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IRCT20211029052904N1 IRCT 2021-12-30 Artesh University of Medical Sciences The effects of Skekar Tighal on covid-19 The effects of Trehala Manna (Shekar Tighal) on inflammatory and biochemistry biomarkers, and clinical outcomes in Covid-19 patients; A randomized double-blind placebo-controlled trial 2021-12-06 anticipated 60 Complete https://irct.ir/trial/59668 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Each patient will be recruited into intervention or control group using a valid random number making website: https://www.sealedenvelope.com/simple-randomiser/v1/lists. Eligible patients will be randomly allocated in a ratio of 1:1 to receive intervention or placebo with a block size of four, Blinding description: The sealed and opaque envelopes prepared by a blinded herbal pharmacologist along with similar sachets that only varied in label (A or B) containing Trehala Manna or placebo. These are provided to the first investigator without specifying which package is the intervention or the placebo. The content of envelope determines A or B. After implementing statistical analysis, we will open envelopes to reveal labels. N/A Covid-19. Intervention 1: Intervention group: 2 sachets of Trehala manna (refined Shekar Tighal) daily, 5 grams per sachet (a total of 10 grams per day in the form of a drink solution) for 7 days. In addition to the usual treatment protocols for patients. Intervention 2: Control group: 2 sachets of Maltodextrin daily (each sachet contains 5 grams and a total of 10 grams as a drink solution). In addition to the usual treatment protocols for patients. Yes - There is a plan to make this available What will be shared: Information about the study will be published after the nonidentifying individuals and when the project is completed. When: 6 months after final manuscript To whom: Only for researchers working in academic and scientific institutions Conditions: For further analysis Where to obtain: Mahdi keshani Mahdikeshani1@yahoo.com How to obtain: After reviewing the request and full transparency about the purposes of using the data, the data will be provided. Comments:
public Mahdi keshani
West Fatemi St, Shahid etemadzadeh St
Tehran Iran (Islamic Republic of) 1411718541 +98 21 4382 2449 mahdikeshani1@yahoo.com Artesh University of Medical Sciences scientific SeyedMahdi Mirghazanfari
West Fatemi St, Shahid etemadzadeh St
Tehran Iran (Islamic Republic of) 1411718541 +98 21 8609 6350 smmirghazanfari@gmail.com Artesh University of Medical Sciences Iran (Islamic Republic of) Age between 18-65 Written informed consent Covid-19 patients (PCR positive test or clinical symptoms such as fever > 38, respiratory rate ≥ 24, dry cough, myalgia, asthenia, anosmia, and or anorexia Admission to general corvid-19 unit in hospital Patients who estimate that reside in hospital at least 7 days. Non ICU patients 18 years 65 years Both Did not write informed consent Pregnancy and lactation Smoking Usage of other herbal medicine Hypertension (definition by ACC/AHA SBP/DBP ≥ 130/80) J12.81 Pneumonia due to SARS-associated coronavirus Treatment - Other Placebo Intervention group: 2 sachets of Trehala manna (refined Shekar Tighal) daily, 5 grams per sachet (a total of 10 grams per day in the form of a drink solution) for 7 days. In addition to the usual treatment protocols for patients. Control group: 2 sachets of Maltodextrin daily (each sachet contains 5 grams and a total of 10 grams as a drink solution). In addition to the usual treatment protocols for patients. C reactive protein. Timepoint: At baseline (day 0) and end of the study (day 8). Method of measurement: ELISA commercial diagnostic kit. Assess the severity of cough. Timepoint: At baseline (day 0) and end of the study (day 8). Method of measurement: Visual Analogue Scale. Alanine transaminase. Timepoint: At baseline (day 0) and end of the study (day 8). Method of measurement: Spectrophotometry. Aspartate transaminase. Timepoint: At baseline (day 0) and end of the study (day 8). Method of measurement: Spectrophotometry. Hospitalization days. Timepoint: Continuous. Method of measurement: Discharge day minus first day. Artesh University of Medical Sciences Approved 2021-12-22 Ethics committee of AJA University of Medical Sciences West Fatemi Ave, Etemadzadeh Ave Tehran Tehran Iran (Islamic Republic of)