The main purpose of this study is to compare the effect of Myrtus C ommunis L. (Myrtle) fruit with the standard treatment of Gastroesophageal reflux disease (GERD). Design: Double blind randomized clinical trial. This study is done on the 43 patients (18 to 50 years old) that have classic symptoms of GERD (heart burn that sometimes get better after eating food or anti acid drugs, sour taste in the mouth, feeling heavy after or before meal, feeling full while eating food,...). For all of the patients upper gastroesophageal endoscopy is done. The patients with ulcer in esophagus or stomach are excluded. The patients are divided in three groups randomly. The first group receive Myrtus C ommunis L. (Myrtle) fruit ( one capsule twice a day for 4 weeks), the second group receive Omeprazole( one capsule once a day for 4 weeks) and the third group receive Myrtus C ommunis L. (Myrtle) fruit ( one capsule twice a day for 4 weeks) with Omeprazole (one capsule once a day for 4 weeks). The patients are visited before and after treatment and their symptoms are scored according the VAS system and the frequency scale for the symptoms of gastroesophageal reflux questionnaire. Finally all groups will be compared according to their score.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012072710410N1
Registration date:2013-02-10, 1391/11/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-02-10, 1391/11/22
Registrant information
Name
Rahimeh Akrami
Name of organization / entity
Shiraz University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 7589
Email address
akrami@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Shiraz University of Medical Sciences
Expected recruitment start date
2012-07-22, 1391/05/01
Expected recruitment end date
2012-10-22, 1391/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Double blind randomized clinical trial in treatment of gastroesophageal reflux disease with Myrtus Communis L. (Myrtle) fruit vs. omeprazole
Public title
Assessment the Effect of Myrtus Communis L. (Myrtle) fruit in treatment of gastroesophageal reflux disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having the classic symptoms of reflux; patients with 18-50 years old. Exclusion criteria: suffering from another disease; ongoing alcohol users; weakly cooperative patients; pregnant women; breast feeding women; women in fertility ages without any contraceptive method; diabetic patients;, erosive GERD; smoker patients.
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
43
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Zand street
City
Shiraz
Postal code
197871345
Approval date
2012-01-21, 1390/11/01
Ethics committee reference number
5900-90-CT
Health conditions studied
1
Description of health condition studied
gastroesophageal reflux
ICD-10 code
K21.9
ICD-10 code description
gastroesophageal reflux without esophagitis
Primary outcomes
1
Description
reflux symptoms
Timepoint
before intenvention and four weeks after starting the intervention
Method of measurement
visual analogue scale , frequency scale for symptoms of gastroesophageal reflux disease
Secondary outcomes
1
Description
headache after reflux
Timepoint
before intervention and four weeks after intervention
Method of measurement
according Statements
Intervention groups
1
Description
Control group: omeprazole capsule (once a day before breakfast)
Category
Treatment - Drugs
2
Description
Case group1: Myrtus Communis L. (Myrtle) fruit capsule (twice a day, before breakfast and dinner).
Category
Treatment - Drugs
3
Description
Case group2: Myrtus Communis L. (Myrtle) fruit capsule (twice a day, before breakfast and dinner) + omeprazole capsule (once a day before breakfast).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari Clinic
Full name of responsible person
Dr. Kazem Hosseini Asl
Street address
Zand street, Namazi square
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Hatam
Street address
Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Rahimeh Akrami
Position
MD, Taditional Medicine Resident
Other areas of specialty/work
Street address
Zand Street
City
Shiraz
Postal code
713451978
Phone
+98 71 1230 5410
Fax
Email
akrami@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Traditional medicine research center of Shiraz university of medical sciences
Full name of responsible person
Dr. Kazem Hosseini Asl, GI man
Position
Gastroentrologist
Other areas of specialty/work
Street address
Zand Street
City
Shiraz
Postal code
713451978
Phone
+98 71 1230 5410
Fax
+98 71 1647 4316
Email
hoseiniasl@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Rahimeh Akrami
Position
MD, Taditional Medicine Resident
Other areas of specialty/work
Street address
Zand Street
City
Shiraz
Postal code
713451978
Phone
+98 71 1230 5410
Fax
+98 71 1233 8476
Email
akrami@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)