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IRCT2015092724228N1 IRCT 2016-06-03 Vice Chancellor for research of Kerman University of Medical Sciences Effect of Apium Graveolence and Trachyspermum Copticum traditional product on clinical symptoms of patients with Functional Dyspepsia Clinical trial of compared of Apium Graveolence and Trachyspermum Copticum traditional product effect with placebo and omeprazol on clinical symptoms of 18 to 60 years old patients with Functional Dyspepsia 2015-12-22 anticipated 150 Complete https://irct.ir/trial/20501 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2-3 Functional Dyspepsia. Intervention 1: Apium Graveolense beans 250 mg plus Trachyspermum Copticum beans 250 mg, two times daily,after meal. Intervention 2: Corn starch 500 mg, two times daily, after meal. Intervention 3: Omeprazol 20 mg, daily.
public Azimidehali Maryam
Shafa Crossroad; Jomhuri Boulevard; Kerman
Kerman Iran (Islamic Republic of) +98 34 3312 2050 m_azimidehali@collegian.kmu.ac.ir, dr.azimm@gmail.com Kerman University of Medical Science scientific Dr. Zahedi Mohammad Javad
Shafa Crossroad; Jomhuri Boulevard; Kerman
Kerman Iran (Islamic Republic of) +98 34 3121 5600 Zahedi@yahoo.com Kerman University of Medical Science Iran (Islamic Republic of) Inclusion criteria are 18 to 60 year-old patients with Functional Dyspepsia, without organic disorders on physical examination and endoscopy Exclusion criteria are Pregnancy and Lactation; History of convulsion; Active UTI; Use of chemical and herbal drugs of functional dyspepsia; use of anticoagulant drug;serious diseases like diabetes and cardiovascular diseases, Esophagus and gastrointestinal surgery, severe mental retardation, drug abuse, patient’s unwillingness to continue the project, not filling out the consent form History of peptic ulcer or reflux disease; Alarm sign (Weight loss, Anemia, Bloody stool, Dysphagia,etc 18 years 60 years Both K30 Indigestion Treatment - Drugs Placebo Treatment - Drugs Apium Graveolense beans 250 mg plus Trachyspermum Copticum beans 250 mg, two times daily,after meal Corn starch 500 mg, two times daily, after meal Omeprazol 20 mg, daily Severity assessment of dyspepsia. Timepoint: During 8 weeks follow up study. Method of measurement: The gastrointestinal symptom scale. Quality of life. Timepoint: At baseline, 2, 4, 8 weeks. Method of measurement: NDI10 quality of life scale. Side effects. Timepoint: During 12 weeks follow up study. Method of measurement: Questionnair. Vice Chancellor for research of Kerman University of Medical Sciences Approved 2015-08-25 Ethics Committe of Kerman University of Medical Sciences Shafa Crossroad; Jomhuri Boulevard; Kerman kerman Iran (Islamic Republic of)