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IRCT20211031052922N1 IRCT 2021-12-01 Esfahan University of Medical Sciences Effect of Medroxy progesteron in Chronic Obstructive Pulmonary Disease (COPD) exacerbation بیماری انسدادی مزمن ریوی یاChronic Obstructive Pulmonary Disease(COPD) /تهویه غیر تهاجمی یاNon Invasive Ventilation (NIV) Evaluation of the effectiveness of medroxyprogesterone on blood gases and short term hospital outcomes in patients with Chronic Obstructive Pulmonary Disease (COPD) exacerbation who received Non Invasive Ventilation (NIV) 2021-08-23 anticipated 70 Complete https://irct.ir/trial/59681 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Single, Purpose: Treatment, Randomization description: Patients were recruited based on the mentioned criteria and 70 patients are selected.They are randomly divided into two groups based on permuted block randomization by using Random Allocation software that each group(case and control)contain of 35 participant.For assurance of participant are divided equally to case and control in consecutive interval,we use 10 blocked randomization that each of them contain 7 participant.Odd blocks are interventional group and even blocks are control group, Blinding description: In this study participants and doctors are blind.participant after signing informed consent,accept that may recieve drug or placebo.Doctors dont know which patient may recieve medroxy progesteron or placebo.Doctors after initial visit of COPD exacerbation patients who need Non Invasive Ventilation(NIV),report the patients to study supervisior(pulmonary fellowship).Study supervisior is checking inclusion and exclusion criteria and recieved informed consent.After randomazation by study supervisor ,drugs or placebo are taken to nurse of patients (who are blind)for daily prescription.Also nurse dont know that the patient recieve placebo or drug.Study forms are completed by doctors daily.After 5th days,supervisior collect forms and drug or placebo prescription discontinue. 3 Chronic Obstructive Pulmonary Disease(COPD) Exacerbation. Intervention 1: Intervention group: prescription medroxy pogesteron acetate 15mg per 6 hour until 5days to COPD (Chronic Obstructive Pulmonary Disease)exacerbation patients who needs Non InvasiveVentilation(NIV) .Medroxy progesteron tablets 5 mg are produced by Aboreyhan company.We prescript 3tablets of medroxy progesteron 5mg(15mg) every 6 hour. Intervention 2: Control group: prescription placebo that similar to Medroxy progesteron per 6 hour to COPD exacerbation patients(every 6hour precript 3 tablet of placebo).We will produce placebo with help of faculty of pharmacy of Isfahan medical university. Yes - There is a plan to make this available What will be shared: We decide to share our questionare forms (after unidentifiable) and SPSS files of primary and secondary variables and data analysis of our study by other researchers When: 6 month after article is published To whom: Reshearcher in medical and pharmaceutical field that work in university or pharmacy company Conditions: After we study their study proposal,usage of our data will be possible.Analysis of ourdata according to their study will be possible.if usage our data help them to result in an article,we expect our name mention as colleague Where to obtain: Email to me minanickpour@yahoo.com How to obtain: First we must study their research proposal,if our data help them,immediately we give our datas and SPSS files and other files if needed Comments:
public Mina Nickpour
Khorshid hospital, Ostandari Ave, Esfahan
Esfahan Iran (Islamic Republic of) 8145831451 +98 31 3263 8279 minanickpour@yahoo.com Esfahan University of Medical Sciences scientific Mina Nickpour
Khorshid hospital, Ostandari Ave, Esfahan
Esfahan Iran (Islamic Republic of) 8174675731 +98 31 3263 8279 minanickpour@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Chronic Obstructive Pulmonary Disease (COPD) exacerbation patients who has one of this criteria(dyspnea, increased sputum volume, and a change in the nature of sputum) COPD exacerbation patient who needs Non Invasive Ventilation (NIV) Age between 30-80 Signing the written informed consent 30 years 80 years Both Requiring mechanical ventilation by the time of admission Having a current or history of thromboembolic diseases like Pulmonary Thrombosis Embolie (PTE), active thrombophelebitis, Deep Vein Thrombosis (DVT) History of cerebrovascular disease, history of myocardial infarction (MI) and stroke Unexplained vaginal bleeding Hepatic diseases Pregnancy History of breast cancer or any estrogen or progesterone dependent tumors History of allergy to hormonal drugs containing progesterone Stable and frequent vomiting Decreased level of consciousness Deformity or trauma in face J44.1 Chronic obstructive pulmonary disease with acute exacerbation, unspecified Treatment - Drugs Placebo Intervention group: prescription medroxy pogesteron acetate 15mg per 6 hour until 5days to COPD (Chronic Obstructive Pulmonary Disease)exacerbation patients who needs Non InvasiveVentilation(NIV) .Medroxy progesteron tablets 5 mg are produced by Aboreyhan company.We prescript 3tablets of medroxy progesteron 5mg(15mg) every 6 hour. Control group: prescription placebo that similar to Medroxy progesteron per 6 hour to COPD exacerbation patients(every 6hour precript 3 tablet of placebo).We will produce placebo with help of faculty of pharmacy of Isfahan medical university. ICU admission. Timepoint: Daye1;3;5. Method of measurement: doctors reports. Intubation. Timepoint: Days1,3,5. Method of measurement: Doctors reports. Venous blood gase. Timepoint: Days1,3,5. Method of measurement: ABG analysor. O2saturation. Timepoint: Days1,3,5. Method of measurement: Pulse oximetery. Hospitalization days. Timepoint: In day 5 and days of discharge. Method of measurement: Days of hospitalization. Dyspnea score. Timepoint: Days 1,3,5. Method of measurement: Borg scale. Non Invasive Ventilation(NIV) hours/day usage. Timepoint: Days 1,3,5. Method of measurement: Based on doctors reports. Esfahan University of Medical Sciences Approved 2020-11-20 Ethics committee of Isfahan University of Medical science Isfahan Medical Univesity , Hezarjarib Ave, Esfahan Esfahan Isfehan Iran (Islamic Republic of)