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Evaluation the effect of Myrtus Communis L. (Myrtle) fruit syrup, Traditional Iranian Medicine compound, on relapsing of Gastro esophageal reflux disease in patients 20 to 60 years old: a double blinded randomized controlled trial.

Protocol summary

Summary
Purpose: Evaluation the effect of Myrtus Communis L. (Myrtle) fruit syrup on relapsing of Gastro esophageal reflux disease. Design: Randomized, double blind, placebo controlled, and multicentral. Population: Cases were selected from Traditional Clinics and Shariati Hospital. Inclusion criteria: Age between 20-60 years, reflux symptoms more than once a week. Exclusion criteria: Alarm signs, having severe complication, sensitivity to Myrtus Communis. Study size: Ninety, after selecting the patients and taking inform consent, were randomized into 2 groups, using random number tables. Intervention: Case group: Myrtus Communis L. (Myrtle) fruit syrup, 5 cc after each meal, Breakfast and Lunch and Dinner, and Omeprazole capsule 20mg with fasting, for 6 Weeks. Control group: Placebo syrup of Myrtle fruit, 5 cc after each meal, Breakfast and Lunch and Dinner and Omeprazole capsule 20mg with fasting, for 6 Weeks. After this time, the drug has been discontinued and relapsing symptoms after 2 weeks will be reviewed. Main outcome variable is relapsing of Gastro esophageal reflux disease.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014102719705N1
Registration date: 2015-05-10, 1394/02/20
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-05-10, 1394/02/20
Registrant information
Name
Mehdi Salehi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3331 8165
Email address
m_salehi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-01-05, 1393/10/15
Expected recruitment end date
2015-08-22, 1394/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of Myrtus Communis L. (Myrtle) fruit syrup, Traditional Iranian Medicine compound, on relapsing of Gastro esophageal reflux disease in patients 20 to 60 years old: a double blinded randomized controlled trial.
Public title
Effect of Myrtus Communis in Gastro esophageal reflux disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with 20-60 years old; having reflux symptoms more than once a week. Exclusion criteria: Liver failure; cancer; pregnant women; surgery on stomach or esophagus; significant weight loss in 3 last months; melena or hematemesis; IBD; using PPI in the past 1 month; frequent using of NSAIDs.; severe chest pain; BMI>40; unwillingness to cooperation in study; sever complication; sensitivity to Myrtus Communis
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Corner of Ghods St., Keshavarz Blvd., Tehran, Iran
City
Tehran
Postal code
Approval date
2014-11-09, 1393/08/18
Ethics committee reference number
9021309003-126388

Health conditions studied

1

Description of health condition studied
Gastro esophageal reflux disease
ICD-10 code
K21
ICD-10 code description
Gastro-oesophageal reflux disease

Primary outcomes

1

Description
Relapsing of Gastro esophageal reflux
Timepoint
At first, end of the sixth week, end of the eighth week
Method of measurement
Gastro esophageal reflux standard questionnaire

Secondary outcomes

1

Description
Heartburn
Timepoint
At first, end of the sixth week, end of the eighth week
Method of measurement
Gastro esophageal reflux standard questionnaire

2

Description
Acid regurgitation
Timepoint
At first, end of the sixth week, end of the eighth week
Method of measurement
Gastro esophageal reflux standard questionnaire

3

Description
Chestpain
Timepoint
At first, end of the sixth week, end of the eighth week
Method of measurement
Gastroesophageal reflux standard questionnaire

4

Description
Dysphagia
Timepoint
At first, end of the sixth week, end of the eighth week
Method of measurement
Gastroesophageal reflux standard questionnaire

Intervention groups

1

Description
Case group: Oral syrup of Myrtus Communis L. (Myrtle) fruit, 5 cc after each meal, Breakfast and Lunch and Dinner, and Omeprazole capsule 20mg with fasting, for 6 Weeks Myrtus Communis L. (Myrtle) fruit syrup contains 1 gr of Myrtle fruit extract in 5 cc syrup. Base of the syrup is water and sugar.
Category
Treatment - Drugs

2

Description
Control group: Placebo syrup of Myrtus Communis L. (Myrtle) fruit, 5 cc after each meal, Breakfast and Lunch and Dinner, and Omeprazole capsule 20mg with fasting, for 6 Weeks Intervention time is 6 Weeks for both groups and 2 Weeks after this time relapsing symptoms will be checked.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Dr. Mehdi Salehi
Street address
Shariati Hosp, North Karegar Ave., Tehran, IRAN
City
Tehran

2

Recruitment center
Name of recruitment center
Traditional Medicine Clinic
Full name of responsible person
Dr. Mehdi Salehi
Street address
Faculty of Traditional Medicine, Corner of Behesht St., Vahdat Eslami Ave., Tehran, IRAN
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Roja Rahimi
Street address
Faculty of Traditional Medicine, Corner of Behesht St., Vahdat Eslami Ave., Tehran, IRAN
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mehdi Salehi
Position
MD and PhD Student in Traditional Medicine
Other areas of specialty/work
Street address
Faculty of Traditional Medicine, Corner of Behesht St., Vahdat Eslami Ave., Tehran, IRAN
City
Tehran
Postal code
Phone
+98 21 3331 8165
Fax
+98 21 5560 1274
Email
m_salehi@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mehrdad Karimi
Position
Traditional Medicine Specialist
Other areas of specialty/work
Street address
Faculty of Traditional Medicine, Corner of Behesht St., Vahdat Eslami Ave., Tehran, IRAN
City
Tehran
Postal code
Phone
+98 21 5560 1274
Fax
+98 21 5560 1274
Email
mehrdadkarimi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mehdi Salehi
Position
MD and PhD Student in Traditional Medicine
Other areas of specialty/work
Street address
Faculty of Traditional Medicine, Corner of Behesht St., Vahdat Eslami Ave., Tehran, IRAN
City
Tehran
Postal code
Phone
+98 21 3331 8165
Fax
+98 21 5560 1274
Email
m_salehi@razi.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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