The Effect of Anise-oil capsules on IBS Treatment

Randomised Clinical Trial: Enteric-coated Anise-oil capsules vs. placebo & active controlled in Irritable Bowel Syndrome – A 4 week double-blind study with 2 weeks follow-up

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201205069651N1

Enrollment

120

Registered

2015-02-03

Start date

2012-08-22

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

Non- Response IBS Patients. Irritable bowel syndrome

Interventions

Intervention 1: Intervention Group: Anise-oil EC Capsule,One Cap(187mg)/day for 4 weeks. Paients will be Followed at Baseline, 4 and 6 Weeks after Starting Intervention. Intervention 2: Placebo Group:

Treatment - Drugs

Placebo

Intervention Group: Anise-oil EC Capsule,One Cap(187mg)/day for 4 weeks. Paients will be Followed at Baseline, 4 and 6 Weeks after Starting Intervention.

Placebo Group: One Placebo Capsule/Day for 4 Weeks. Paients Will be Followed at Baseline, 4 and 6 Weeks after Starting Intervention.

Eligibility

Sex/Gender

All

Age

20 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Meeting the Rome III Modular Questionnaire; Patients with 50 years were required to have a colonoscopy performed within the previous 5 years; Patients under the age of 50 years were required to have a sigmoidoscopy performed Exclusion criteria: Unable or unwilling patients to use an acceptable method of birth control; Pregnant or nursing females; Previous gastrointestinal or abdominal surgery (except for common causes unrelated to IBS); Organic disorder of the large or small bowel (e.g. ulcerative colitis, Crohn’s disease); Mechanical obstruction; Unexplained significant weight loss or rectal bleeding; Diagnosis of any medical condition associated with constipation (other than IBS); Cancer; Abnormal laboratory tests; Abuse of alcohol or drugs

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Quality of Life (QOL), pain, flatulence, diarrhea, constipation, reflux, headache and tiredness. Timepoint: Baseline. Method of measurement: (IBS-QOL) questionnaire and 10-point visual scale ranging.	—

Secondary

Measure	Time frame
Change in Quality of Life (QOL), pain, flatulence, diarrhea, constipation, reflux, headache and tiredness at end of treatment. Timepoint: End of Follow Up(6 weeks after staring intervention). Method of measurement: (IBS-QOL) questionnaire and 10-point visual scale ranging.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Maryam Mosaffa-Jahromi

Health Policy Research Center

mosaffam@sums.ac.ir+98 71 3230 9615

Outcome results

None listed

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