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IRCT2013091614679N1 IRCT 2013-11-08 Vice chancellor for research of Tehran University of Medical Sciences Carum Copticum effect in the treatment of bloating Effects of oral administration of Carum Copticum product compared to placebo in reducing symptoms of bloating and flatulence 2013-02-19 anticipated 108 Complete https://irct.ir/trial/14237 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: In a double-blind, placebo-controlled clinical trial, neither the patients nor the researchers know who is getting a placebo and who is getting the treatment. 1 bloating. Intervention 1: Control group:Our placebo is corn starch oral capsules which should be taken three times daily,one capsule after every meal for a month. Intervention 2: Intervention group:Our drug is carum capticum seed oral capsules which should be taken three times daily,one capsule after every meal for a month. Intervention 3: .
public Maryam Yazdian
South side of City Park, Behesht St., Vahdate Eslami St.
Tehran Iran (Islamic Republic of) +98 21 5569 3520 ma_yazdian@yahoo.com Vice chancellor for research of Traditional Medicine Faculty of Tehran University of Medical Science scientific Doctor Bagher Minaye
South side of City Park, Behesht St., Vahdate Eslami St.
Tehran Iran (Islamic Republic of) +98 21 5560 1274 minaezb@sina.tums.ac.ir Traditional Medicine Faculty of Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: age of 18 to 49 years, symptoms of flatulence, bloating or feeling of abdominal distention in the last three months with symptom onset at least six months prior to the study, normal abdominal examination, normal blood and stool tests including CBC, ESR, TSH, Ca, P, ALT, AST, Alph, BUN, Cr, FBS, TTGA, Stool exam (OB, OP, Leukocyte). Exclusion criteria :History of chronic or structural disorders of the gastrointestinal tract such as irritable bowel disease, peptic or duodenal ulcer disease, gastrointestinal obstruction, symptomatic gallbladder stone, serious clinical conditions, diabetes, thyroid gland disease, serious systemic disease (including heart , renal , lung and liver failure), uncontrollable high blood pressure, major psychiatric disorders, diagnosis of lactase deficiency or relieving symptoms by lactase free diet, alarm signs such as involuntarily weight loss more than 4.5 kg in the last three months, blood detection in the stool or melena or hemoptysis in the last three months, gastrointestinal surgery other than appendectomy, Hernioplasty, inguinal, abdominal wall surgery, cesarean section, hysterectomy and tubal ligation, masticatory disorders, cancer, drugs affecting the movement of the digestive tract such as surfactants, antispasmodic, osmotic laxatives, bulking agents, dopamine antagonists, muscarinic antagonist, 5HT4 and 5HT1 and 5HT3 agonists, antibiotics, opioids, anti-diarrheal medication, symbiotics, antimitotics (eg colchicine), anticholinergics, narcotics, antidepressants, anticonvulsants and any antiflatulance herbal medication two weeks before and during the study, taking antibiotics one month before starting the study, drug or alcohol abuse, lactating and pregnant women. 18 years 49 years Both K31 Diseases of oesophagus,stomach and duodenum Placebo Treatment - Drugs Treatment - Drugs Control group:Our placebo is corn starch oral capsules which should be taken three times daily,one capsule after every meal for a month Intervention group:Our drug is carum capticum seed oral capsules which should be taken three times daily,one capsule after every meal for a month Bloating, abdominal pain, flatulence, eructation, borborygmi, gas incontinence. Timepoint: before intervention, one month after starting the trial,one month after the end of trial. Method of measurement: Likert scale. Side effects. Timepoint: one month after starting the trial. Method of measurement: questionnaire. Vice chancellor for research of Tehran University of Medical Sciences Approved 2013-02-03 Ethics committee of Tehran University of Medical Sciences No.9, Pirnya Alley, Lalezar St., Jomhoori St. Tehran Iran (Islamic Republic of)