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IRCT20200818048447N1 IRCT 2021-11-10 Yasouj University of Medical Sciences Evaluation of the Effectiveness of Hydrocortisone and Dexamethasone in the Management of Patients with Chronic Obstructive Pulmonary Disease Exacerbation. Evaluation of Effectiveness of Dexamethazone versus Hydrocortisone in Reducing Hospital Length, Oxidative Stress Factors and Inflammatory Mediators in Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Patients. 2021-03-05 anticipated 70 Complete https://irct.ir/trial/50867 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The 70 patients in the study are randomly divided into two groups of 35 with a one-to-one ratio by complete random generation method. For this purpose, first the list of patients' names is prepared and numbered from 1 to 70, then patients with odd numbers will be assigned to group one and patients with even numbers will be assigned to group two, Blinding description: Patients are explained that glucocorticoid drugs are standard treatment and there are no evidences to show one of them to be more effective than other in current condition. In this way, although patients do not know the name of their glucocorticoid drug, they will be aware of the general class of drugs and their side effects. Specifications and examinations will be recorded by a person who is blind to the groups and tests will be recorded by a person who is blind to the groups. 3 Chronic Obstructive Pulmonary Disease. Intervention 1: Intervention group: Intervention group 1 includes 35 patients with exacerbation of chronic obstructive pulmonary disease who receive 8 mg of dexamethasone injection,eight gram ampules of Iran Hormone Pharmaceutical Company, daily in addition to standard treatment. Intervention 2: Intervention group: Intervention group 2 includes 35 patients with exacerbation of chronic obstructive pulmonary disease who, in addition to standard daily treatment, receive 200 mg of injectable hydrocortisone, 100 mg / 2 ml hydrocortisone ampoule made by Alborz Drug Company of Iran , divided into four doses. Yes - There is a plan to make this available What will be shared: Individual data of participants will not be published. Published data can be shared after unidentifiable study subjects. When: Start access since December 2021 To whom: Health researchers as well as reputable pharmaceutical companies Conditions: Health researchers and pharmacy researchers will be able to request information for this study by providing identification documents. Where to obtain: Gmail: a.hoseyni80@gmail.com Phone: +989177046952 How to obtain: -Submitting a formal request via e-mail Provide provable proof of authentication Provide the possibility of contacting the relevant university or industrial center Verification by us This process takes a maximum of two weeks. Comments:
public Moslem Sedqattalab
Hormozpoor St. University of Medical Sciences
Yasuj Iran (Islamic Republic of) 7591741417 +98 74 3333 7231 a.hoseyni80@gmail.com Yasouj University of Medical Sciences scientific Moslem Sedaghattalab
Hormozpoor St. University of Medical Sciences
Yasuj Iran (Islamic Republic of) 7591741417 +98 74 3333 7231 a.Hoseyni80@gmail.com Yasouj University of Medical Sciences Iran (Islamic Republic of) Patients over 40 years Confirmed history (FEV1 / FVC <70%) of COPD or typical history (prolonged smoking and chronic sputum and cough) Exacerbations of the disease include increased cough, sputum, and shortness of breath 35 years no limit Both History of Asthma or Atopy Consumption Systemic Corticosteroids within the Last Month before Hospitalization Recent Myocardial Infarction Not Compensated Acute Heart Failure Diagnosis of Lobar Pneumonia on X-ray or CT scan of the Lungs J44.9 Chronic obstructive pulmonary disease, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Intervention group 1 includes 35 patients with exacerbation of chronic obstructive pulmonary disease who receive 8 mg of dexamethasone injection,eight gram ampules of Iran Hormone Pharmaceutical Company, daily in addition to standard treatment. Intervention group: Intervention group 2 includes 35 patients with exacerbation of chronic obstructive pulmonary disease who, in addition to standard daily treatment, receive 200 mg of injectable hydrocortisone, 100 mg / 2 ml hydrocortisone ampoule made by Alborz Drug Company of Iran , divided into four doses. Dyspnea. Timepoint: Daily till discharge. Method of measurement: Questionnaire. Patients score from 1 to 10 depending on the severity of dyspnea. Sputum volume. Timepoint: Daily. Method of measurement: Questionnaire. Patients score from 1 to 10 depending on the sputum volume. Couph. Timepoint: Daily. Method of measurement: Questionnaire. Patients score from 1 to 10 depending on the severity of couph. Arterial Oxygen Saturation. Timepoint: Daily. Method of measurement: Pulse Oxymeter Device. Duration of Hospitalization. Timepoint: Time of Discharge. Method of measurement: Counting the days of hospitalization. Sleep quality. Timepoint: Daily. Method of measurement: Patients score from 1 to 10 depending on their sleep quality. Peripheral white blood cell count. Timepoint: Day of hospitalization and day of discharge. Method of measurement: Auto-analyzer device in the form of thousand in microliters. Peak Expiratory Flow. Timepoint: Daily. Method of measurement: Peakflowmeter device. Edema. Timepoint: Daily. Method of measurement: Physician evaluation. Scoring from 1 to 4. Peripheral Blood Potassium. Timepoint: Day of hospitalization and day of discharge. Method of measurement: Electrolyte analyzer. Systemic Blood Pressure. Timepoint: Daily. Method of measurement: Mercury sphygmomanometer. General well being. Timepoint: Daily. Method of measurement: Questionnaire. Patients score from 1 to 10 depending on their general well being. Peripheral blood malone dialdehyde. Timepoint: Day of hospitalization and day of discharge. Method of measurement: Measurement with hydrochloric acid reagent. C Reactive Protein. Timepoint: Day of hospitalization and day of discharge. Method of measurement: Measurement by ELISA sandwich method. Yasouj University of Medical Sciences Approved 2021-03-05 Ethics committee of Yasuj University of Medical Sciences Motahary Av. University of Medical Sciences Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)