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IRCT2016061428469N1 IRCT 2017-06-27 Vice chancellor for research,School of Traditional Medicine, Tehran University of Medical Sciences Effects of Phyllanthus amblica in Non-erosive reflux disease Effects of Phyllanthus amblica (a Iranian traditional formula) in Non-erosive reflux disease 2016-07-11 anticipated 68 Complete https://irct.ir/trial/23105 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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. 2-3 Non-erosive gastroesophageal reflux disease (NERD). Intervention 1: Intervention group:Phyllanthus amblica tablet (two 500 mg tablets, two times a day for 4 weeks, after lunch and dinner). Intervention 2: Control group: placebo tablet (two 500 mg tablets, two times a day for 4 weeks, after lunch and dinner).
public Shahnaz Karkon Varnosfaderani
School of Traditional Medicine, Tehran University of Medical Sciences, Sarparast st, Taleqani st.
Tehran Iran (Islamic Republic of) +98 21 8899 3656 sh.karkon@gmail.com; sh-karkon@razi.tums.ac.ir School of Traditional Medicine, Tehran University of Medical Sciences (TUMS) scientific Dr.Mohsen Nasiri Tosi
Imam Khomeiny Hospital, Qarib st, Tehran
Tehran Iran (Islamic Republic of) 00 mohsen_nasiri@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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. 16 years 83 years Both K21.9 Gastroesophageal reflux disease without esophagitis Treatment - Drugs Treatment - Drugs Intervention group:Phyllanthus amblica tablet (two 500 mg tablets, two times a day for 4 weeks, after lunch and dinner) Control group: placebo tablet (two 500 mg tablets, two times a day for 4 weeks, after lunch and dinner) Pain or heartburn. Timepoint: At the begining, end of the Second week, end of the forth week. Method of measurement: Gastroesophageal reflux standard questionnaire. Acid regurgitasion /sour taste in the mouth. Timepoint: At the begining, end of the Second week, end of the forth week. Method of measurement: Gastroesophageal reflux standard questionnaire. Vice chancellor for research,School of Traditional Medicine, Tehran University of Medical Sciences Approved 2015-07-12 Ethics committee of Tehran University of Medical Sciences Tehran University of Medical Sciences, at the Corner of Ghods St., Keshavarz Blvd. Tehran Iran (Islamic Republic of)