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The effect of Shirazi thyme essential oil on the clinical symptoms of patients with gastroesophageal reflux disease

Protocol summary

Study aim
Determining the effect of Shirazi thyme essential oil on the clinical symptoms of patients with gastroesophageal reflux
Design
A clinical trial with a control group, with parallel groups, without blinding, randomization, phase 3, on 70 patients, was used to randomize the table of random numbers.
Settings and conduct
The present study is a two-group randomized clinical trial. The patients with gastroesophageal reflux referring to Allameh Bahloul Gonabadi Hospital, Gonabad City, are the studied community. After obtaining informed consent, the demographic questionnaire and the reflux disease questionnaire will be distributed among the samples and completed by them. In the control group, no intervention is performed for the patients, and for these patients, educational and therapeutic measures are performed normally. In the intervention group, two gastrolith capsules containing Shirazi thyme essential oil are given to the patients after lunch and dinner for 6 weeks. After the end of the study, the patients will complete the reflux disease questionnaire again and finally the collected data will be analyzed using SPSS version 22 software.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients between 20 and 60 years old with second-degree gastroesophageal reflux disease who were unable to resolve the symptoms with lifestyle changes. And they did not have gastrointestinal bleeding or surgery during the study. Exclusion criteria: patients who do not want to participate in the study or are admitted to the hospital during the study.
Intervention groups
In the control group, no intervention is performed and these patients receive training and treatment as usual. In the intervention group, one gastrolith capsule containing Shirazi thyme essential oil was given to the patients daily for 6 weeks after lunch and dinner.
Main outcome variables
Severity of gastroesophageal reflux

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240116060709N1
Registration date: 2024-02-21, 1402/12/02
Registration timing: prospective

Last update: 2024-02-21, 1402/12/02
Update count: 0
Registration date
2024-02-21, 1402/12/02
Registrant information
Name
Benyamin Borhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5582 3445
Email address
benyaminborhani72@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-24, 1402/12/05
Expected recruitment end date
2024-03-10, 1402/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Shirazi thyme essential oil on the clinical symptoms of patients with gastroesophageal reflux disease
Public title
Investigating the effect of Shirazi thyme essential oil on the clinical symptoms of patients with gastroesophageal reflux
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to attend the study Patients with second grade reflux severity (patients who were not able to resolve their symptoms with lifestyle changes alone) Age 20 to 60 years Absence of pregnancy and breastfeeding Absence of allergy to thyme Not having diabetes No previous upper gastrointestinal surgery Absence of positive and clinically significant gastrointestinal bleeding in the last three months Absence of proven diseases such as: bleeding disorder, Barrett's Esophagus,esophageal varices, duodenal/stomach ulcer and upper gastrointestinal tract malignancy Able to read, understand and complete the questionnaire
Exclusion criteria:
Reluctance to continue research Hospitalization during the study Not using gastrolith capsules for more than 5 days
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
After the pre-test, patients are randomly assigned to one of the intervention or control groups based on the random numbers table. For this purpose, a list of patients with entry criteria is prepared and no intervention is performed in the control group and gastrolith capsules are consumed twice a day in the intervention group.
Blinding (investigator's opinion)
Not 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 Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Ghadir Square
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2023-07-19, 1402/04/28
Ethics committee reference number
IR.GMU.REC.1402.073

Health conditions studied

1

Description of health condition studied
Gastroesophageal reflux disease
ICD-10 code
K21.9
ICD-10 code description
Gastro-esophageal reflux disease without esophagitis

Primary outcomes

1

Description
Percentage of people with second-degree gastroesophageal reflux (patients who were not able to resolve their symptoms only by lifestyle changes)
Timepoint
Before the intervention and 45 days after the intervention
Method of measurement
Reflux disease questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: After completing the demographic questionnaire and gastric reflux disease questionnaire, one gastrolith capsule (containing 20 mg of Shirazi thyme essential oil, manufactured by Iran's Barij Essential Pharmaceutical Company) is given to the patients after noon and night meals for 6 weeks. After every 7 days, the use of Gastrolite capsules is stopped for 2 days, and after 2 days of non-use, the use of Gastrolite capsules is resumed. Drug consumption is controlled by telephone every week, after the end of the study, the patients will complete the reflux disease questionnaire again, and the patients who have not used Shirazi thyme essence capsules for 5 days will be excluded from the study.
Category
Treatment - Drugs

2

Description
Control group: After completing the demographic questionnaire and the gastric reflux disease questionnaire, no intervention is performed for the patients and for these patients the educational and treatment procedures are carried out normally.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Gonabad University of Medical Sciences
Full name of responsible person
Benyamin Borhani
Street address
Gonabad University of Medical Sciences, Ghadir Square
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3513
Fax
+98 51 5723 6160
Email
info@gmu.ac.ir
Web page address
https://www.gmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Leila Sadegh Moghadam
Street address
Gonabad University of Medical Sciences, Ghadir Square
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3513
Fax
+98 51 5723 6160
Email
info@gmu.ac.ir
Web page address
https://www.gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Benyamin Borhani
Position
Senior students
Latest degree
A Level or less
Other areas of specialty/work
Others
Street address
Gonabad University of Medical Sciences, Ghadir Square
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3513
Fax
+98 51 5723 6160
Email
benyaminborhani72@gmail.com
Web page address
https://www.gmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Habib Shareinia
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Gonabad University of Medical Sciences, Ghadir Square
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3513
Fax
+98 51 5723 6160
Email
Habibshareinia@gmail.com
Web page address
https://www.gmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Benyamin Borhani
Position
senior students
Latest degree
A Level or less
Other areas of specialty/work
Others
Street address
Gonabad University of Medical Sciences, Ghadir Square
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3513
Fax
+98 51 5723 6160
Email
Benyaminborhani72@gmail.com
Web page address
https://www.gmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All potential data can be shared once individuals are identified.
When the data will become available and for how long
The access period starts 6 months after the publication of the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Researchers working in academic and scientific institutions can apply for clinical use after coordination with the main researcher of this research.
From where data/document is obtainable
Name: Benyamin Borhani Phone number: 00989155355135 email: Benyaminborhani72@gmail.com Postal code: 9674110033
What processes are involved for a request to access data/document
After the request is announced by the requester, the request is reviewed and information is sent to the requester within one month.
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