The effect of black seed on irritable bowel syndrome

Evaluation of total black seed (nigella sativa) extract efficacy in patients with irritable bowel syndrome

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20160709028845N1

Enrollment

160

Registered

2022-03-07

Start date

2022-02-20

Completion date

Unknown

Last updated

2022-04-04

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

Conditions

irritable bowel syndrome. Irritable bowel syndrome

Interventions

Intervention 1: Intervention group: Patients with irritable bowel syndrome are taking 500 mg of black seed extract capsules every 12 hours during the study. Extraction and preparation of capsules is p

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Diagnosis of Irritable Bowel Syndrome Based on Roma IV Diagnosis Criteria. People aged 18 to 50 years and if they are over 50 years old, colonoscopy should be screened to make sure there are no other diseases and malignancies. No malignancies (carcinoid and colorectal tumors), celiac disease, diverticulitis, gastrointestinal infections, hyper and hypothyroidism, lactose intolerance, IBD, and ischemic colitis No previous use of drugs, calcium channel blockers and antidepressants

Exclusion criteria

Exclusion criteria: Having a history of allergy to black seed compounds Dissatisfaction with attending the study Pregnancy

Design outcomes

Primary

Measure	Time frame
Severity of abdominal pain,. Timepoint: every two weeks for three consecutive months. Method of measurement: Irritable bowel syndrome severity questionnaire using Visual Analogue Scale.;Severity of abdominal distension. Timepoint: every two weeks for three consecutive months. Method of measurement: Irritable bowel syndrome severity questionnaire using Visual Analogue Scale.;Satisfaction with defecation habit. Timepoint: every two weeks for three consecutive months. Method of measurement: Irritable bowel syndrome severity questionnaire using Visual Analogue Scale.	—

Measure

Time frame

Severity of abdominal pain,. Timepoint: every two weeks for three consecutive months. Method of measurement: Irritable bowel syndrome severity questionnaire using Visual Analogue Scale.;Severity of abdominal distension. Timepoint: every two weeks for three consecutive months. Method of measurement: Irritable bowel syndrome severity questionnaire using Visual Analogue Scale.;Satisfaction with defecation habit. Timepoint: every two weeks for three consecutive months. Method of measurement: Irritable bowel syndrome severity questionnaire using Visual Analogue Scale.

—

Secondary

Measure	Time frame
Quality of life in patients with irritable bowel syndrome. Timepoint: At the beginning of the study and every month for three consecutive months. Method of measurement: world health organization quality of life questioner (brief form).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNima Bakhtiarri

Ahvaz University of Medical Sciences

bakhtiari.n@ajums.ac.ir+98 61 3392 9324

Outcome results

None listed

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