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IRCT20210510051243N1 IRCT 2021-05-25 Arak University of Medical Sciences Chitosan supplementation and Coronavirus The effect of chitosan supplementation on clinical symptoms in patients with COVID-19 2021-05-31 anticipated 80 Complete https://irct.ir/trial/56289 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients will be randomly assigned to two groups. To do this, they will be divided into 2 equal groups by permuted block randomization method with 4 and 8 block sizes. The online Sealed envelope site will be used in such a way that the randomization sequence is generated by the mentioned method and a unique code is assigned to each of them. The randomization sequence will remain with the epidemiologist colleague, and patients will be assigned to the intervention and control groups, respectively, in accordance with the randomization sequence, Blinding description: This study will be done as a double blinded study. To blind the participants, a placebo that is similar in color, smell, taste, shape, size and weight to the main drug will be used. The outcomes will be assessed by a person who is unaware of assigning individuals to groups. The drugs will be provided to the researcher and the patient in similar packages, each of which has a unique code. At the end of the study, the decoding process is performed based on the randomization sequence and unique codes of each individual. 2 COVID-19 infection. Intervention 1: Intervention group: receive 10 cc of the same 2.5% chitosan syrup (250 mg pharmacological grade chitosan) during the day, for 2 weeks.All syrups are prepared by the Barij Essence Pharmaceutical Co., Kashan, Iran. Intervention 2: Control group: Participants in the control group will receive 10 cc of identical placebo syrup (CMC with the same viscosity of chitosan syrup) during the day, for 2 weeks. All syrups are prepared by the Barij Essence Pharmaceutical Co., Kashan, Iran. Yes - There is a plan to make this available What will be shared: The non-identifiable individual participant data collected in this study will be shared. Also, The protocol, results, and statistical analysis of the current study will be published in the relevant articles. When: The non-identifiable individual participant data will become available after the publication of the relevant articles. To whom: The non-identifiable individual participant data will become available to other researchers in academic institutions. Conditions: The non-identifiable individual participant data can only be used for research. Where to obtain: The non-identifiable individual participant data will be obtainable by sending an e-mail to Dr. Hamid Abtahi (Email: abtahi@arakmu.ac.ir). How to obtain: Other researchers in academic institutions can send their request by e-mail to Dr. Hamid Abtahi (Email: abtahi@arakmu.ac.ir). The data will be sent to them after consulting and approving the research team. Comments:
public Hamid Abtahi
Medical and Molecular Research Center, School of Medicine, Pardis site of University of Medical Sciences, Basij Square, Arak city
Arak Iran (Islamic Republic of) 3848176341 +98 86 3417 3502 abtahi@arakmu.ac.ir Arak University of Medical Sciences scientific Hamid Abtahi
Medical and Molecular Research Center, School of Medicine, Pardis site of University of Medical Sciences, Basij Square, Arak city
Arak Iran (Islamic Republic of) 3848176341 +98 86 3417 3502 abtahi@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Age between 20 to 75 years, Willingness to participate with written informed consent, Diagnosis of coronavirus based on the PCR test. 20 years 75 years Both Current use of warfarin, Presence of sensitivity to seafood. U07.1 COVID-19; virus identified Treatment - Drugs Placebo Intervention group: receive 10 cc of the same 2.5% chitosan syrup (250 mg pharmacological grade chitosan) during the day, for 2 weeks.All syrups are prepared by the Barij Essence Pharmaceutical Co., Kashan, Iran. Control group: Participants in the control group will receive 10 cc of identical placebo syrup (CMC with the same viscosity of chitosan syrup) during the day, for 2 weeks. All syrups are prepared by the Barij Essence Pharmaceutical Co., Kashan, Iran. Respiratory Rate. Timepoint: day 1 and day 14. Method of measurement: The number of breaths a person takes per minute. Severity of lung involvement. Timepoint: day 1 and day 14. Method of measurement: Chest CT scan. High-sensitivity C-reactive protein. Timepoint: Day 1 and day 14. Method of measurement: Colorimetric method. Erythrocyte Sedimentation Rate. Timepoint: Day 1 and day 14. Method of measurement: Colorimetric method. Severity and number of coughs. Timepoint: Day 1 and day 14. Method of measurement: Cough visual analogue scale (VAS). Body temperature. Timepoint: Day 1 and day 14. Method of measurement: Clinical Thermometer. Alanine aminotransferase Activity. Timepoint: Day 1 and day 14. Method of measurement: Colorimetric method. Aspartate aminotransferase Activity. Timepoint: Day 1 and day 14. Method of measurement: Colorimetric method. Superoxide dismutase Activity. Timepoint: Day 1 and day 14. Method of measurement: Colorimetric method. Albumin. Timepoint: Day 1 and day 14. Method of measurement: Colorimetric method. Death outcome. Timepoint: Day 14. Method of measurement: Percentage of fatal patients in two groups. Arak University of Medical Sciences Approved 2021-04-28 Ethics committee of Arak University of Medical Sciences Medical and Molecular Research Center, School of Medicine, Pardis site of University of Medical Sciences, Basij Square, Arak city Arak Markazi Iran (Islamic Republic of)