IRCT2013091614679N1CompletedPhase 1
Effects of oral administration of Carum Copticum product compared to placebo in reducing symptoms of bloating and flatulence
Vice chancellor for research of Tehran University of Medical Sciences0 sites108 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 108
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 years to 49 years (—)
- Sex
- All
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.
Exclusion Criteria
- Not provided
Investigators
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