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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

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013091614679N1
Enrollment
108
Registered
2013-11-08
Start date
2013-02-19
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bloating. Diseases of oesophagus,stomach and duodenum

Interventions

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 i
Placebo
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

Sponsors

Vice chancellor for research of Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 49 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
Side effects. Timepoint: one month after starting the trial. Method of measurement: questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Yazdian

Vice chancellor for research of Traditional Medicine Faculty of Tehran University of Medical Science

ma_yazdian@yahoo.com+98 21 5569 3520

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026