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IRCT20110109005579N2 IRCT 2019-09-17 Ardabil University of Medical Sciences Saffron effect in Chronic Obstructive Pulmonary Disease (COPD). The effect of saffron on pulmonary function and serum levels of Interleukin-6 and Tumor Necrosis Factor-α in patients with Chronic Obstructive Pulmonary Disease 2019-09-23 anticipated 90 Complete https://irct.ir/trial/41998 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants will be recruited from patients that referred to the pulmonary clinic of Ardabil Imam Khomeini Hospital. Patients will be evaluated and in the case of satisfying inclusion criteria, they will be referred to the clinics nurse. A per-defined list will be utilized for subject's enrollment. The list consists two groups of trial and placebo (each 45 subjects) which was prepared by Excel using Randbetween function. Patients will be allocated in two groups by simple randomization. 45 "A" labeled and 45 "B" labeled sealed envelopes will be used by nurse to provide medicine and placebo to patients, Blinding description: Participants, patient care student and outcome evaluator, person responsible for data collection don't aware from pocket contents. 3 Chronic obstructive pulmonary disease. Intervention 1: "Intervention group:" Patients with Chronic Obstructive Pulmonary Disease will be receive standard treatments based on Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guideline and 30mg/day Saffron Tablets for 12 weeks (Produced by: BuAli Institute of Pharmaceutical Sciences, Pharmaceutical Product Development Center, Sina Pharmaceutical Company, Reg. No. 48674). Intervention 2: "Control group:" Patients with Chronic Obstructive Pulmonary Disease will be receive standard treatments based on Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guideline and 30mg/day Saffron Placebo Tablets for 12 weeks (Produced by: BuAli Institute of Pharmaceutical Sciences, Pharmaceutical Product Development Center, Sina Pharmaceutical Company, Reg. No. 48674). Yes - There is a plan to make this available What will be shared: Data of outcome can be shared. When: Result access after paper publication To whom: Academic researcher Conditions: As a scientific paper Where to obtain: Corresponding author, Hassan Ghobadi How to obtain: via email address: h.ghobadi@arums.ac.ir Comments:
public Hassan Ghobadi
Shhid Noe-Aghdam Street
Ardabil Iran (Islamic Republic of) 5619647531 009833251410 h.ghobadi@arums.ac.ir Ardabil University of Medical Sciences scientific Hassan Ghobadi
Ardabil, Emam Khomeini Hospital, Noei-Aghdam Street
Ardabil Iran (Islamic Republic of) 56196-47531 +98 45 3325 1401 h.ghobadi@arums.ac.ir Ardabil University of Medical Sciences Iran (Islamic Republic of) Chronic Obstructive Pulmonary Disease Age between 40-85 Clinically stable disease in previous 8 weeks Acceptance of study design by patients 40 years 85 years Male Active infectious disease Bronchiectasis Chronic inflammatory diseases Active liver and kidney diseases Cancer patients Cardiac disease (myocardial infarction and unstable angina in previous 6 months) Sensitivity to saffron J44.8 Other specified Chronic Obstructive Pulmonary Disease Treatment - Drugs Treatment - Drugs "Intervention group:" Patients with Chronic Obstructive Pulmonary Disease will be receive standard treatments based on Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guideline and 30mg/day Saffron Tablets for 12 weeks (Produced by: BuAli Institute of Pharmaceutical Sciences, Pharmaceutical Product Development Center, Sina Pharmaceutical Company, Reg. No. 48674). "Control group:" Patients with Chronic Obstructive Pulmonary Disease will be receive standard treatments based on Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guideline and 30mg/day Saffron Placebo Tablets for 12 weeks (Produced by: BuAli Institute of Pharmaceutical Sciences, Pharmaceutical Product Development Center, Sina Pharmaceutical Company, Reg. No. 48674). Serum Level of IL-6. Timepoint: Beginning of study and 12 weeks after intervention. Method of measurement: Laboratory. Tumor Necrosis factor alpha (TNF-α). Timepoint: Beginning of study and 12 weeks after intervention. Method of measurement: Laboratory. Pulmonary Function Test. Timepoint: beginning of study and 12 weeks after intervention. Method of measurement: Laboratory (Spirometry Device). Total oxidant status (TOS). Timepoint: Beginning of study and 12 weeks after intervention. Method of measurement: Laboratory. Total antioxidant capacity (TAC). Timepoint: Beginning of study and 12 weeks after intervention. Method of measurement: Laboratory. Nuclear factor kappa B (NF-κB). Timepoint: Beginning of study and 12 weeks after intervention. Method of measurement: Laboratory. COPD Assessment Test (CAT). Timepoint: Beginning of study and 12 weeks after intervention. Method of measurement: CAT Questionnaire, accessible at: https://www.catestonline.org. Dyspnea scale: Modified Medical Research Council (MMRC) questionnaire. Timepoint: Beginning of study and 12 weeks after intervention. Method of measurement: Modified Medical Research Council (MMRC) questionnaire. Exercise scale: Six Minute Walk Distance (6MWD). Timepoint: Beginning of study and 12 weeks after intervention. Method of measurement: Six Minute Walk Distance (6MWD) questionnaire. Oxygen saturation of arterial blood. Timepoint: Beginning of study and 12 weeks after intervention. Method of measurement: Pulse oximetry. Saffron side effects. Timepoint: 4 weeks and 12 weeks after intervention. Method of measurement: Record of adverse effect in checklist. Ardabil University of Medical Sciences Approved 2019-03-03 Ardabil University of Medical Sciences Ethic Committe Internal Medicine Department, Emam Khomeini Hospital, Shahid Noe-Aghdam Street, Ardabil Ardabil Ardabil Iran (Islamic Republic of) Approved 2019-11-03 Ardabil University of Medical Sciences Ethic Committe Internal Medicine Department, Emam Khomeini Hospital, Shahid Noe-Aghdam Street, Ardabil Ardabil Ardabil Iran (Islamic Republic of)