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The Effect of Ajwain fruit extract on Improvement of Irritable Bowel Syndrome (IBS) Symptoms

A Clinical Trial of the Effectiveness of Ajwain fruit extract on Inhibition of Irritable Bowel Syndrome (IBS) Symptoms and Its Comparison with Control Group

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20160306026938N8
Enrollment
80
Registered
2021-07-22
Start date
2021-07-10
Completion date
Unknown
Last updated
2021-08-30

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

Conditions

Irritable Bowel Syndrome (IBS). Irritable bowel syndrome

Interventions

Intervention 1: Intervention group: Oral prescription of a 100 mg capsule containing hydroalcoholic extract of Ajwain fruit, equal to 3 g of it and 400 mg auxiliary ingredients including lactose powd

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Adherence to diagnostic criteria of Irritable Bowel Syndrome (IBS) including recurrent abdominal pain at least three days in a month during past three months and beginning of symptoms at least from six months ago plus at least two conditions of three pain alleviation conditions after defecation, variations in number of defecation times and changes in stool consistency Age range of 18-70 years old Signing the informed consent

Exclusion criteria

Exclusion criteria: Being afflicted with any underlying disease pregnancy Being allergic to Apiaceae family plants Bowel dysfunctions including abnormal colonoscopy observations Lactation period Consumption of medications for improvement of irritable bowel syndrome symptoms

Design outcomes

Primary

MeasureTime frame
Abdominal pain. Timepoint: After intervention (one month after intervention). Method of measurement: Scoring patients based on a 0-10 Likert Scale with regard to improvements in symptoms (0=no improvement; 10= complete improvement).;Diarrhea. Timepoint: After intervention (one month after intervention). Method of measurement: Scoring patients based on a 0-10 Likert Scale with regard to improvements in symptoms (0=no improvement; 10= complete improvement).;Constipation. Timepoint: After intervention (one month after intervention). Method of measurement: Scoring patients based on a 0-10 Likert Scale with regard to improvements in symptoms (0=no improvement; 10= complete improvement).;Bloating. Timepoint: After intervention (one month after intervention). Method of measurement: Scoring patients based on a 0-10 Likert Scale with regard to improvements in symptoms (0=no improvement; 10= complete improvement).

Secondary

MeasureTime frame
Quality of life score. Timepoint: Before intervention, 2 weeks after intervention, 4 weeks after study being initiated, 2 weeks after termination of the intervention. Method of measurement: Completing 34-item questionnaire of life quality among IBS patients (IBS_QOL34) by the patient himself.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahdi Vazirian

Tehran University of Medical Sciences

Vazirian_m@tums.ac.ir+98 21 6412 1223

Outcome results

None listed

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