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IRCT20170827035935N2 IRCT 2018-02-10 Vice chancellor for research of Mazandaran University of Medical Science The effect of magnesium in controlling asthma A clinical trial of the study of the effect of magnesium supplementation on asthma 2017-03-20 anticipated 40 Complete https://irct.ir/trial/27011 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method in this randomized study is easy randomization. Patients will be placed in two groups of control (non-supplement magnesium) and the case group (magnesium supplements recipient) using a randomized table, Blinding description: Patients will not be aware of any kind of medication (magnesium supplement or placebo), and the investigator will not know whether each patient receives medication or placebo. The placebo is completely white in the form of pills. It is a homogeneous with complementary magnesium supplement that is provided by the Faculty of Pharmacy of Mazandaran University of Medical Sciences. Magnesium supplement is purchased in the number of intervention group and code A is written by the clinical pharmacist on the pill. The placebo is provided for the control group and code B is written by the pharmacist of the study on the container. The patient and researcher responsible for distributing the medicine are not aware of the type of medicine and their distribution. 2-3 Asthma. Intervention 1: Intervention group: Magnesium Supplement with Brand Magne B6, product of Sanofi Aventis Pharmaceutical Factory, containing 470 mg of lactate magnesium, equivalent to 48 mg of magnesium, begins twice a day and will be used as a preservative for up to 8 weeks on a daily basis. Intervention 2: Control group: The Placebo made by pharmaceutical faculty of the Mazandaran University of Medical Sciences will be used twice a day and as a preservative for up to 8 weeks on a daily basis. 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 No more information
public Dr. Ali Sharif Pour
Internal Medicine Departmnt, Imam Khomeini Hospital
Sari Iran (Islamic Republic of) 4815733971 +98 11 3448 4864 hamed.jafarpour7@gmail.com Mazandaran University Of Medical Science scientific Babak Mahmoodi
Payambar Azam Campus, Km 17 on Farah Abad road
Sari Iran (Islamic Republic of) 4815733971 +98 11 3448 4864 hamed.jafarpour7@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients with asthma 18 years 60 years Both Use of oral corticosteroids Use Diuretics Renal failure Congestive heart failure Use of magnesium supplement in the past quarter History of using cigarettes Pregnancy The decision to have a pregnancy J45.9,J46 Asthma, unspecified, Acute severe asthma Treatment - Drugs Placebo Intervention group: Magnesium Supplement with Brand Magne B6, product of Sanofi Aventis Pharmaceutical Factory, containing 470 mg of lactate magnesium, equivalent to 48 mg of magnesium, begins twice a day and will be used as a preservative for up to 8 weeks on a daily basis. Control group: The Placebo made by pharmaceutical faculty of the Mazandaran University of Medical Sciences will be used twice a day and as a preservative for up to 8 weeks on a daily basis. Severity of asthma. Timepoint: At the beginning of the study (before the intervention) and at weeks 4, 8 and 12 after the intervention. Method of measurement: PEFR measurements by peak flow meter. FEV1/FVC. Timepoint: Before and immediately after the intervention. Method of measurement: Spirometry. The number of asthma attacks. Timepoint: At the beginning of the study (before the intervention) and at weeks 4, 8 and 12 after the intervention. Method of measurement: Ask the patient. ACT-Score. Timepoint: At the beginning of the study (before the intervention) and at weeks 4, 8 and 12 after the intervention. Method of measurement: ACT questionnaire. FEV1. Timepoint: Before and immediately after the intervention. Method of measurement: Spirometry. FVC. Timepoint: Before and immediately after the intervention. Method of measurement: Spirometry. -. Timepoint: -. Method of measurement: -. Vice chancellor for research of Mazandaran University of Medical Science Approved 2017-08-19 Ethics committee of Mazandaran University of Medical Sciences Deputy of research and technology, Moalem Sq Sari Mazandaran Iran (Islamic Republic of)