]>
IRCT20200607047675N1 IRCT 2020-06-15 Mashhad University of Medical Sciences Evaluation of the effectiveness of traditional medicine combination based on the Ferula assa-foetida gum - Tragacanth in Participants with Moderate to Severe Coronavirus Disease (COVID-19) A prospective randomized controlled trial comparing the effectiveness of traditional medicine combination based on the Ferula assa-foetida gum - Tragacanth with moderate to severe Coronavirus disease (COVID-19) compared to standard treatment 2020-06-19 anticipated 122 Complete https://irct.ir/trial/48700 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomized in a 1:1 ratio into one of the traditional treatment and standard treatment using the SPSS randomization plan. The date and time of randomization will be recorded. Allocation concealment will be done with the sealed envelope method, Blinding description: The treatment assignment will remain unknown until the patient is randomized. Physicians who treat patients and the patients will not be blinded. Radiologists, physicians who assess outcomes, and the statistician analyzing the data all will be blinded. 3 COVID-19. Intervention 1: Intervention group: 300mg of soft Ferula gum and 150mg of soft tragacanth gum: twice a day, and the national guidelines for the treatment of COVID-19. Intervention 2: Control group: the national guidelines for the treatment of COVID-19. Yes - There is a plan to make this available What will be shared: The study protocol, statistical analytic plan informed consent forms will be shared as supplementary material at the time of publication of results. When: At the time of publication To whom: Will be publically available as a supplement accompanying the published article. Conditions: To interpret the findings of the published study, and to use as a reference for future research Where to obtain: On the website of the journal that will publish the research How to obtain: They will be publically available. Comments:
public Nayereh Esmaeilzadeh
No.25, Sanabad Ave.
Mashhad Iran (Islamic Republic of) 9185684538 +98 51 3841 5222 esmaeilzadehn1@mums.ac.ir Mashhad University of Medical Sciences scientific Dr. HamidReza Bahrami Taghanaki
East Door of Ferdowsi University, medical School, Mashhad University of Medical sconces
Mashhad Iran (Islamic Republic of) 9177899191 +98 51 3884 8930 bahramihr@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) PCR confirmed diagnostic chest CT scan Consent for voluntary participation Hospitalization 18 years 75 years Both Patients with end stage heart failure Recent cardiac intervention (less than 2 months): coronary angioplasty, ICD, CABG, Valvuloplasty or replacement Pulmonary fibrosis or advanced COPD End stage kidney or liver disease Pregnant or lactating ladies Patients on immunosuppressive therapy Active tuberculosis Active hepatitis The critical stage of COID19 U07.1 COVID-19 Treatment - Drugs Treatment - Drugs Intervention group: 300mg of soft Ferula gum and 150mg of soft tragacanth gum: twice a day, and the national guidelines for the treatment of COVID-19 Control group: the national guidelines for the treatment of COVID-19 Oxygen saturation (≥94% on room air). Timepoint: Day 1 and 14. Method of measurement: pulse oximetry. Lymphocyte count. Timepoint: Day 1 and 14. Method of measurement: Complete Blood Count. Mashhad University of Medical Sciences Approved 2020-06-06 Ethics committee of Mashhad University of Medical Sciences Qurashi Building, University Street Mashad Razavi Khorasan Iran (Islamic Republic of)