Formulation and evaluation of the efficacy of Myrtus communis syrup in patients with Functional Dyspepsia, A randomized double bind controlled clinical trial
Formulation and Evaluation of the Efficacy of Myrtus communis syrup in patients with Functional Dyspepsia, a randomized double bind controlled clinical trial
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 1 on 60 patients
Settings and conduct
This study is conducted in Ajlaliah Clinic of Kermanshah University of Medical Sciences randomly on 46 patients including intervention and control groups. Blinding is performed for patients, clinical caregivers and outcome assessors. Randomization is done using blocks of 4 and 6.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age should be more than 18 years and less than 80 years
Body mass index should be between 18 and 35 height per square meter
The patient has not been treated with myrtus communis syrup in the past month
The disease is suffering from dyspepsia whose type of disease is fully confirmed through complete medical examination, pathology and laboratory information
Exit criteria:
cancer patients
Intervention groups
Participants are divided into two treatment and control groups:
The patients of the treatment group are treated with 5 cc of Myrtus communis syrup per day along with the standard drug (dimethicone) for one month, and the patients of the control group are treated with the standard drug alone.
Disease severity and efficacy parameters are evaluated at the beginning (before the intervention) and at the end of the treatment period (after one month).
Main outcome variables
Flatulence, stomach pain, nausea, Esophagitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231005059633N1
Registration date:2023-11-04, 1402/08/13
Registration timing:prospective
Last update:2023-11-04, 1402/08/13
Update count:0
Registration date
2023-11-04, 1402/08/13
Registrant information
Name
Negin Najafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3720 2523
Email address
najafi.ne1998@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-11, 1402/08/20
Expected recruitment end date
2024-02-09, 1402/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Formulation and evaluation of the efficacy of Myrtus communis syrup in patients with Functional Dyspepsia, A randomized double bind controlled clinical trial
Public title
Effect of Myrtus communis syrup in treatment of Functional Dyspepsia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age should be more than 18 years and less than 80 years
Body mass index should be between 18 and 35 height per square meter
The patient has not been treated with myrtus communis syrup in the past month
The disease is suffering from dyspepsia whose type of disease is fully confirmed through complete medical examination, pathology and laboratory information
Exclusion criteria:
cancer patients
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we divide 2 groups that meet the inclusion criteria completely randomly. The randomization process is done using blocks of 4 and 6, and the blocking will be done by the online randomization software www.sealedenvelope.com
Blinding (investigator's opinion)
Double blinded
Blinding description
The double-blind method is used for blinding. The list of intervention groups specified in this process remains with the coordinator. The person responsible for evaluating entry/exit criteria and registering people will not know about this process. None of the patients and the evaluator will know the type of treatment.
Placebo
Not 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
School of pharmacy, Kermanshah university of medical sciences, Daneshgah st. shahid shiroodi Blv. kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2023-07-04, 1402/04/13
Ethics committee reference number
IR.KUMS.REC.1402.161
Health conditions studied
1
Description of health condition studied
Functional dyspepsia
ICD-10 code
K31.8
ICD-10 code description
Other specified diseases of stomach and duodenum
Primary outcomes
1
Description
flatulence
Timepoint
at the beginning of the study (before the intervention) and at the end of the study (after one month)
Method of measurement
Questionnaire
2
Description
stomach pain
Timepoint
at the beginning of the study (before the intervention) and at the end of the study (after one month)
Method of measurement
Questionnaire
3
Description
nausea
Timepoint
at the beginning of the study (before the intervention) and at the end of the study (after one month)
Method of measurement
Questionnaire
4
Description
Esophagitis
Timepoint
at the beginning of the study (before the intervention) and at the end of the study (after one month)
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For one month, they are treated with the fruit syrup of the plant in the amount of 5 cc per day along with 2 standard medicines (Dimethicone 40) per day
Category
Treatment - Drugs
2
Description
Control group: they are treated with standard drug (Dimethicone 40) in the amount of 2 tablets per day for one month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ejlalieh clinic of Kermanshah
Full name of responsible person
Dr. Mehdi Zubairi
Street address
Parking shahrdari, West moallem street, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714694451
Phone
+98 993 120 0943
Email
najafi.ne1998@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hossein Farzaei
Street address
School of pharmacy, Kermanshah university of medical sciences, Daneshgah st. shahid shiroodi Blv. kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6743667149
Phone
+98 918 339 3351
Email
mh_farzaee@razi.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Negin Najafi
Position
Pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
School of pharmacy, Kermanshah university of medical sciences, Daneshgah st. shahid shiroodi Blv. kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714694451
Phone
+98 993 120 0943
Email
najafi.ne1998@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hossein Farzaei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
School of pharmacy, Kermanshah university of medical sciences, Daneshgah st. shahid shiroodi Blv. kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714694451
Phone
+98 918 339 3351
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
Negin Najafi
Position
Pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
School of pharmacy, Kermanshah university of medical sciences, Daneshgah st. shahid shiroodi Blv. kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714694451
Phone
+98 83 3720 2523
Email
najafi.ne1998@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
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