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comparison of efficacy of pistacia atlantial oleoresin with that of placebo in treatment of patients with functional dyspepsia

Protocol summary

Study aim
comparison of efficacy of pistacia atlantial oleoresin with that of placebo in treatment of patients with functional dyspepsia in Baqiyatallah hospital in 2020
Design
Patients are randomly divided into two groups of 35. Famotidine tablets of 40 mg once daily are given to both groups. The other placebo is given in the same amount and in both forms of the drug in the form of tablets. Then, the patients are visited in the second and fourth weeks and the mentioned questionnaires are filled in each time. The study will be out
Settings and conduct
Patients are randomly divided into two groups of 35. Famotidine 40 mg tablets are given once a day to both groups. To one group coriander gum (0.9 g / day) per day and to the other group placebo of the same amount and both. The form of the drug is given in the form of tablets, then the patients are visited in the second and fourth weeks and the mentioned questionnaires are filled in each time. During this period, any unwanted side effects will be checked and if the patient does not tolerate, he will be excluded from the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria : Age 15 to 65 years Patients with ROME4 criteria including recurrent abdominal pain that recurs on average at least once a week for at least three months and abdominal pain associated with bowel movements and the frequency and appearance of bowel movements, any abdominal discomfort, any Abdominal discomfort species
Intervention groups
Famotidine 40 mg tablets are given to both groups once a day. One group is given coriander gum (0.9 g / day) per day and the other placebo is given the same amount and both forms of the drug as tablets.
Main outcome variables
Improves appetite, reduces nausea, reduces vomiting, reduces premature satiety.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210124050126N1
Registration date: 2021-02-16, 1399/11/28
Registration timing: prospective

Last update: 2021-02-16, 1399/11/28
Update count: 0
Registration date
2021-02-16, 1399/11/28
Registrant information
Name
Erfan Ashjaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 5503
Email address
dr.erfan.ashjaei@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of efficacy of pistacia atlantial oleoresin with that of placebo in treatment of patients with functional dyspepsia
Public title
comparison of efficacy of pistacia atlantial oleoresin with that of placebo in treatment of patients with functional dyspepsia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 15 to 65 years, Patients with ROME4 criteria including recurrent abdominal pain that recurs on average at least once a week for at least three months abdominal pain associated with bowel movements and the frequency and appearance of bowel movements any abdominal discomfort, any Abdominal discomfort species
Exclusion criteria:
IBS, PUD, GERD CHF, DM, ATHMA, COPD and, , , , Psychological diseases history of alcohol and opium addiction ,gastrointestinal surgery need for continuous use of cardiological drugs antihypertensive antipsychotic sedatives antibiotics corticosteroids
Age
From 15 years old to 65 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization Randomization unit: individual Randomization tool: Random number table
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of Medical Sciences
Street address
Tehran, vanak
City
تهران
Province
Tehran
Postal code
1435915371
Approval date
2021-01-09, 1399/10/20
Ethics committee reference number
IR.BMSU.BAQ.REC.1399.045

Health conditions studied

1

Description of health condition studied
Functional dyspepsia
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Flatulence, premature satiety, loss of appetite
Timepoint
2 and 4 weeks after starting to use L Pistacia atlantica gum
Method of measurement
Hong Kong Questionnaire

Secondary outcomes

1

Description
Quality of Life
Timepoint
2 and 4 weeks after the onset of gum
Method of measurement
Quality of Life Questionnaire sf-36

Intervention groups

1

Description
In this study, two groups of 35 persons will participate, which is a control group, treated with 9 grams of mastic gum (0.9gr / day) per day in 3 divided doses with famotidine 40 mg tablet daily to be.
Category
Treatment - Drugs

2

Description
Control group: Control group: In this study, a control group consisting of 35 people receiving placebo treatment with famotidine40 mg will receive daily.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah hospital
Full name of responsible person
morteza jodi chelansofla
Street address
Tehran,Vanak
City
tehran
Province
Tehran
Postal code
1435915371
Phone
+98 41 3740 5295
Email
saidejudi766@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
morteza jodichelansofla
Street address
Tehran, vanak
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 41 3740 5295
Email
saidejudi766@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah University of Medical Sciences
Proportion provided by this source
50
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

2

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
معاونت پژوهش دانشگاه بقیه الله عج
Street address
tehran,vanak, baqiyatallah univercity
City
tehran
Province
Tehran
Postal code
1435915371
Phone
+98 41 3740 5295
Email
saidejudi766@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah University of Medical Sciences
Proportion provided by this source
50
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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
morteza jodi chelansofla
Position
general practioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
tehran vanak
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 41 3740 5295
Email
saidejudi766@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
morteza jodi chelansolfa
Position
general practioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
tehran vanak
City
tehran
Province
Tehran
Postal code
1435915371
Phone
+98 41 3740 5295
Email
saidejudi766@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
erfan ashjaei
Position
general practioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
tehran vanak
City
tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 2676 3281
Email
dr.erfan.ashjaei@gmail.com

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
Coded data will be provided
When the data will become available and for how long
After analyzing and printing the results
To whom data/document is available
The main executors of the project
Under which criteria data/document could be used
With the permission of the person in charge of the project and at the request of the higher authorities to verify the data
From where data/document is obtainable
Project Manager
What processes are involved for a request to access data/document
Send an email to the scientific manager of the project and make a request with him
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