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IRCT20180611040053N2 IRCT 2020-02-23 Barij Essense Company Evaluation of the effect of a functional capsule on the complications of air pollution Evaluation of the effect of capsules containing natural products on serum level of biomarkers related to air pollution 2020-04-03 anticipated 90 Complete https://irct.ir/trial/41826 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The subjects in the study will be randomly divided into three groups. In this case first 5 triad blocks (letters A, B and C) will be made up for each six possible conditions (totally 30 blocks).These blocks will then be randomly selected and grouped together.So individuals will be allocated to the groups according each selected letter,, Blinding description: Individuals in all three groups will receive capsules of the same shape, size, and packaging. But on each package according to the type of capsules will be written; Model 1, Model 2 and Model 3 and the content of each model will be kept with the project supervisor so the presenters, study subjects and statistics expert will not be aware of the contents of the capsules. 3 medical effects of air pollution. Intervention 1: ّFirst intervention group: Administration of Weba air 500 milligram capsule containing processed saffron powder, patience yellow and cream produced by Barij Essence Company Two capsules will be consumed three times a week half hours before meal for 6 weeks. Intervention 2: Second intervention group: Administration of Weba air 250 milligram capsule containing processed saffron powder, patience yellow and cream produced by Barij Essence Company Two capsules will be consumed three times a week half hours before meal for 6 weeks. Intervention 3: Control group: Administration of placebo capsule produced by Barij Essence Company Two capsules are consumed three times a week half hours before a meal for 6 weeks. 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 According to ethic measures
public Leila Mohammad Thaghizadeh
Number 78, Marzdaran street
Tehran Iran (Islamic Republic of) 3795191916 +98 21 4426 7992 gpourtaghi@yahoo.com Barij Essense scientific Mohammad Ghasemi
Baqiyatallah University of Medical Sciences, Sheikh Bahaaee street, Molla Sadra street,
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8755 4484 mghmed@yahoo.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Signing informed consent working for more than 1 year in central regions in Tehran age between 21-60 years No significant renal or hepatic or pulmonary disease No hyperthyroidism No smoking or addiction to any drugs No cardiovascular diseases No consuming antioxidant medications or supplements No current fissures and hemorrhoids 21 years 60 years Male history of sensitivity to herbal medications Prevention Prevention Prevention ّFirst intervention group: Administration of Weba air 500 milligram capsule containing processed saffron powder, patience yellow and cream produced by Barij Essence Company Two capsules will be consumed three times a week half hours before meal for 6 weeks. Second intervention group: Administration of Weba air 250 milligram capsule containing processed saffron powder, patience yellow and cream produced by Barij Essence Company Two capsules will be consumed three times a week half hours before meal for 6 weeks. Control group: Administration of placebo capsule produced by Barij Essence Company Two capsules are consumed three times a week half hours before a meal for 6 weeks Serum levels of gluthation peroxidase, total antioxidant, CRP, fibrinogen, WBC and hematocrit. Timepoint: Two times, before the intervention and six weeks after beginning the intervention. Method of measurement: medical laboratory. Blood pressure. Timepoint: Two times, before the intervention and six weeks after beginning the intervention. Method of measurement: Mercury sphygmomanometer. Barij Essense Company Approved 2019-03-12 ٍEthics Committee of Baqiyatallah University of Medical Sciences Baqiyatallah University of Medical Sciences, Molla Sadra street, Sheikh Bahaee street, Shahid Nosrati avenue Tehran Tehran Iran (Islamic Republic of)