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IRCT20210218050404N4 IRCT 2022-02-24 Fasa University of Medical Sciences Evaluation of therapeutic effects of ZAX.1400.C05 on patients with coronavirus Evaluation of therapeutic effects of ZAX.1400.C05 on symptomatic treatment and clinical features of patients with coronavirus: a randomized controlled clinical trial 2022-04-03 anticipated 300 Complete https://irct.ir/trial/62040 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study was performed on patients with coronary artery and hospitalized in Vali-e-Asr Hospital in Fasa. Takes place. For hospitalized patients, the hospital code along with the relevant information (medication regimen, age and sex, severity of disease and severity of symptoms) is provided by the expert to the patient. The relevant expert divides the patients into a group of 250 people and a group of 50 people based on the treatment regimen, age group, sex, severity of the disease and symptoms, and randomly using the code numbers A, B, C, D and E will be done. One of the codes will be for the placebo and the rest will be for the drug. For randomization, the permutation block method is done using Random allocation software, Blinding description: For the blinding of the study, the drug (capsule containing ZAX.1400.C05) and placebo (including capsule of roasted corn flour) are named in the same package and are prescribed to the patient by the doctor. (Capsules are made according to the principles of pharmacy by a pharmacist.) Before prescribing the drug to the patient, the plan is introduced and written consent is received. Study at the patient level, outcome assessor and statistical analyzer of the results will be blinded. Only the manufacturer of the drug can decode the contents of each capsule based on the original retained form of the randomization results. The person in charge of drug delivery and the patient, the doctor, the person in charge of evaluating the consequences will not know about the codings. The results of the two groups under the headings of groups A, B, C, D and E will be submitted to the statistical analyzer. 3 COVID-19 viral disease. Intervention 1: Intervention group: Dried powder of ZAX.1400.C05, made in the laboratory of medicinal plants of Fasa University of Medical Sciences, based on plant flavonoids, in the form of capsules, is consumed in four daily doses for 14 days. Intervention 2: Control group: The composition of popcorn flour, made in the laboratory of medicinal plants of Fasa University of Medical Sciences, in the form of capsules, is consumed in four daily doses for 14 days. Yes - There is a plan to make this available What will be shared: Some of the information obtained will be available based on changes in initial outcomes. When: Start of access period 6 months after production and publication of results To whom: People engaged in research in medical universities of the country Conditions: The methods and data contained in this clinical trial should be used solely to advance similar projects. It is also necessary to mention the research center of this study (Fasa University of Medical Sciences) if information is used Where to obtain: Amin Dakhili Ardestani, Email Address: Amindakhiliardestani@yahoo.com Contact Number: 09228584505 Address: Fasa University, Ibn Sina Square, Fasa University of Medical Sciences and Health Services How to obtain: 1. Contacting the general respondent of study 2. Sending his formal request to respondent 3. The application form in the University Research Council 4. In case of a positive response from the council, it will be provided to the applicant by the ethical principles. 5. The total duration of the process is 20 days. Comments:
public Amin Dakhili Ardestani
Ibn Sina square, Fasa
Fasa Iran (Islamic Republic of) 7461686688 +98 71 5335 9507 amindakhiliardestani@yahoo.com Fasa University of Medical Sciences scientific Sohrab Najafipour
Ibn Sina Square, Fasa.
Fasa Iran (Islamic Republic of) 7461686688 +98 71 5335 9507 sohrabnajafipour@yahoo.com Fasa University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of COVID-19 disease by laboratory diagnostic kit from patient sputum Patient hemoglobin saturation (SPO2) between 85% and 93% in patients Detection of lung involvement by CT scan in patients The number of breaths per minute is between 25 and 30 in patients no limit no limit Both History of allergies to herbal products Pregnancy and lactation Existence of liver and kidney diseases Inability of the patient to receive oral medication B34.2 Coronavirus infection, unspecified Treatment - Drugs Placebo Intervention group: Dried powder of ZAX.1400.C05, made in the laboratory of medicinal plants of Fasa University of Medical Sciences, based on plant flavonoids, in the form of capsules, is consumed in four daily doses for 14 days. Control group: The composition of popcorn flour, made in the laboratory of medicinal plants of Fasa University of Medical Sciences, in the form of capsules, is consumed in four daily doses for 14 days. Clinical signs. Timepoint: daily. Method of measurement: Evaluation form (questionnaire). (VAS) Visual Analogue Scale. Timepoint: daily. Method of measurement: check list. ESR (Erythrocyte sedimentation rate). Timepoint: Zero and fourteen days after the start of the intervention. Method of measurement: Standard sedimentation rate method. C-Reactive Protein – CRP. Timepoint: Zero and fourteen days after the start of the intervention. Method of measurement: Autoanalyzer. Liver enzymes SGOT, ALT, SGPT. Timepoint: Zero and fourteen days after the start of the intervention. Method of measurement: Autoanalyzer. Renal indicators BUN, Creatinine. Timepoint: Zero and fourteen days after the start of the intervention. Method of measurement: Autoanalyzer. Duration of hospitalization. Timepoint: daily. Method of measurement: check list. Mortality. Timepoint: daily. Method of measurement: check list. Fasa University of Medical Sciences Approved 2022-01-05 Ethics Committee of Fasa University of Medical Sciences Ibn Sina square, Fasa. Fasa Fars Iran (Islamic Republic of)