Functional bloating. Abdominal distension
Conditions
Interventions
Intervention 1: Group 1 will receive Dimethicone chewable tablets 40 mg and placebo of Zax capsules 400 mg after each meal for 2 weeks. They will not receive any medication for a week during the washo
Sponsors
Niak Pharmaceutical Company
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Conscious consent to participate in the study Symptoms of bloating include a feeling of bloating or visible abdominal distention in at least the last three months and with the onset of symptoms at least six months ago Frequent bloating at least one day a week (moderate to severe bloating intensity) Normal abdominal examinations Normal colonoscopy in people over 50 years of age in the last year before entering the study No irritable bowel syndrome, functional constipation, functional indigestion or other gastrointestinal dysfunction Normality of tests: CBC, ESR TSH, Ca, P and Stool exam for leukocyte, OB, OP (parasite in feces, occult blood and leukocytes) and AST, ALT, ALP, BUN, Cr, FBS TTGA (IgA) (for celiac disease). )
Exclusion criteria
Exclusion criteria: Pregnant or lactating women Sensitivity to one of the herbs that make up the product History of chronic inflammation or structural disorders of the gastrointestinal system such as IBD, known peptic or duodenal ulcer, gastrointestinal obstruction or symptomatic gallstones Chronic diseases such as diabetes, thyroid dysfunction and uncontrollable hypertension Serious systemic disease (heart, kidney, lung and liver failure) Lactose intolerance (lactase deficiency) Dangerous symptoms such as involuntary weight loss of more than 4 kg in the last three months and blood in the stool or melena or bloody vomiting in the last three months History of gastrointestinal surgery other than appendectomy, inguinal hernia or abdominal wall, cesarean section, hysterectomy and tubal ligation Cancer Use of drugs affecting gastrointestinal motility (such as surfactants, antispasmodics), laxatives and any herbal anti-flatulence medication in the two weeks before the study Take antibiotics one month before the start of the study Substance or alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The severity of bloating. Timepoint: 1. Time 0: The beginning of the study (face-to-face visit)2. Time 1: Two weeks after receiving the drug of stage 1 (face-to-face visit)3. Time 2: End of stage 1 drug course and one week washout, cross-sectional study and start of stage 2 drug treatment and reuse of drugs (face-to-face visit)4. Time 3: 2 weeks after receiving stage 2 medication (face-to-face visit)5. Time 4: First follow-up - 2 weeks after the end of the drug (telephone follow-up)6. Time 5: Second follow-up - 4 weeks after the end of the drug (telephone follow-up)7. Time 6: Third follow-up - 8 weeks after the end of the drug (face-to-face visit). Method of measurement: face-to-face visits and telephone follow-up.;The frequency of bloating. Timepoint: 1. Time 0: The beginning of the study (face-to-face visit)2. Time 1: Two weeks after receiving the drug of stage 1 (face-to-face visit)3. Time 2: End of stage 1 drug course and one week washout, cross-sectional study and start of stage 2 drug treatment and reuse of drugs (face-to-face visit)4. Time 3: 2 weeks after receiving stage 2 medication (face-to-face visit)5. Time 4: First follow-up - 2 weeks after the end of the drug (telephone follow-up)6. Time 5: Second follow-up - 4 weeks after the end of the drug (telephone follow-up)7. Time 6: Third follow-up - 8 weeks after the end of the drug (face-to-face visit). Method of measurement: the frequency of bloating. | — |
Secondary
| Measure | Time frame |
|---|---|
| Satisfaction of treatment. Timepoint: the end of the study. Method of measurement: questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Marzieh Qaraati
Gorgan University of Medical Sciences
Outcome results
None listed