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Study for effectiveness of Nigella sativa (Black seed) in patients with dyspepsia

Comparative study of Nigella sativa and triple therapy in eradication of Helicobacter pylori in patients with non-ulcer dyspepsia

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT138802061848N1
Enrollment
110
Registered
2009-07-11
Start date
2007-03-15
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-ulcer dyspepsia. Dyspepsia

Interventions

Intervention 1: Triple therapy (clarithromycin+amoxicillin+omeprazole). Intervention 2: 1g of Nigella sativa seeds powder in capsule + 40mg omeprazole. Intervention 3: 2g of Nigella sativa seeds powde
Treatment - Drugs
Triple therapy (clarithromycin+amoxicillin+omeprazole)
1g of Nigella sativa seeds powder in capsule + 40mg omeprazole
2g of Nigella sativa seeds powder in capsule + 40mg omeprazole
3g of Nigella sativa seeds powder in capsule + 40mg omeprazole

Sponsors

King Faisal University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1) Patients complaining of dyspeptic symptoms 2) Patients with positive result for H. pylori infection confirmed by both histopathology and rapid urease test (CLO test) Exclusion criteria: 1) the endoscopy showed peptic ulcer, gastric cancer or other gastrointestinal bleeding 2) they had taken proton-pump inhibitors, bismuth or antibiotics in the last 4 weeks before endoscopy 3) pregnant or lactating 4) intolerant to therapeutic regimens

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Eradication of H. pylori. Timepoint: 4 weeks after the end of treatment. Method of measurement: Negative stool antigen by rapid monoclonal immunochromatographic method (ImmunoCard STAT! HpSA, Meridian Bioscience Europe).

Secondary

MeasureTime frame
Improvment in dyspeptic symptoms (epigastric pain and reflux symptoms). Timepoint: 4 weeks after end of teatment. Method of measurement: Questionnaire.

Countries

Saudi Arabia

Contacts

Public ContactDr Muhammad Akram Randhawa

King Faisal University

mrandaua@kfu.edu.sa00966-3-8577000 ext 2146

Outcome results

None listed

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