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IRCT20080901001157N16 IRCT 2020-04-08 HomaPharmed Company Effect of IMFLUNA herbal compound on covid-19 pneumonia symptoms Evaluation of the effect of IMFLUNA herbal compound on the improvement of covid-19 pneumonia symptoms in patients referred to Baqiyatallah Hospital 2020-03-30 anticipated 60 Complete https://irct.ir/trial/46907 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A random number table and block randomization method is used. In this method 60 eligible patients are assigned into 30 blocks of 2 patients. Then, each of the 2 patients in the block is randomly assigned to take herbal medicine or placebo, so that 30 patients assigned to each group, Blinding description: Package for herbal and placebo is labeled with code B or A. Other specifications on the labels are identical. Physicians, nurses, patients, data collectors and those who evaluate the outcome are unaware of the drug and placebo group. Only the expert who has done the capsules packaging is aware of the contents of the packages or what is code A or B. Patients are aware that they are either in the herbal drug or placebo groups, but they are not aware of the type of group they are in. 1-2 COVID-19 pneumonia. Intervention 1: Intervention group: patients in this group in addition to receiving standard medications, take two 500 mg capsules of the herbal compound three times a day after meals. The herbal capsule contains a mixture of medicinal plant extract powder and is manufactured by the HomaPharmed Pharmaceutical Company. The herbal capsule is given as a supplement to patients for two weeks along with standard medications. Intervention 2: Control group: patients in this group in addition to receiving standard medications, take two 500 mg capsules of the placebo three times a day after meals. The placebo capsule contains a toasted powder is manufactured by the HomaPharmed Pharmaceutical Company. The placebo capsule is given as a supplement to patients for two weeks along with standard medications. 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 There is no further information
public Fallah Huseini Hasan
Kavosh Blvd., Supa Blvd., Poleh Kordan
karaj Iran (Islamic Republic of) 3365166571 +98 26 3476 4010 h.fallah@acecr.ac.ir Institute of Medicinal Plants scientific Mohammadreza Gholibeikian
Enghelab Square, North Jamalzadeh St., Nader Alley., No 26
Tehran Iran (Islamic Republic of) 1418635643 +98 21 6276 9000 mgholibeikian@gmail.com HomaPharmed Company Iran (Islamic Republic of) Patients infected with symptomatic covid-19 pneumonia virus Confirmation of coronavirus infection with chest CT scan and PCR test Age 20 to 70 years who have the ability to take oral medication Personal desire to participate in the project and the signing of a written consent 20 years 70 years Both Patients with severe dyspnea Patients with reduced level of consciousness or need hospitalization in intensive care units Patients with swallowing disorders or possibility of aspiration of food or unable to take the drug orally Patients with respiratory failure require mechanical ventilation Patients with resistant hypoxemia Patients with organ transplantation; malignant disease; treated with corticosteroids or chemotherapy Patients with uncontrolled blood pressure, uncontrolled diabetes, cardiovascular disease and underlying respiratory disease Pregnant women RA01.0 Confirmed diagnosis of COVID-19 Treatment - Drugs Placebo Intervention group: patients in this group in addition to receiving standard medications, take two 500 mg capsules of the herbal compound three times a day after meals. The herbal capsule contains a mixture of medicinal plant extract powder and is manufactured by the HomaPharmed Pharmaceutical Company. The herbal capsule is given as a supplement to patients for two weeks along with standard medications. Control group: patients in this group in addition to receiving standard medications, take two 500 mg capsules of the placebo three times a day after meals. The placebo capsule contains a toasted powder is manufactured by the HomaPharmed Pharmaceutical Company. The placebo capsule is given as a supplement to patients for two weeks along with standard medications. Blood oxygen saturation. Timepoint: At beginning and regularly during study. Method of measurement: Pulse Oximeter. Respiratory Rate. Timepoint: At beginning and regularly during study. Method of measurement: Respiratory Count. Lung inflammation. Timepoint: At beginning and end of the study. Method of measurement: Chest CT scan. C-reactive protein. Timepoint: At beginning and end of the study. Method of measurement: Intravenous blood test. CBC. Timepoint: At beginning and end of the study. Method of measurement: Intravenous blood test. ESR. Timepoint: At beginning and end of the study. Method of measurement: Intravenous blood test. BUN. Timepoint: At beginning and end of the study. Method of measurement: Intravenous blood test. Creatinine. Timepoint: At beginning and end of the study. Method of measurement: Intravenous blood test. K. Timepoint: At beginning and end of the study. Method of measurement: Intravenous blood test. Na. Timepoint: At beginning and end of the study. Method of measurement: Intravenous blood test. Cough. Timepoint: At beginning and regularly during the study. Method of measurement: Count. Fever. Timepoint: At beginning and regularly during the study. Method of measurement: Termometer. ALT. Timepoint: At beginning and end of the study. Method of measurement: Intravenous blood test. AST. Timepoint: At beginning and end of the study. Method of measurement: Intravenous blood test. ALK. Timepoint: At beginning and end of the study. Method of measurement: Intravenous blood test. HomaPharmed Company Approved 2020-03-29 Baqiyatallah University of Medical Sciences Baqiyatallah University of Medical Sciences, Vanak square, Molasadra Ave Tehran Tehran Iran (Islamic Republic of)