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IRCT20200705048018N1 IRCT 2020-07-10 Mashhad University of Medical Sciences Evaluation of using curcumin as a nutritional strategy on clinical finding and inflammatory markers in children with cystic fibrosis The Effects of curcumin as a Nutritional Strategy on Clinical and Inflammatory Factors in Children with Cystic Fibrosis 2020-05-21 anticipated 60 Complete https://irct.ir/trial/49437 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: All known cystic fibrosis patients referred to the clinic were included in the study based on the inclusion criteria. After that, spirometry was down and patients were divided into two groups using FEV1with 40% cutoff range: Severe lung disease (FEV1 lower than 40%) and Non severe lung disease(FEV1 higher than 40%).(Stratified randomization based on disease severity). Following that, simple random sampling method was used to select the patients from each groups and each stages divided in to two groups of case and control by using a table of random numbers , Blinding description: The curcumin and placebo glasses were labeled A and B, respectively and made available to the patients through the double-blind design. 1 Cystic Fibrosis. 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 and considering that the maximum acceptable dose based with the most significant impact and minimum side-effects was 80 milligrams, the required amount was obtained for each subject based on the ratio of the body surface area of the patients. The curcumin and placebo glasses were labeled A and B, respectively and made available to the patients through the double-blind design. The duration of the treatment period was three months. Intervention 2: Control group:The placebo was made of polysorbate with the same color and taste. Placebo glasses were labeled A and B, respectively and made available to the patients through the double-blind design. The duration of the treatment period was three months. Yes - There is a plan to make this available What will be shared: All data can be shared When: since 1400 years To whom: Academic and scientific institutions Conditions: I haven't decided on that yet Where to obtain: Saeedeh Talebi How to obtain: Send an email to the author responsible for the project Comments:
public Saeedeh Talebi
No. 2.12, Taleghani 7., Ahmad Abad Street., Mashhad Town
Mashhad Iran (Islamic Republic of) 9176756436 +98 51 3842 0718 talebis@mums.ac.ir Mashhad University of Medical Sciences scientific Saeedeh Talebi
No. 2.12, Taleghani 7., Ahmad Abad Street., Mashhad Town
Mashhad Iran (Islamic Republic of) 9176756436 +98 51 3842 0718 talebis961@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 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 5 years 18 years Both The lack of adherence to the drug regimen Presence of drug intolerance J44 Other chronic obstructive pulmonary disease Treatment - Drugs Treatment - Drugs 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 and considering that the maximum acceptable dose based with the most significant impact and minimum side-effects was 80 milligrams, the required amount was obtained for each subject based on the ratio of the body surface area of the patients. The curcumin and placebo glasses were labeled A and B, respectively and made available to the patients through the double-blind design. The duration of the treatment period was three months. Control group:The placebo was made of polysorbate with the same color and taste. Placebo glasses were labeled A and B, respectively and made available to the patients through the double-blind design. The duration of the treatment period was three months. 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. 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). Mashhad University of Medical Sciences Approved 2019-07-06 Ethics Committee of Research in Mashhad University of Medical Sciences Ferdowsi Blvd., Mashhad University of Medical Sciencess Mashhad Razavi Khorasan Iran (Islamic Republic of)