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IRCT20151227025726N31 IRCT 2022-06-18 Shahid Beheshti University of Medical Sciences Evaluation of the Effects of Noscapine on the Treatment of Patients with COVID-19 Evaluation of the Effects of Noscapine on the Treatment of Cough in COVID-19 Outpatients 2022-06-18 anticipated 100 Complete https://irct.ir/trial/63827 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method was used in this study. Twenty five blocks including 4 patients generated with online website (www.sealedenvelope.com/simple-randomiser/v1/lists). In each block, 2 patients will be assigned to noscapine group and 2 patients will be assigned to control group, Blinding description: Patients included to the study are randomized to two groups of drug and control (noscapine syrup and diphenhydramine syrup) by a randomizer (nurse) according to the randomization list taken from www.sealedenvelope.com. The researcher and data analyst only receive the data in code and were not aware of patients' assignments to the two groups. 3 COVID-19 pneumonia. Intervention 1: Intervention group: Patients receive Noscapine Syrup (Noscough®) 20 cc every 6 hours for 5 days. Intervention 2: Control group: Patients receive 7 cc diphenhydramine every 8 hours. Yes - There is a plan to make this available What will be shared: All potential data can be shared after blinding. When: Six months after publishing the results To whom: Researchers working in academic institutions Conditions: For research purposes and meta-analysis studies Where to obtain: Dr. farzaneh Dastan, Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran How to obtain: Official letter to the researchers through Email (fzh.dastan@gmail.com) Comments:
public Sahar Yousefian
Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran
Tehran Iran (Islamic Republic of) 19569-44413 +98 21 2712 2227 saahar26@yahoo.com Shahid Beheshti University of Medical Sciences scientific Farzaneh Dastan
Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences, Intersection of Niyayesh Highway, Valieasr St.
Tehran Iran (Islamic Republic of) 1991953381 +98 21 2712 2227 f_dastan@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) People over 18 years old Patient with cough and positive RT-PCR for COVID-19 and candidate for outpatient treatment The onset of illness equal to/less than 5 days 18 years no limit Both Pregnancy Breastfeeding Allergy to noscapine, morphine or any of the components of the formulation History of seizure Diarrhea Diabetes Consumption of warfarin, benzodiazepines, opioid agonists Getting antitussive drugs U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Intervention group: Patients receive Noscapine Syrup (Noscough®) 20 cc every 6 hours for 5 days. Control group: Patients receive 7 cc diphenhydramine every 8 hours. Time required to respond to treatment. Timepoint: Daily until discharge. Method of measurement: VAS scale. Time required to resolve cough. Timepoint: Daily until discharge. Method of measurement: Patient history. Intensity of cough. Timepoint: Daily until discharge. Method of measurement: CSS score. Quality of Life. Timepoint: Before the start of the study and at the end of the study. Method of measurement: CQLQ questionnaire. Blood oxygen level. Timepoint: Before the start of the study and at the end of the study. Method of measurement: Pulse oximeter. Shortness of breath. Timepoint: Before the start of the study and at the end of the study. Method of measurement: Patient history. Shahid Beheshti University of Medical Sciences Approved 2021-12-14 Ethics committees of School of Pharmacy, Nursing, and Midwifery; Shahid Beheshti University of Medic No. 2660, Vali-e Asr St., Niyayesh Junction, Tehran Tehran Tehran Iran (Islamic Republic of)