The main purpose of this study is assessment of effects of Satureja hortensis L. (savory) in adult gastroesophageal reflux (GERD). Design: Double blind randomized clinical trial. This study is done on the 60 patients (18 to 65 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,...). All patients are examined by a gastroenterologist. Patients with risk of peptic ulcer or malignancy, as well as pregnant and breast feeding women are excluded. The patients are divided in two groups randomly. The first group receive S. hortensis capsules (one capsule three times a day for 4 weeks), the second group receive placebo capsules (one capsule three times 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 (FSSG). Finally both groups will be compared according to their score.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015072215860N2
Registration date:2015-07-30, 1394/05/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-30, 1394/05/08
Registrant information
Name
Ghazaleh Heydarirad
Name of organization / entity
School of Traditional Medicine, Traditional Medicine and Materia Medica Research Center, Shahid Behe
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 6027
Email address
dr.ghazalrad@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Colorectal Research Center,Rasoul Akram Hospital
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment effects of Satureja hortensis L. (savory) in adult gastroesophageal reflux (Randomized, double blind)
Public title
Assessment effects of savory on treatment of gastroesophageal reflux disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having the classic symptoms of reflux, patients with 18 to 65 years old, the normal examination by a gastroenterologist
Exclusion criteria: smoking, ongoing alcohol users, OB positive, risk of peptic ulcer or cancer, pregnant women, breast feeding women, any digestive disorder which requires new protocols, significant surgical or medical disorders clinically, hospitalization, and do not use of S. hortensis capsules for 2 weeks.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Iran University of Medical Sciences Ethics Committee
Street address
Iran University of Medical Sciences,West Shahid Hemmat Highway,Intersection of Chamran and Sheikh Fazlollah Noori
City
Tehran
Postal code
1449614535
Approval date
2015-06-30, 1394/04/09
Ethics committee reference number
IR.IUMS.REC.1394.25868
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 intervention and four weeks after starting the intervention
Method of measurement
visual analogue scale, frequency scale for symptoms of gastroesophageal reflux disease
Secondary outcomes
empty
Intervention groups
1
Description
Case group1: S. hortensis capsules (one capsule three times a day for 4 weeks, before meal)
Category
Treatment - Drugs
2
Description
Placebo capsules (one capsule three times a day for 4 weeks, before meal)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasaul Akram Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Colorectal Research Center,Rasoul Akram Hospital
Full name of responsible person
Doctor Shahram Agah
Street address
Sattarkhan Street, Niayesh Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Colorectal Research Center,Rasoul Akram Hospital
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
Colorectal Research Center, Rasoul Akram Hospital
Full name of responsible person
Ghazaleh Heydarirad
Position
MD, PhD
Other areas of specialty/work
Street address
Colorectal Research Center, Rasoul Akram Hospital,Niayesh street,Sattarkhan Street
City
Tehran
Postal code
Phone
+98 21 6655 4790
Fax
Email
dr.ghazalrad@sbmu.ac.ir - ghazalrad@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Colorectal Research Center, Rasoul Akram Hospital
Full name of responsible person
Amir Hossein Faghihi Kashani
Position
Gastroenterologist and Hepatologist, Associate Professor
Other areas of specialty/work
Street address
Colorectal Research Center, Rasoul Akram Hospital,Niayesh Street,Sattarkhan Street
City
Tehran
Postal code
Phone
+98 21 6655 4790
Fax
Email
ahfaghihi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Colorectal Research Center, Rasoul Akram Hospital
Full name of responsible person
Ghazaleh Heydarirad
Position
MD, PhD
Other areas of specialty/work
Street address
Colorectal Research Center, Rasoul Akram Hospital,Niayesh Street,Sattarkhan Street
City
Tehran
Postal code
Phone
+98 21 6655 4790
Fax
Email
dr.ghazalrad@sbmu.ac.ir - ghazalrad@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)