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Evaluation of the effectiveness of Cinnamon Oil Soft Capsule on Bloating in patients with Functional Dyspepsia

Protocol summary

Study aim
The goal of this randomized double blind placebo controlled clinical trial is to prescribe Cinnamon oil soft capsule for functional dyspepsia patients and evaluation of the efficacy of this natural remedy.
Design
In this research, 68 patients will be treated randomly with either Cinnamon oil soft capsule (intervention) or placebo (control) three times a day for 6 weeks. Each time, 1 capsule is used.
Settings and conduct
This study is done in Imam Reza hospital of Kermanshah University of Medical Sciences. Blinding is done for patients and physician who measure the outcome of the study. Randomization is performed using blocking method.
Participants/Inclusion and exclusion criteria
Major inclusion criteria include: 18<age<80; patients who sign the testimonials and cooperate during the study and patients who have not been treated with Cinnamon oil soft capsule during the last month, and main exclusion criteria include: Patients with peptic ulcer disease, inflammatory bowel disease, irritable bowel syndrome, pure gastro-esophageal reflux disease; Patients with a history of gastrointestinal system surgery and pregnant and breast-feeding women.
Intervention groups
Intervention: oral use of Cinnamon oil soft capsule three times a day for 6 weeks. Control: oral use of Sesame oil soft capsule three times a day for 6 weeks.
Main outcome variables
Bloating

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170802035460N2
Registration date: 2017-12-29, 1396/10/08
Registration timing: registered_while_recruiting

Last update: 2017-12-29, 1396/10/08
Update count: 0
Registration date
2017-12-29, 1396/10/08
Registrant information
Name
Fateme Parvizi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3429 9220
Email address
fatemeparvizi4@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of Cinnamon Oil Soft Capsule on Bloating in patients with Functional Dyspepsia
Public title
Effect of Cinnamon Oil Soft Capsule on Functional Dyspepsia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 80 Patients who sign the testimonials and cooperate during the study Patients who have not been treated with Cinnamon Oil Soft Capsule during the last month Patients who their diseases are confirmed by complete medical evaluation including colonoscopy, pathology and laboratory data
Exclusion criteria:
Patients with peptic ulcer disease, inflammatory bowel disease, irritable bowel syndrome, pure gastro-esophageal reflux disease Biliary motility disorder and any organic gastrointestinal disease Patients with a history of gastrointestinal system surgery Patients with background systemic diseases such as diabetes mellitus, heart failure, hepatic failure, renal failure, asthma, chronic obstructive pulmonary disease Patients with severe psychiatric diseases Patients addicted to alcohol and opium pregnant and breast-feeding women Taking any routine medication such as cardiac, antihypertensive, antipsychotic, antianxiety, corticosteroids drugs, Iron or calcium supplements and antibiotics
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 68
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is performed using blocking method.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding is done for patients and physician who measure the outcome of the study.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences, Faculty of pharmacy,Daneshgah Ave., Shahid Shiroodi Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2017-11-25, 1396/09/04
Ethics committee reference number
KUMS.REC.1396.448

Health conditions studied

1

Description of health condition studied
functional dyspepsia
ICD-10 code
K30
ICD-10 code description
Functional dyspepsia

Primary outcomes

1

Description
Bloating
Timepoint
At the beginning of the study, 2, 4 and 8 weeks after starting the soft capsule of cinnamon oil
Method of measurement
Gastrointestinal Symptom score

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: use a soft capsule of cinnamon oil three times a day for 6 weeks
Category
Treatment - Drugs

2

Description
Control group: oral use of Sesame oil soft capsule three times a day for 6 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Mohammad Hosein Farzaei
Street address
Imam Reza Hospital, Parastar Blvd., Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714415333
Phone
+98 83 3825 0271
Email
mh-farzaee@razi.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mohamad Hosein Farzaee
Street address
Kermanshah University of Medical Sciences, Faculty of pharmacy,Daneshgah Ave., Shahid Shiroodi Blv., Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6734667149
Phone
+98 83 3825 0271
Email
mh-farzaee@razi.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Fateme Parvizi
Position
Investigator
Latest degree
Master
Other areas of specialty/work
Others
Street address
Kermanshah University of Medical Sciences, Daneshgah St., Sorkheligheh, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714694451
Phone
+98 83 3429 9220
Fax
Email
fatemeparvizi4@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hosein Farzaei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Kermanshah University of Medical Sciences, Faculty of pharmacy, Daneshgah Ave., Shahid Shiroodi Blv., Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6734667149
Phone
+98 83 3426 6780
Email
mh-farzaee@razi.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Fateme Parvizi
Position
Investigator
Latest degree
Master
Other areas of specialty/work
Others
Street address
Kermanshah University of Medical Sciences, Daneshgah St., Sorkheligheh, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714694451
Phone
+98 83 3429 9220
Fax
Email
fatemeparvizi4@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not 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
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