medical Science
Street address
Basij square, Sardasht, Arak, Iran
City
Arak
Postal code
Approval date
2014-07-22, 1393/04/31
Ethics committee reference number
1915/1/5/29/پ

Health conditions studied

1

Description of health condition studied
Irritable bowel syndrome
ICD-10 code
k58
ICD-10 code description
Irritable bowel syndrome

2

Description of health condition studied
Constipation
ICD-10 code
k59.0
ICD-10 code description
Constipation

3

Description of health condition studied
Functional diarrhoea
ICD-10 code
k59.1
ICD-10 code description
Functional diarrhoea

4

Description of health condition studied
Fissure and fistula of anal and rectal regions
ICD-10 code
k60
ICD-10 code description
Fissure and fistula of anal and rectal regions

5

Description of health condition studied
Abscess of anal and rectal regions
ICD-10 code
k61
ICD-10 code description
Abscess of anal and rectal regions

6

Description of health condition studied
Other diseases of anus and rectum
ICD-10 code
k62
ICD-10 code description
Other diseases of anus and rectum

7

Description of health condition studied
Other diseases of intestine
ICD-10 code
k63
ICD-10 code description
Other diseases of intestine

8

Description of health condition studied
Other specified diseases of digestive system
ICD-10 code
k92.8
ICD-10 code description
Other specified diseases of digestive system

9

Description of health condition studied
Disease of digestive system, unspecified
ICD-10 code
K92.9
ICD-10 code description
Disease of digestive system, unspecified

Primary outcomes

1

Description
Abdominal pain
Timepoint
4 weeks
Method of measurement
Questionnaire

2

Description
Pyrosis
Timepoint
4 weeks
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Change in bowel habits (Constipation, Diarrhea)
Timepoint
4 Weeks
Method of measurement
Questionnaire

2

Description
Reflux
Timepoint
4 Weeks
Method of measurement
Questionnaire

3

Description
Flatulence
Timepoint
4 Weeks
Method of measurement
Questionnaire

4

Description
Xerostomia
Timepoint
4 Weeks
Method of measurement
Questionnaire

5

Description
Vomiting
Timepoint
4 Weeks
Method of measurement
Questionnaire

6

Description
Abdominal pain caused by hunger
Timepoint
4 Weeks
Method of measurement
Questionnaire

Intervention groups

1

Description
First intervention group: First intervention group treatment is carried out via Glycyrrhiza glabra (3 capsule D-reglis: 650mg per day) during 4 weeks.
Category
Treatment - Drugs

2

Description
Control group: In control group, placebo is utilized (3 capsule starches per day) during 4 weeks.
Category
Placebo

3

Description
Second intervention group: Second intervention group treatment is carried out via Zataria multiflora (3 capsule gastrolit: 20 mg per day) during 4 week.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Street address
City
Kashan

2

Recruitment center
Name of recruitment center
Imam Ali Heart Center
Full name of responsible person
Street address
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Arak University of Medical Science
Full name of responsible person
Dr. Davood Hekmatpou
Street address
Amir-al-momenin hospital, Basij square, Sardasht, Arak, Iran
City
Arak
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 of Arak University of Medical Science
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
Arak university of medical science
Full name of responsible person
Dr. Sharareh Khosravi
Position
Nursing Ph.D.
Other areas of specialty/work
Street address
Amir-al-momenin hospital, Basij square, Sardasht, Arak, Iran
City
Arak
Postal code
Phone
+98 86 3417 3503
Fax
Email
shararehkh2011@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak university of medical science
Full name of responsible person
Dr. Sharareh khosravi
Position
Nursing, Ph.D.
Other areas of specialty/work
Street address
Amir-al-momenin hospital, Basij square, Sardasht, Arak, Iran
City
Arak
Postal code
Phone
+98 86 3417 3503
Fax
Email
shararehkh2011@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Science
Full name of responsible person
Zaynab Vafa Arani
Position
B.Sc.
Other areas of specialty/work
Street address
No. 11, Amir Kabir St.
City
Aran & Bidgol
Postal code
8741646456
Phone
+98 31 5472 3165
Fax
Email
zvafa62@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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