]>
IRCT20180103038199N3 IRCT 2020-08-30 Mashhad University of Medical Sciences effects of three products containing Noscapine on COVID-19 Evaluation and comparison of the effectiveness of three herbal products containing Noscapine (Opiucough, Noscough and Noscatem) on clinical symptoms and para-clinical parameters in adults hospitalized with severe COVID-19 2020-10-22 anticipated 160 Complete https://irct.ir/trial/49775 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done based on the table of random numbers using Excel software and with the Randbetween command between 160samples. The bottles will be named including 40 bottles of syrup of control group (A) that have the same appearance as the intervention group, 40 bottles of syrup of intervention group 1 (B) that receive opiucough syrup, 40 bottles of syrup of intervention group 2 (C) that receive Noscatem syrup, 40 bottles of syrup of intervention group 3 (D) that receive Noscough syrup. Patients numbers from 000-040, 040-080 and 080-120, and 120-160 are considered for groups B, A, and C, and D respectively. 2 COVID-19. Intervention 1: Control group: Routine treatment based on physician's opinion and receive placebo syrup (dextrous syrup 60% and edible color, made by Mashhad University of Medical Sciences) 10 cc every 8 hours for 14 days. Intervention 2: Intervention group1: Opiucough Syrup - Receive routine treatment and 10 cc of Opiucough syrup (containing 17 mg noscapine per 10 ml, commercially available, Sepidaj Co.) every 8 hours for 14 days. Intervention 3: Intervention group2: Noscatem Syrup - Receive routine treatment and 10 cc of Noscatem syrup (containing 17 mg noscapine per 10 ml, commercially available, Temad Co.) every 8 hours for 14 days. Intervention 4: Intervention group3: Noscough Syrup - Receive routine treatment and 10 cc of Noscough syrup (containing 17 mg noscapine per 10 ml, commercially available, FaranSchimiCo.) every 8 hours for 14 days. 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 There is no more information
public Vahid Reza Askari
School of Persian and Complementary Medicine, Ferdowsi complex, Vakil-Abad Blvd., Azadi Sq., Mashhad
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2259 askariv@mums.ac.ir Mashhad University of Medical Sciences scientific Vahid Reza Askari
School of Persian and Complemantary Medicine, Ferdowsi Complex, Vakil-Abad Blvd., Azadi Sq., Mashhad
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2259 askariv@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients who are strongly suspected of having COVID 19 disease in terms of clinical findings and CT scan findings Patients who are clinically classified and hospitalized as severe Patients who have no organ damage. Confirmation of RT-PCR test for SARS-CoV-2 Age under 80 years confirmation of pneumonia by chest x-ray Blood oxygen saturation below 93% Relative stability of the cardiovascular status no limit 80 years Both Pregnant women Lactating women End stage patients U07.1 COVID-19 Placebo Treatment - Drugs Treatment - Drugs Treatment - Drugs Control group: Routine treatment based on physician's opinion and receive placebo syrup (dextrous syrup 60% and edible color, made by Mashhad University of Medical Sciences) 10 cc every 8 hours for 14 days Intervention group1: Opiucough Syrup - Receive routine treatment and 10 cc of Opiucough syrup (containing 17 mg noscapine per 10 ml, commercially available, Sepidaj Co.) every 8 hours for 14 days Intervention group2: Noscatem Syrup - Receive routine treatment and 10 cc of Noscatem syrup (containing 17 mg noscapine per 10 ml, commercially available, Temad Co.) every 8 hours for 14 days Intervention group3: Noscough Syrup - Receive routine treatment and 10 cc of Noscough syrup (containing 17 mg noscapine per 10 ml, commercially available, FaranSchimiCo.) every 8 hours for 14 days Recovery time from the time of randomization of the studied patients to the improvement of clinical symptoms based on 7 common signs of improvement reported by the World Health Organization. Timepoint: before and 14 days after initiation of the intervention. Method of measurement: Relative criteria based on clinical symptoms as follows, 1: not hospitalized with resumption to normal activities, 2: not hospitalized but unable to resume normal activities, 3: hospitalized without the need for oxygen therapy, 4: hospitalized requiring supplemental oxygen, 5: hospitalized and need to receive high-speed oxygen from the nose or non-invasive ventilation or both, 6: hospitalized and need to receive oxygen using invasive ventilation or oxygen delivery from non-pulmonary routes or both, 7: death. Hospital discharge. Timepoint: After initiation of the intervention. Method of measurement: Duration of hospitalization. Blood level of alanine aminotransferase (ALT). Timepoint: Before and 14 days after initiation of the intervention. Method of measurement: spectrometer. Blood urea nitrogen (BUN) level. Timepoint: Before and 14 days after initiation of the intervention. Method of measurement: spectrometer. Blood creatinine level. Timepoint: Before and 14 days after initiation of the intervention. Method of measurement: spectrometer. Blood level of aspartate aminotransferase (AST). Timepoint: Before and 14 days after initiation of the intervention. Method of measurement: spectrometer. Red blood cell counts. Timepoint: Before and 14 days after initiation of the intervention. Method of measurement: Cell Counter. White blood cell counts. Timepoint: Before and 14 days after initiation of the intervention. Method of measurement: Cell Counter. Hemoglobin level. Timepoint: Before and 14 days after initiation of the intervention. Method of measurement: Autoanalyzer. Hematocrit level. Timepoint: Before and 14 days after initiation of the intervention. Method of measurement: Autoanalyzer. Erythrocyte sedimentation rate. Timepoint: Before and 14 days after initiation of the intervention. Method of measurement: Wintrobe method. High-sensitivity C-reactive protein. Timepoint: Before and 14 days after initiation of the intervention. Method of measurement: ELISA kit. Mashhad University of Medical Sciences Approved 2020-05-23 Ethics committee of Mashhad University of Medical Sciences Deputy of Research and Technology of the University, Qurashi Building, Next to Hoveyzeh Cinema, University Street Mashhad Razavi Khorasan Iran (Islamic Republic of)