Determination of the effect of mint extract on the severity of symptoms in patients with irritable bowel syndrome
Design
A randomized controlled trial clinical trial with parallel, double-blind, randomized groups.
Settings and conduct
This study is carried out at the Gastroenterology Clinic of Amiralmomenin Hospital. Samples will be selected from patients with irritable bowel syndrome. Then they are randomly divided into two groups of intervention and control.The intervention group, in addition to the usual treatments, received 10 drops of Barijan Mint extract twice daily for one month after lunch and dinner. The control group, in addition to the usual treatments, received 10 placebo drops twice daily for lunch and dinner for one month. The study is a double blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Willingness to participate in the study, ages 18 to 65, Gastrointestinal intestinal syndrome is diagnosed by a gastroenterologist.
Exclusion criteria: record of any major bowel surgery, metabolic or other diseases, taking corticosteroid drugs, taking of steroidal anti-inflammatory drugs.
Intervention groups
Group 1 (intervention): in addition to the medications prescribed by the physician, the amount of 10 drops of mint extract of Barij Essence Company is given twice a day after lunch and dinner for one month. Group 2 (placebo): in addition to the medications prescribed by the physician, are given placebo (colored water), the amount of 10 drops is given twice a day after lunch and dinner for one month.
Main outcome variables
Severity of symptoms of irritable bowel syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130731014229N10
Registration date:2019-10-31, 1398/08/09
Registration timing:registered_while_recruiting
Last update:2019-10-31, 1398/08/09
Update count:0
Registration date
2019-10-31, 1398/08/09
Registrant information
Name
Hadi Jafari manesh
Name of organization / entity
Arak University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3503
Email address
jafarimanesh@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Peppermint (Mentha Piperita) with placebo on severity of symptoms in patients with irritable bowel syndrome
Public title
Effect of Peppermint (Mentha Piperita) on severity of symptoms in patients with irritable bowel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The desire to participate in the study
Aged 18 to 65
Gastrointestinal intestinal syndrome is diagnosed by a gastroenterologist
Exclusion criteria:
history of any major bowel surgery
metabolic diseases or other diseases
taking corticosteroids
taking Non-steroidal anti-inflammatory drugs
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are randomly assigned to quadruple blocks A, A, B, B in random groups. So that 8 blocks of 4 letters A and B are made up.Then a block is randomly selected. A indicates sample placement in intervention group and B indicates sample placement in control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and data analyzer do not know which groups are located. The samples in the intervention and control group did not know whether they received the placebo or the main drug. The statistician will receive questionnaires as anonymously and in form A and B, and he does not know which are intervention and control group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Basij Sq.
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2019-05-05, 1398/02/15
Ethics committee reference number
IR.ARAKMU.REC.1398.083
Health conditions studied
1
Description of health condition studied
Irritable bowel syndrome
ICD-10 code
K58
ICD-10 code description
Irritable bowel syndrome
Primary outcomes
1
Description
Severity of symptoms of irritable bowel syndrome
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Gastrointestinal Symptom Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in addition to the medications prescribed by the physician, the amount of 10 drops of mint extract of Barij Essence Company is given twice a day after lunch and dinner for one month.
Category
Treatment - Drugs
2
Description
Control group: in addition to the medications prescribed by the physician, are given placebo (colored water), the amount of 10 drops is given twice a day after lunch and dinner for one month.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastroenterology Clinic of Amiralmomenin Hospital.
Full name of responsible person
Hadi Jafarianesh
Street address
Basij Sq.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3503
Email
nurse_science@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad ََArjomandzadega
Street address
Deputy of Research and Technology, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3503
Email
nurse_science@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hadi Jafarianesh
Position
Faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Basij Sq. Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3503
Email
nurse_science@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hadi Jafarimanesh
Position
Faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Basij Sq. Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3503
Email
nurse_science@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hadi Jafarimanesh
Position
Faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Basij Sq. Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 34173503
Email
nurse_science@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available