Efficacy of Nigella sativa seed oil in treatment of functional dyspepsia

Study on efficacy of honey based formulation of Nigella sativa seed oil in treatment of functional dyspepsia: A double blind randomized controlled clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201505031157N11

Enrollment

Registered

2015-06-03

Start date

2014-04-01

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

Diseases of the digestive system. Dyspepsia

Interventions

Intervention 1: Intervention group: 5 ml herbal drug (Mixture of Nigella sativa oil, honey and water in equaled proportion) administered 3 times a day orally for 8 week. Intervention 2: Placebo grou

Treatment - Drugs

Placebo

Intervention group: 5 ml herbal drug (Mixture of Nigella sativa oil, honey and water in equaled proportion) administered 3 times a day orally for 8 week

Placebo group: 5 ml placebo (Mixture of mineral oil, honey and water in equaled proportion) administered 3 times a day orally for 8 week

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients with clinical diagnosis of functional dyspepsia. Exclusion criteria: Patients with organic causes of dyspepsia; peptic ulcer disease; inflammatory bowel disease; pure gastroesophageal reflux disease; incomplete or discontinuation of treatment functional dyspepsia; patients with a history of taking H. pylori eradicating medication in previous 3 months; any gastrointestinal surgery; clinical history of any underlying disease such as coronary heart disease, diabetes mellitus, asthma, cancer, and chronic obstructive pulmonary disease; taking medication such as antihypertensive drugs, corticosteroids and supplements such as iron and calcium.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Functional dyspepsia. Timepoint: At starting of the study and after 8 weeks. Method of measurement: Functional dyspepsia was measured according to ROME III criteria and confirmed by upper gastrointestinal endoscopy.	—

Secondary

Measure	Time frame
Helicobacter pylori infection. Timepoint: At starting of the study and after 8 weeks. Method of measurement: Helicobacter pyloril infection was determined in laboratory by commercial urease test kit.;Health survey. Timepoint: At starting of the study and after 8 weeks. Method of measurement: Health survey was determined according to standared health survey short form (SF-36).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHasan Fallah Huseini

Institute of Medicinal Plants

huseini_fallah@yahoo.com+98 263476401020

Outcome results

None listed

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