The main purpose of this study is assessment of effects of phyllanthus amblica
in non-erosive reflux disease (NERD). Design: Double blind randomized clinical trial. This study is done on the 68 patients (16 to 80 years old) that have classic symptoms of NERD (heart burn, sour taste in the mouth, feeling heavy after or before meal,...) and normal endoscopy. 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 phyllanthus amblica tablets (two tablets two times a day for 4 weeks), the second group receive placebo tablets (two tablets two times a day for 4 weeks). phyllanthus amblica tablets and placebo produced in Faculty of Pharmacy Tehran University of Medical Sciences. The patients are visited before and after 2 and 4 weeks 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:IRCT2016061428469N1
Registration date:2017-06-27, 1396/04/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-27, 1396/04/06
Registrant information
Name
Shahnaz Karkonvarnosfaderani
Name of organization / entity
School of Traditional Medicine, Tehran University of Medical Sciences (TUMS)
Country
Iran (Islamic Republic of)
Phone
+98 21 7789 6093
Email address
sh-karkon@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,School of Traditional Medicine, Tehran University of Medical Sciences
Expected recruitment start date
2016-07-11, 1395/04/21
Expected recruitment end date
2016-12-05, 1395/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Phyllanthus amblica (a Iranian traditional formula) in Non-erosive reflux disease
Public title
Effects of Phyllanthus amblica in Non-erosive reflux disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having the classic symptoms of reflux disease and normal endoscopy; patients with 16 to 80 years old; the normal examination by a gastroenterologist Exclusion criteria: erosive esophagitis in endoscopy; 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; use of PPI for 10 days ago; and use of H2 blocker for 2 weeks ago.
Age
From 16 years old to 83 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The patients with classic symptoms of NERD (heart burn, sour taste in the mouth) and normal endoscopy that are examined by a gastroenterologist. The patients are given anti reflux diet for two weeks. The patients that did not better, are divided in two groups randomly. The first group receive phyllanthus amblica tablets, the second group receive placebo tablets. phyllanthus amblica tablets and placebo produced in Faculty of Pharmacy Tehran University of Medical Sciences. The patients are visited before and after 2 and 4 weeks treatment and their symptoms are noted.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, at the Corner of Ghods St., Keshavarz Blvd.