Effect of Ajwain fruit extract in imroving irritable bowel syndrome (IBS) symptoms

Clinical trial of Ajwain fruit extract efficacy in management of symptoms of patients with Irritable Bowel Syndrome (IBS): A Case Series Study

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016030626938N1

Enrollment

Registered

2016-03-27

Start date

2016-12-21

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

Irritable Bowel Syndrome (IBS). Irritable colon

Interventions

Prescription of edible capsule containing hydroalcoholic extract of Ajwain fruit, based on 3 grams of the fruit, 3 times a day for 4 consecutive weeks.

Treatment - Drugs

Prescription of edible capsule containing hydroalcoholic extract of Ajwain fruit, based on 3 grams of the fruit, 3 times a day for 4 consecutive weeks

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: based on ROME II criteria and presence of abdominal pains, at least for 12 consecutive or inconsecutive weeks, which includes at least one of the 3 following criteria: 1- relief with defecation; 2- changes in frequency of stool; 3- changes in stool consistency . Exclusion criteria: concurrent disease (including chronic pulmonary disease, asthma, diabetes, thyroid disease or mental disease); pregnancy or breastfeeding and presence of sensitivity or allergic reactions to umbelliferae family; lack of patient cooperation in the treatment process.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Abdominal pain. Timepoint: Before intervention, 2 weeks after intervention, 4 weeks after intervention, 2 weeks after cessation of intervention and 4 weeks after cessation of intervention. Method of measurement: Severity of pain reported by the patient (Mild, Moderate, Severe) in questionnaire.;Severity of Nausea. Timepoint: Before intervention, 2 weeks after intervention, 4 weeks after intervention, 2 weeks after cessation of intervention and 4 weeks after cessation of intervention. Method of measurement: Severity of nausea reported by the patient (Mild, Moderate, Severe) in questionnaire.;Painful defecation. Timepoint: Before intervention, 2 weeks after intervention, 4 weeks after intervention, 2 weeks after cessation of intervention and 4 weeks after cessation of intervention. Method of measurement: Report of the patient (Yes/No) in questionnaire.;Presence of mucus in feces. Timepoint: Before intervention, 2 weeks after intervention, 4 weeks after intervention, 2 weeks after cessation of intervention and 4 weeks after cessation of intervention. Method of measurement: Report of the patient (Yes/No) in questionnaire.;Changes in feces consistency. Timepoint: Before intervention, 2 weeks after intervention, 4 weeks after intervention, 2 weeks after cessation of intervention and 4 weeks after cessation of intervention. Method of measurement: Report of the patient (Changed/Unchanged) in questionnaire.;Change in frequency of stool. Timepoint: Before intervention, 2 weeks after intervention, 4 weeks after intervention, 2 weeks after cessation of intervention and 4 weeks after cessation of intervention. Method of measurement: Report of frequency of defecation by the patient in questionnaire.	—

Measure

Time frame

Abdominal pain. Timepoint: Before intervention, 2 weeks after intervention, 4 weeks after intervention, 2 weeks after cessation of intervention and 4 weeks after cessation of intervention. Method of measurement: Severity of pain reported by the patient (Mild, Moderate, Severe) in questionnaire.;Severity of Nausea. Timepoint: Before intervention, 2 weeks after intervention, 4 weeks after intervention, 2 weeks after cessation of intervention and 4 weeks after cessation of intervention. Method of measurement: Severity of nausea reported by the patient (Mild, Moderate, Severe) in questionnaire.;Painful defecation. Timepoint: Before intervention, 2 weeks after intervention, 4 weeks after intervention, 2 weeks after cessation of intervention and 4 weeks after cessation of intervention. Method of measurement: Report of the patient (Yes/No) in questionnaire.;Presence of mucus in feces. Timepoint: Before intervention, 2 weeks after intervention, 4 weeks after intervention, 2 weeks after cessation of intervention and 4 weeks after cessation of intervention. Method of measurement: Report of the patient (Yes/No) in questionnaire.;Changes in feces consistency. Timepoint: Before intervention, 2 weeks after intervention, 4 weeks after intervention, 2 weeks after cessation of intervention and 4 weeks after cessation of intervention. Method of measurement: Report of the patient (Changed/Unchanged) in questionnaire.;Change in frequency of stool. Timepoint: Before intervention, 2 weeks after intervention, 4 weeks after intervention, 2 weeks after cessation of intervention and 4 weeks after cessation of intervention. Method of measurement: Report of frequency of defecation by the patient in questionnaire.

—

Secondary

Measure	Time frame
Pain with defecation. Timepoint: Before intervention, 2 weeks after intervention, 4 weeks after intervention, 2 weeks after cessation of intervention and 4 weeks after cessation of intervention. Method of measurement: Report of the patient (Mild, Moderate, Severe) in questionnaire.	—

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