Evaluation of the effects of curcumin-piperine in reducing Pseudomonas infection and improving clinical outcome in patients with cystic fibrosis

Phase 3

Conditions: cystic fibrosis.
Cystic fibrosis

Registration Number: IRCT20221229056976N1

Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 138

Inclusion Criteria

Cystic fibrosis patients who have been diagnosed based on clinical symptoms and sweat test.
5 years and above.
Have pulmonary and gastrointestinal problems.
able to perform the spirometry maneuver and have at least FEV1 greater than or equal to 30% based on the normal population based on age, gender and height.
The percentage of oxygen saturation based on pulse oximetry should be greater than or equal to 90% at room temperature.
be clinically stable.
Informed consent has been obtained from the patients.
Do not have heart, liver or kidney failure.
Do not have celiac disease.
No evidence of acute pulmonary exacerbation that requiring hospitalization in last past 4 weeks.
Do not have evidence of severe complications of pulmonary disease including severe hemoptysis or pneumothorax during the last 2 months.

Exclusion Criteria

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of clinical symptoms of patients. Timepoint: In each visit. Method of measurement: Based on Shwachman-Kulczycki Score.;Evaluation of pulmonary symptoms. Timepoint: Every 3 to 6 months. Method of measurement: Based on spirometry.;Evaluation of Pseudomonas pulmonary infection. Timepoint: Every 3 months. Method of measurement: With nasopharyngeal swab sample (sputum culture and colony count).;Weight. Timepoint: In each visit. Method of measurement: Weighing scale.;Height. Timepoint: In each visit. Method of measurement: Meter.;Body mass index (BMI). Timepoint: In each visit. Method of measurement: Body weight (kg) divided by the square of the body height(m).;Evaluation of patients' quality of life. Timepoint: Yearly. Method of measurement: Based on the quality of life questionnaire of cystic fibrosis patients.

Secondary Outcome Measures