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IRCT20210203050233N1 IRCT 2021-04-14 National Institute for Medical Research Development (NIMAD) Assessment of effect of crocin on Covid-19 patients Assessment of additive effect of crocin in Covid-19 patients 2021-02-19 anticipated 60 Complete https://irct.ir/trial/54085 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization method (using https://www.Randomization.com-generated sequence) In this method, using website https://www.Randomization.com that generates the random number sequences, the random number sequences are determined for the required sample size (n=30 in each group). Following, after patients enter the study based on the inclusion criteria, according to the list of the random number sequences generated, individuals are assigned to one of the intervention and placebo groups, and this continues until the number of patients in each group is completed, Blinding description: Masking Description: Drugs will be packed and labelled . No information on the randomization schedule or the contents of drug packs will be available to patients, investigators, care providers and outcomes assessors and they will be blinded. The patients will be blinded in the sense that they do not know whether they were receiving the placebo or crocin. They randomly assign to one of the two groups. The investigators doing the interventions will be blinded as to the contents of the drug using drugs labelling. Also care providers and outcomes assessors shall be blinded as to what group the patient belongs to. One person in the project who does not belong to any of the groups of patients, investigators, care providers and outcomes assessors, will oversee on blinding method. 3 Covid 19. Intervention 1: Intervention group: In this group, patients (n=30) will receive 15 mg crocin tablet (Krocina™, made by Sami Saz Company) , twice a day, for 14 days. Intervention 2: Control group: In this group, patients (n=30) will receive placebo tablet (Containing Avicel, made by Sami Saz Company), twice a day, for 14 days. No - There is not a plan to make this available Justification or reason for not sharing IPD is Dr. Ramin Rezaee is committed to presenting all the achievements of the project in accordance with the framework of the National Institute for Medical Research Development in the Islamic Republic of Iran.
public Ramin Rezaee
Ibn Sina St., Imam Reza Hospital Square, Imam Reza Hospital
Mashhad Iran (Islamic Republic of) ٩١٣٧٩١٣٣١۶ +98 51 3802 2097 RezaeeRA@mums.ac.ir Mashhad University of Medical Sciences scientific Ramin Rezaee
Ibn Sina St., Imam Reza Hospital Square, Imam Reza Hospital
Mashhad Iran (Islamic Republic of) ٩١٣٧٩١٣٣١۶ +98 51 3802 2097 RezaeeRA@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 1. Confirmed cases of Covid-19 2. Patients admitted to hospital Covid-19 general wards 3. Being 20-60 years old, of either sex. 4. Ability to sallow oral medication. 5. Patients without immunodeficiency and gastrointestinal disorders 6. Not being pregnant/breast feeding 20 years 60 years Both 1. Being allergic to saffron/crocin 2. Inability to swallow oral medication during admission U07.1 COVID-19, virus identified Treatment - Drugs Placebo Intervention group: In this group, patients (n=30) will receive 15 mg crocin tablet (Krocina™, made by Sami Saz Company) , twice a day, for 14 days. Control group: In this group, patients (n=30) will receive placebo tablet (Containing Avicel, made by Sami Saz Company), twice a day, for 14 days. Cell blood count (CBC). Timepoint: on days 0, 7 and 14. Method of measurement: CBC will be measured by auto analyzer. Differential cell counts will be performed in stained peripheral blood smear (Wright-Giemsa) under light microscope. Serum C-reactive protein (CRP) level. Timepoint: on days 0, 7 and 14. Method of measurement: CRP serum level will be measured using standard ELISA kits. TNF-α serum level. Timepoint: on days 0, 7 and 14. Method of measurement: TNF-α serum level will be measured using standard ELISA kits. LDH serum level. Timepoint: on days 0, 7 and 14. Method of measurement: LDH serum level will be measured using standard ELISA kits. Erythrocyte sedimentation rate (ESR). Timepoint: on days 0, 7 and 14. Method of measurement: Sedimentation Analyzer. A. Clinical signs and symptoms: fever, cough, dyspnea, myalgia, chill, headache, respiratory rate, weakness, chest pain, nausea, vomiting, gastro-intestinal manifestations, O2 saturation. Timepoint: On days 0 and 14. Method of measurement: Clinical signs and symptoms will be recorded using the checklist. Lung involvement. Timepoint: On days 0 and 14. Method of measurement: Lung radiography assessment will be performed by lung high-resolution computed tomography (HRCT). National Institute for Medical Research Development (NIMAD) Approved 2020-11-18 National Institute for Medical Research Development No. 21, Besat St., West Fatemi St., Tehran Tehran Tehran Iran (Islamic Republic of)