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IRCT20200101045976N1 IRCT 2020-02-06 Shahid Beheshti University of Medical Sciences Evaluating the Effect of Wet Cupping on quality of life in the Patients with Chronic Obstructive Pulmonary Disease COPD (Chronic Obstructive Pulmonary Disease) Evaluating the Effect of Wet Cupping on health-related quality of life in the Patients with Moderate Chronic Obstructive Pulmonary Disease 2020-02-17 anticipated 56 Complete https://irct.ir/trial/44866 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, after calculating the final sample size of the study, random chains are generated on the basis of simple random series using quadratic random blocks for both intervention and control groups. For the generated random chain, a corresponding code will be generated for each sequence. This code contains two letters of the alphabet and one number. Anonymous codes will be posted on the forms before the study begins. During the study, patients were divided into two groups according to the order of entry of patients and randomization sheets (merely including anonymous codes). Patients in the intervention group will receive wet cupping in addition to routine treatment. Patients in the control group will receive only routine treatment. 4 Chronic obstructive pulmonary disease. Intervention 1: Intervention group: Wet cupping( between the two scapulas ) [ Wet-cupping will be performed by a physician on one of the days of 17, 19 and 21 lunar months. Intervention will done only once. Wet-cupping treatment procedure will last about 10 min and will be conducted in three steps. ) + Standard treatment [ Symbicort spray 320 mcg one puff every 12 hours(Symbicort contains a combination of budesonide 320 mcg and formoterol 9mcg ), manufacturing Company: AstraZeneca Duration of use:One Month and Atrovent spray one puff every 8 hours( Atrovent Inhaler 20 mcg/dose ) manufacturing Company: BOEHRINGER INGELHEIM Duration of use:One Month or Pulmicort spray 200 one puff every 12 hours( Each metered dose contains 200 micrograms of budesonide ) manufacturing Company: AstraZeneca Duration of use:One Month and Foradil spray one puff every 12 hours ( each capsule contains 12 micrograms formoterol ) manufacturing Company: Novartis duration of use:one month and Thiotropium spray one puff every morning ( each capsule contains: Thiotropium 18 mcg ) manufacturing Company: BOEHRINGER INGELHEIM duration of use:one month ]. Intervention 2: Control group: Standard treatment [ Symbicort spray 320 mcg one puff every 12 hours(Symbicort contains a combination of budesonide 320 mcg and formoterol 9mcg ), manufacturing Company: AstraZeneca Duration of use:One Month and Atrovent spray one puff every 8 hours( Atrovent Inhaler 20 mcg/dose ) manufacturing Company: BOEHRINGER INGELHEIM Duration of use:One Month or Pulmicort spray 200 one puff every 12 hours( Each metered dose contains 200 micrograms of budesonide ) manufacturing Company: AstraZeneca Duration of use:One Month and Foradil spray one puff every 12 hours ( each capsule contains 12 micrograms formoterol ) manufacturing Company: Novartis duration of use:one month and Thiotropium spray one puff every morning ( each capsule contains: Thiotropium 18 mcg ) manufacturing Company: BOEHRINGER INGELHEIM duration of use:one month ]. Yes - There is a plan to make this available What will be shared: Publishing results in form of a PhD thesis and an article indexing in ISI When: after PhD thesis defence To whom: Public Conditions: for research reasons Where to obtain: Shahid Beheshti University of Medical Sciences How to obtain: approving by responsible officer Comments:
public Roya Baniamerian
No.8 Shams Alley, Vali-e-Asr Street
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 3521 rbaniamerian@yahoo.com Shahid Beheshti University of Medical Sciences scientific Roya Baniamerian
No.8 Shams Alley, Vali-e-Asr Street
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 3521 dr-baniamerian@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with moderate COPD diagnosed by lung specialty From 30 years old to 60 years old Individual willingness and satisfaction to enter the study stable clinical condition The same type of medication used 30 years 60 years Both Patients with a history of anemia Patients with a history of coagulopathy History of treatment with wet cupping in the last 1 month Lactation Pregnancy Patients with severe COPD and need hospitalization Patients with underlying diseases such Cystic fibrosis, bronchopulmonary dysplasia, heart failure, bronchotracheomalacia, bronchiectasis, pulmonary embolism, and sarcoidosis Patients taking drugs such as aspirin, beta-blocker and non-steroidal anti-inflammatory drugs (NSAIDs) J44.9 Chronic obstructive pulmonary disease, unspecified Treatment - Devices Treatment - Other Intervention group: Wet cupping( between the two scapulas ) [ Wet-cupping will be performed by a physician on one of the days of 17, 19 and 21 lunar months. Intervention will done only once. Wet-cupping treatment procedure will last about 10 min and will be conducted in three steps. ) + Standard treatment [ Symbicort spray 320 mcg one puff every 12 hours(Symbicort contains a combination of budesonide 320 mcg and formoterol 9mcg ), manufacturing Company: AstraZeneca Duration of use:One Month and Atrovent spray one puff every 8 hours( Atrovent Inhaler 20 mcg/dose ) manufacturing Company: BOEHRINGER INGELHEIM Duration of use:One Month or Pulmicort spray 200 one puff every 12 hours( Each metered dose contains 200 micrograms of budesonide ) manufacturing Company: AstraZeneca Duration of use:One Month and Foradil spray one puff every 12 hours ( each capsule contains 12 micrograms formoterol ) manufacturing Company: Novartis duration of use:one month and Thiotropium spray one puff every morning ( each capsule contains: Thiotropium 18 mcg ) manufacturing Company: BOEHRINGER INGELHEIM duration of use:one month ] Control group: Standard treatment [ Symbicort spray 320 mcg one puff every 12 hours(Symbicort contains a combination of budesonide 320 mcg and formoterol 9mcg ), manufacturing Company: AstraZeneca Duration of use:One Month and Atrovent spray one puff every 8 hours( Atrovent Inhaler 20 mcg/dose ) manufacturing Company: BOEHRINGER INGELHEIM Duration of use:One Month or Pulmicort spray 200 one puff every 12 hours( Each metered dose contains 200 micrograms of budesonide ) manufacturing Company: AstraZeneca Duration of use:One Month and Foradil spray one puff every 12 hours ( each capsule contains 12 micrograms formoterol ) manufacturing Company: Novartis duration of use:one month and Thiotropium spray one puff every morning ( each capsule contains: Thiotropium 18 mcg ) manufacturing Company: BOEHRINGER INGELHEIM duration of use:one month ] Evaluation of quality of life of patients. Timepoint: The time of study inclusion and one and three weeks later. Method of measurement: COPD Assessment Test (CAT) Questionnair. Shahid Beheshti University of Medical Sciences Approved 2019-12-31 Ethics Committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)