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IRCT20210218050404N1 IRCT 2021-03-10 Fasa University of Medical Sciences Control of inflammatory process in patients with coronavirus affected by ZAX.1399.C03 SICF (مطالعه التهاب و کرونا ویروس فسا) Evaluation of anti-inflammatory effect of ZAX.1399.C03 on airways inflammation in patients with coronavirus in home care 2021-06-21 anticipated 60 Complete https://irct.ir/trial/54447 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is performed on patients referred to health centers and infectious disease specialists in the present study. For home care patients, the admit code along with the relevant information (medication regimen, age and sex, severity of the disease and severity of symptoms) is provided by the expert to the patient. The relevant expert divides the patients into two similar groups based on the treatment regimen, age group, sex, severity of the disease and symptoms, and randomly divides one group into group A and one group into group B using the patient code numbers. For randomization, the permutation block method with the number of blocks of 6 is done using Random allocation software, Blinding description: For blinding, the study of the drug and placebo with the names A and B in the same package are prescribed by the doctor to the patient. (Capsules according to The principles of pharmacy are created by a pharmacist.) A patient-level study, outcome evaluator, and statistical analyst of the results will be blind. 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 be aware of the coding. The results of the two groups under the headings of groups A and B will be delivered to the statistical analyzer. 2-3 Incidence of inflammation due to the mechanism of COVID19. Intervention 1: Intervention group: The medicinal composition of ZAX.1399.C03 in two daily doses, is consumed for 7 to 14 days. Intervention 2: Control group: The composition of popcorn flour is consumed, in two daily doses, for a period of 7 to 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: Dr. Seyyed Amin Kouhpayeh Email address: kouhpayeha@gmail.com Contact number: 09177087247 Address: Department of Pharmacology, Fasa University of Medical Sciences and Health Services, Fasa, Iran. Email Address: Amindakhiliardestani@yahoo.com Contact number: 09228584505 Address: Fasa University, Fasa University of Medical Sciences and Health Services, Fasa, Iran. How to obtain: 1. Contact the scientific or general respondent of the study 2. Sending their official request to the respondent 3. Apply to the University Research Council 4. In case of a positive response from the council, it will be provided to the applicant in accordance with the ethical principles. 5. The total duration of the process from the time of receiving the request is 20 days. Comments:
public Amin Dakhili Ardestani
Fasa city, Ibn Sina Square, Fasa University of Medical Sciences
Fasa Iran (Islamic Republic of) 7461686688 +98 71 5335 0996 a.dakhili@fums.ac.ir Fasa University of Medical Sciences scientific Seyyed Amin Kouhpayeh
Fasa city, Ibn Sina Square
Fasa Iran (Islamic Republic of) 7461686688 +98 71 5335 0996 kouhpayeha@gmail.com Fasa University of Medical Sciences Iran (Islamic Republic of) COVID-19 is detected by PCR laboratory diagnostic kit Age over 18 years Both sexes (male and female) Having informed and written consent to participate in the study No history of any allergies No uncontrolled hypertension Do not take anticoagulants (aspirin, Plavix, warfarin) Not pregnant and breastfeeding No diabetes in the person 18 years no limit Both Disagreement of the responsible physician of the patient before randomization History of any allergies to drugs, various substances, food and ... History of liver and kidney disease Patient disagreement Inability of the patient to take the drug for any reason History of hypertension and heart disease U07.1 COVID-19 Treatment - Drugs Placebo Intervention group: The medicinal composition of ZAX.1399.C03 in two daily doses, is consumed for 7 to 14 days. Control group: The composition of popcorn flour is consumed, in two daily doses, for a period of 7 to 14 days. Inflammatory mediators of IL6. Timepoint: Before the intervention and seven days after the start of consumption of mango leaf extract. Method of measurement: ELISA test. Dry cough. Timepoint: Daily. Method of measurement: Check list. Sputum cough. Timepoint: Daily. Method of measurement: Check list. Shortness of breath. Timepoint: Daily. Method of measurement: Check list. Gastrointestinal manifestations. Timepoint: Daily. Method of measurement: Check list. Fever. Timepoint: Daily. Method of measurement: Check list. Muscle and joint pain. Timepoint: Daily. Method of measurement: Check list. Fatigue and laziness. Timepoint: Daily. Method of measurement: Check list. Shiver. Timepoint: Daily. Method of measurement: Check list. Odor and taste activity. Timepoint: Daily. Method of measurement: Check list. Hospitalization in medical centers with normal activity. Timepoint: daily. Method of measurement: Check list. Fasa University of Medical Sciences Approved 2021-02-06 Ethics Committee of Fasa University of Medical Sciences Fasa city, Ibn Sina square Fasa Fars Iran (Islamic Republic of)