Cystic Fibrosis. Other chronic obstructive pulmonary disease
Conditions
Interventions
Intervention 1: Intervention group: Nano-curcumin (Nano Sina Drug Company, Iran) was prepared as nanomicelle in the form of 70 milligrams of drops in 1 cc. To adjust the drug dose for different ages a
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
5 Years to 18 Years
Inclusion criteria
Inclusion criteria: One or more typical phenotypic features of CF and a minimum of an elevated sweat chloride concentration on two/more occasions or two mutations known to cause CF on separate alleles Age of 5-18 years Pulmonary and gastrointestinal involvement Ability to perform spirometry maneuvers and the minimum FEV1 of =30% compared to the same age, gender, and height in the normal population The percentage of oxygen saturation based on pulse oximetry of =90% at room temperature No cardiovascular, hepatic, and renal failure Absence of celiac disease and rheumatoid arthritis No acute pulmonary exacerbation requiring hospitalization within the past four weeks Absence of acute respiratory tract infection Informed consent for participation
Exclusion criteria
Exclusion criteria: The lack of adherence to the drug regimen Presence of drug intolerance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Inflammation at three levels: Systemic Inflammation, Pulmonary Inflammation, Gastrointestinal Inflammation. Timepoint: Before and after three months of trial. Method of measurement: 1) Systemic inflammation by assessing IL-8 as an inflammatory agent, IL-10 as an anti-inflammatory agent, and hsCRP level in the blood samples; 2) Pulmonary inflammation with the neutrophil count, and bacterial/viral culture on the nasopharyngeal swab; 3) Gastrointestinal inflammation with the calprotectin level in the fecal samples. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of pulmonary function. Timepoint: Before and after three months of trial. Method of measurement: Spirometer.;Quality of life. Timepoint: Before and after three months of trial. Method of measurement: Cystic Fibrosis Questionnaire(CFQ). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSaeedeh Talebi
Mashhad University of Medical Sciences
Outcome results
None listed