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IRCT20200324046851N2 IRCT 2022-02-22 Tabriz University of Medical Sciences Evaluation of gene expression, methylation and secretory level of cytokines and inflammatory chemokines in COPD patients receiving nanocurcumin supplementation compared with patients receiving placebo Evaluation of gene expression, methylation and secretory level of cytokines and inflammatory chemokines in COPD patients receiving nanocurcumin supplementation compared with patients receiving placebo 2022-04-03 anticipated 30 Complete https://irct.ir/trial/61671 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: Participants and the lead researcher were unaware of medication or placebo in different patients. 3 Chronic Obstructive Pulmonary Disease (COPD). Intervention 1: Intervention group: Nanocurcumin recipient.From 30 patients with COPD receiving 80 mg of nanocurcumin daily for 90 days before and after the intervention, 10 cc of blood containing anticoagulant will be taken to isolate PBMC. Intervention 2: Control group: Placebo receiving group. From 30 patients with COPD receiving pelacebo daily for 90 days before and after the intervention, 10 cc of blood containing anticoagulant will be taken to isolate PBMC. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is it is not known at the moment
public Ali Hazrati
Marzdaran
Tabriz Iran (Islamic Republic of) 5158963161 +98 41 3638 7391 alihazrati833@gmail.com Tabriz University of Medical Sciences scientific Ali Hazrati
Golgasht
Tabriz Iran (Islamic Republic of) 5158963161 +98 41 3638 7391 alihazrati833@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Diagnosed with COPD with stage B, C, or D according to GOLD 2019.. Age between 40-75 years old. Both genders. Smoker or less than 6 months of smoking cessation time no limit no limit Both Asthma and other pulmonary-related diseases and injuries (including lung tuberculosis, restrictive lung disease, idiopathic pulmonary fibrosis, or lung cancer). Acute and/or active infection. Cancer. Patients with complex cardiovascular diseases (including valvular heart disease, cardiomyopathy, arrhythmia, congenital heart disease, hypertrophy syndrome). Liver and kidney failure. Pregnancy. Patients with life expectancy less than 6 months due to concomitant illness. Under immunosuppressive treatment within 8 weeks of the first screening visit J44 Other chronic obstructive pulmonary disease Treatment - Drugs Placebo Intervention group: Nanocurcumin recipient.From 30 patients with COPD receiving 80 mg of nanocurcumin daily for 90 days before and after the intervention, 10 cc of blood containing anticoagulant will be taken to isolate PBMC Control group: Placebo receiving group. From 30 patients with COPD receiving pelacebo daily for 90 days before and after the intervention, 10 cc of blood containing anticoagulant will be taken to isolate PBMC IL-1. Timepoint: Day 0 and day 90 after receiving the drug. Method of measurement: ELISA and PCR. CCL2. Timepoint: Day 0 and day 90 after receiving the drug. Method of measurement: ELISA and PCR. CXCL8. Timepoint: Day 0 and day 90 after receiving the drug. Method of measurement: ELISA and PCR. IL-6. Timepoint: Day 0 and day 90 after receiving the drug. Method of measurement: ELISA and PCR. IL-18. Timepoint: Day 0 and day 90 after receiving the drug. Method of measurement: ELISA and PCR. IFN-γ. Timepoint: Day 0 and day 90 after receiving the drug. Method of measurement: ELISA and PCR. TNF-α. Timepoint: Day 0 and day 90 after receiving the drug. Method of measurement: ELISA and PCR. Tabriz University of Medical Sciences Approved 2021-11-14 Academic Committee on Research Ethics (Studies in Human Subjects) tabriz University of Medical Scien Golgasht St., Tabriz University of Medical Sciences Tabriz East Azarbaijan Iran (Islamic Republic of)