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IRCT20170315033086N7 IRCT 2020-11-12 Shahid Beheshti University of Medical Sciences An Investigation of the impact of Faramir on the clinical symptoms in patients with COVID-19 An Investigation of the impact of Faramir containing Salvia officinalis leaf extract on the level of serum IL-6 in patients with COVID-19 2020-11-21 anticipated 128 Complete https://irct.ir/trial/52223 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization is designed based on four-sized block randomization procedure. A non-ordered computer sequence list including the patient-assigned code and the order of recruitment is generated by an epidemiologist using Stata v.15. Given the block size of 4, there are 6 possible ways to equally assign participants to each treatment group. Therefore recruitment of participants to each treatment category is randomized and unpredictable. Following this randomization, an equal number of participants is randomly assigned to each treatment group. 2 COVID-19. Intervention 1: Intervention group: Patients who receive natural product Faramir containing Salvia officinalis extract (750 mg oral caplet, 6 times a day, every 4 hours and for 8 days) along with standard treatments.The active ingredient of the medicinal species of ُSalvia officinali is prepared from the leaves of the medicinal species of the plant by Meem Pharmaceutical Factory and will be stored in closed containers in conditions away from light and moisture. Intervention 2: Control group: Patients who receive only standard treatments. Yes - There is a plan to make this available What will be shared: collected de-identified IPD, IPD collected for the primary outcome measure only When: De-identified data will be available starting from April, 2025 To whom: Academics employed at various research/university institutions and the industry. Conditions: No specific condition are specified. Where to obtain: Recruitment center How to obtain: 1- The applicant would be asked to provide a written formal request letter, containing the importance of the data and the project processes. 2- Following the receipt of request letter, the data would be provided in no more than two weeks. Comments:
public Minoosh Shabani
Makhsoos st., Lashgar junction
Tehran Iran (Islamic Republic of) 1333635445 +98 21 5541 9005 minoosh.shabani@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Somayeh Mahmoodi Baram
Niyayesh Highway, Shahid Beheshti University of Medical Sciences Incubator Center
تهران Iran (Islamic Republic of) 1996835113 +98 21 9666 1028 info@behbalin.com Behbalin Iran (Islamic Republic of) Covid-19 infection confirmed by positive PCR-viral load test Some or all of the symptoms include fever, fatigue, muscle aches (headache), headache, cough, chest tightness, and shortness of breath Need to be hospitalized 18 years 75 years Both Malignant tumors and other acute systemic diseases Co-infection with HIV and tuberculosis History of asthma, asthma-like attacks and respiratory problems Life-threatening comorbidity Use of any other herbal substance Homofusion and plasmapheresis Drug allergy Need for hospitalization in the intensive care unit (ICU) Pregnancy Lactation B34.2 Coronavirus infection, unspecified Treatment - Drugs Other Intervention group: Patients who receive natural product Faramir containing Salvia officinalis extract (750 mg oral caplet, 6 times a day, every 4 hours and for 8 days) along with standard treatments.The active ingredient of the medicinal species of ُSalvia officinali is prepared from the leaves of the medicinal species of the plant by Meem Pharmaceutical Factory and will be stored in closed containers in conditions away from light and moisture. Control group: Patients who receive only standard treatments Survival rate. Timepoint: 30 days after study commencement. Method of measurement: Deaths record. Discharge duration. Timepoint: Hospitalization day and discharge day. Method of measurement: Record the number of hospitalization days. Virus clearance. Timepoint: At the commencement of the investigation and 8 days after taking. Method of measurement: Polymerase chain reaction (PCR). Serum Inflammatory Factors- Interleukin 6. Timepoint: At the beginning of the study and 8 days after the study commencement. Method of measurement: ELISA Method. Serum Inflammatory Factors- c reactive protein (CRP). Timepoint: At the beginning of the study and 8 days after the study commencement. Method of measurement: ELISA Method. Serum Inflammatory Factors- Erythrocyte sedimentation rate (ESR). Timepoint: At the beginning of the study and 8 days after the study commencement. Method of measurement: Western green method. Behbalin Approved 2020-11-10 Ethics committee of Shahid Beheshti University of Medical Sciences, School of Medicine Ground floor, medical faculty, Koodakyar Alley, Daneshjoo Blvd, Velenjak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)