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

Phase 2

• Conditions: on-ulcer dyspepsia.; Dyspepsia

• Registration Number: IRCT138802061848N1
• Lead Sponsor: King Faisal University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 110

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

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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