A randomised controlled trial (pilot study) of the use of macerated garlic oil in patients with cystic fibrosis who have pulmonary infection with Pseudomonas aeruginosa - GAP pilot study
Phase 1
- Conditions
- Chronic pulmonary infection with Pseudomonas aeruginosa in patients with cystic fibrosis
- Registration Number
- EUCTR2005-000311-98-GB
- Lead Sponsor
- niversity of Nottingham
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
? Chronic pulmonary infection with P.aeruginosa
? Can produce sputum
? Are able to swallow the capsules
? Over 8 years
? Are not currently suffering from an acute pulmonary exacerbation, requiring oral or intravenous antibiotics
? Patient’s consent or parental consent with child’s assent
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
? Prolonged clotting or platelet count below 150 x 109/L at baseline
? Abnormal liver function
? Pregnant or lactating mothers
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method