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IRCT20200323046841N1 IRCT 2020-03-28 Mashhad University of Medical Sciences Efficacy evaluation of an herbal compound in COVID-19 Efficacy evaluation of an herbal compound “Fluherb” on clinical symptoms and paraclinical parameters in highly suspected COVID-19 patients: a controlled randomized clinical trial. 2020-03-28 anticipated 60 Complete https://irct.ir/trial/46715 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Balanced block randomization, Blinding description: In this study, patients will be informed by consent form that they would either be in the intervention group or the control group, but they won't be aware of the type of medication. Nurses who supply the drug are also unaware of its content because the appearance, taste, color, and prescription of the drug are similar, but the code on the drug will be different. The written codes on the drugs are random and only the pharmacist's partner is aware of the drug type and the inserted code on it. The patient data collector and the project statistical partner are also unaware of the type of intervention. As the control group uses placebo, which is similar in appearance, taste, color, and prescription, patients will be unaware of the type of drug being administered. 2-3 COVID-19. Intervention 1: Intervention group: This group will receive routine treatments for COVID-19 disease and will receive a suspension of extract of five herbs. Patients will receive a combination consisted of aqueous extract of 10 grams of hyssop leaf, 5 grams of Plantain seed, 10 grams of purslane seed , 10 grams of licorice root and 5 grams of turmeric, orally, in three divided doses daily. The intervention duration is five days. Intervention 2: Control group: This group receive routine treatments for COVID-19 disease and placebo. Placebo will be given as an oral syrup, three servings a day. For the placebo syrup, a non-absorbable sweetened drop of stevia (a product from a pharmaceutical company), authorized oral dyes are used to make the color and taste relatively similar to the original drug. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is If participants agree, it will be released
public Mahdi Yousefi
School of Persian and Complementary Medicine; University Campus; Azadi Square
Mashhad Iran (Islamic Republic of) 9177745346 0091 51 38848930 yousefim@mums.ac.ir Mashhad University of Medical Sciences scientific Mahdi Yousefi
School of Persian and Complementary Medicine; University Campus; Azadi Square
Mashhad Iran (Islamic Republic of) 9177745346 +98 51 3876 6148 yousefim@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Hospitalized patients with clinical and CT scan findings strongly suspected of COVID -19 Relative stability in cardiovascular status Moderate and severe cases No organ damage no limit 70 years Both Pregnant and lactating women End stage patients U07.1 COVID-19 Treatment - Drugs Placebo Intervention group: This group will receive routine treatments for COVID-19 disease and will receive a suspension of extract of five herbs. Patients will receive a combination consisted of aqueous extract of 10 grams of hyssop leaf, 5 grams of Plantain seed, 10 grams of purslane seed , 10 grams of licorice root and 5 grams of turmeric, orally, in three divided doses daily. The intervention duration is five days. Control group: This group receive routine treatments for COVID-19 disease and placebo. Placebo will be given as an oral syrup, three servings a day. For the placebo syrup, a non-absorbable sweetened drop of stevia (a product from a pharmaceutical company), authorized oral dyes are used to make the color and taste relatively similar to the original drug. Changing the patient's clinical status in the COVID-19 clinical classification table. Timepoint: Before and after intervention. Method of measurement: Clinical and Paraclinical Indicators in COVID-19 Classification Table. Cell blood count. Timepoint: Before and after the intervention. Method of measurement: Cell conuter. Liver enzymes. Timepoint: Before and after the intervention. Method of measurement: spectrometer. Mashhad University of Medical Sciences Approved 2020-03-14 Ethics committee of Mashhad University of Medical Sciences School of Persian and Complementary Medicine; University Campus; Azadi Square Mashhad Razavi Khorasan Iran (Islamic Republic of)