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IRCT20200518047497N1 IRCT 2020-05-21 Tabriz University of Medical Sciences Effect of Laris - Hyssop combined herbal distilled on the improving clinical and paraclinical symptoms in patients with COVID-19 Effect of Laris - Hyssop combined herbal distilled on the improving clinical and paraclinical symptoms in patients with COVID-19: A Randomized Controlled Trial 2020-05-25 anticipated 80 Complete https://irct.ir/trial/48289 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be allocated to trial groups (intervention and placebo groups) randomly using Random Allocation Software (RAS) trough random block sizes of 4 and 6 with an allocation ratio of 1:1. Patients will receive a sealed bottle containing Laris-Hyssop distillate or placebo by giving 10 ml every 8 hours for 14 days. Random sequencing allocation will be produced by the person who has not to participate in the research. Bottles will be numbered from 1 to 80 according to the sequence generated. Both groups will receive routine treatments, Blinding description: This study is a randomized controlled triple blinded trial, meaning that the patients, researcher, and statistical analyst will be blind to the received active drug or placebo. Random sequencing allocation will be produced by the person who has not to participate in the research. Each participant will receive a sealed bottle containing Laris-Hyssop distillate or placebo by giving 10 ml every 8 hours for 14 days. N/A COVID-19. Intervention 1: Intervention group: In the intervention group, participants will receive Laris-Hyssop distillate (including hyssop, Echium amoenum, Adiantum capillus-veneris, Hollyhocks, Eucalyptus, Malva, Platanus, chamomilla), 10 ml every 8 hours for 14 days orally. Both groups will receive routine treatments. Intervention 2: Control group: The control group will receive a placebo (no therapeutic value), resembled the Laris-Hyssop distillate with the same prescription. Both groups will receive routine treatments. Yes - There is a plan to make this available What will be shared: The effects of Laris-Hyssop distillate on improving clinical and paraclinical symptoms of COVID-19 patients When: End of July To whom: healthcare professional- Professors Conditions: An official request from the organization Where to obtain: Tabriz University of Medical Sciences How to obtain: Request to Vice-Chancellor for Research and Technology Affairs Comments:
public Javad Ahmadian heris
Sheshgelan, Tabriz, East Azerbaijan Province
Tabriz Iran (Islamic Republic of) 5136735886 +98 41 3526 2280 Jahmadian75@gmail.com Tabriz University of Medical Sciences scientific Javad Ahmadian heris
Sheshgelan, Tabriz, East Azerbaijan Province
Tabriz Iran (Islamic Republic of) 5136735886 +98 41 3526 2280 Jahmadian75@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) COVID-19 patients aged 15 years and older Newly admitted people (first day of hospitalization) Obtaining informed consent to participate in the trial Non-participation in another clinical trial simultaneously 15 years no limit Both Epilepsy Having liver or kidney failure according to the patient's statement, and doctor examination or based on creatinine, SGOT, SGPT, LDH tests. Having a chronic disease (cardiovascular disease, uncontrolled high blood pressure (hypertension above 160/100 despite taking medication), complicating diabetes, respiratory diseases, BMI> 40 according to the patient's statement, and doctor examination Immunodeficiency (treated with Corticosteroids over 12.5 mg / d Prednisolone for more than two weeks, chemotherapy, malignancies, organ transplants, HIV patients, other viral diseases) Pregnancy (according to the patient's statement and examination by a doctor) Breastfeeding (according to the patient's statement) U07.01 Novel Cronavirus Disease (COVID-19) Treatment - Drugs Placebo Intervention group: In the intervention group, participants will receive Laris-Hyssop distillate (including hyssop, Echium amoenum, Adiantum capillus-veneris, Hollyhocks, Eucalyptus, Malva, Platanus, chamomilla), 10 ml every 8 hours for 14 days orally. Both groups will receive routine treatments. Control group: The control group will receive a placebo (no therapeutic value), resembled the Laris-Hyssop distillate with the same prescription. Both groups will receive routine treatments. Respiratory Rate. Timepoint: Daily. Method of measurement: Observation. Oxygen saturation (SpO2). Timepoint: Daily. Method of measurement: Pulse Oximeter. Serum White Blood Cell count. Timepoint: Before- After intervention (14 days). Method of measurement: laboratory cell counter. Serum CRP level. Timepoint: Before-After intervention (14 days). Method of measurement: Biochemical method. Number of inpatient days. Timepoint: After intervention. Method of measurement: Questionnaire. Mortality. Timepoint: Daily. Method of measurement: Questionnaire. The time of absence of dry Cough. Timepoint: Daily. Method of measurement: Daily symptom questionnaire. The time of absence of trembling. Timepoint: Daily. Method of measurement: Daily symptom questionnaire. The time of absence of sore throat. Timepoint: Daily. Method of measurement: Daily symptom questionnaire. The time of absence of difficulty breathing or shortness of breath. Timepoint: Daily. Method of measurement: Daily symptom questionnaire. The time of absence of temperature equal to or grater than 37/8 C. Timepoint: Daily. Method of measurement: Daily symptom questionnaire. Body temperature. Timepoint: Daily. Method of measurement: Thermometer. Negative unilateral infiltration. Timepoint: After intervention. Method of measurement: Radiography- CT SCAN. Negative bilateral infiltration. Timepoint: After intervention. Method of measurement: Radiography- CT SCAN. Tabriz University of Medical Sciences Approved 2020-04-13 Ethics Committee of Tabriz University of Medical Sciences No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)