The aim of the project is to prepare a herbal medicine with minimal side effects in controlling reflux symptoms so as to lessen the consumption of chemical drugs and to minimize the side effects thereof.
The project is randomized, double-blind, placebo-controlled, and multi-center. People of 20-60 years old whose disease has recently been diagnosed or those who have not received medications during the past 2 months are enrolled in the study, provided that reflux symptoms (heartburn or regurgitation) would occur at least twice a week. People with high levels of creatinine and urea and/or liver enzymes are not enrolled. Those patients who take nonsteroidal anti-inflammatory drugs (NSAIDs), Digoxin, Cisapride, anti-arrhythmic and antiplatelet drugs are not entered in the study.
A total of 80 patients are divided into two 40-member groups. The medicine is 10% extract syrup of Crataegus oxycantha prepared according to the United State Pharmacopia (USP) formulation. Preparation of the placebo is also based on the same formulation—but without the extract syrup of Crataegus oxycantha.
One group is treated with the herbal medicine and the other with the placebo. Subsequent to each meal 5 ml of the syrup, either herbal medicine or placebo, should be taken by the participants of both groups. At the end of the 2nd and 4th weeks the symptoms (heartburn and regurgitation) are assessed and the results are compared across the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013081314345N1
Registration date:2013-12-25, 1392/10/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-25, 1392/10/04
Registrant information
Name
Fatemeh Moini
Name of organization / entity
School of Traditional Medicine, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2640 5680
Email address
f-moini@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
School of Traditional Medicine, Tehran University of Medical Sciences (TUMS)
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-02-19, 1392/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of 10% extract syrup prepared from Crataegus oxycantha versus placebo on gastroesophageal reflux disease (GERD) symptoms
Public title
Effect of Crataegus oxycantha on gastroesophageal reflux disease (GERD) symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with reflux symptoms (heartburn or regurgitation) occurring at least 2 days a week; patients with uncomplicated reflux; newly diagnosed patients or diagnosed patients who have not used any drugs within the past 2 months.
Exclusion criteria: Patients with high urea and creatinine levels; patients with elevated liver enzymes; patients who need to use nonsteroidal anti-inflammatory drugs (NSAIDs) daily; patients who use cardiac glycosides (Digoxin), antiarrhythmic drugs, antiplatelet drugs or Cisapride.
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:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The project is a double-blind study wherein both the medicine and the placebo are poured in identical containers coded by a pharmacist to be provided for the researcher. Neither is the researcher aware of the contents of each container nor do the patients know if they have taken medicine or placebo.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Institude of Islamic and Complementory Medicine, Iran University of Medical Sciences
Street address
Pirnia Alley, Lalehzar Street, Jomhoori Street
City
Tehran
Postal code
Approval date
2013-05-23, 1392/03/02
Ethics committee reference number
113/ط م/26پ
Health conditions studied
1
Description of health condition studied
Gastroesophageal Reflux Disease
ICD-10 code
k21.9
ICD-10 code description
Gastro-oesophageal reflux disease without oesophagitis
Primary outcomes
1
Description
Heartburn, Regurgitasion
Timepoint
At first, end of the second week, end of the forth week
Method of measurement
Clinical; how many days a week a patient suffers from the symptoms
Secondary outcomes
1
Description
Dysphagy, Chest Pain and Cough
Timepoint
At first, end of the second week, end of the forth week
Method of measurement
Clinical; how many days a week a patient has the symptoms
Intervention groups
1
Description
The patients in case group are treated with the drug (10% extract syrup of Crataegus oxycantha); they should drink 5 ml of the medicine after meal for 4 weeks.
Category
Treatment - Drugs
2
Description
The patients in control group are treated with the placebo and they should take 5 ml of the placebo after meal for 4 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastrointestinal Clinic of Imam Khomeiny and Hazrat Rasoul Hospitals
Full name of responsible person
Fatemeh Moini
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
School of Traditional Medicine, Tehran University of Medical Sciences
Full name of responsible person
Ms. Talaee Zadeh
Street address
Traditional Medicine College, Behesht Street, Hafez Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of Traditional Medicine, 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
School of Traditional Medicine, Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Moini
Position
Physician, PhD student
Other areas of specialty/work
Street address
Traditional Medicine Clinic, Jamali Alley, Vafamanesh Street, Heravi Square
City
Tehran
Postal code
1919846564
Phone
+98 21 2298 8551
Fax
+98 21 8879 2692
Email
farmoini@yahoo.com; f-moini@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Medicine, Tehran University of Medical Sciences
Full name of responsible person
Najmeh Aletaha
Position
Gastrointestinal subspecialist, Assistant Professor