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IRCT20110907007511N4 IRCT 2020-07-25 Gorgan University of Medical Sciences Effect of Lavender syrup on COVID-19 Investigating the effect of Lavender (Lavandula angustifolia L.) syrup on improving the severity of cough in patients with definite or highly suspicious COVID-19 2020-05-16 anticipated 30 Complete https://irct.ir/trial/48013 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Fall criteria: - Sensitivity to lavender - Lack of proper use of prescribed drugs (less than 80%) - Drug side effects - Exacerbation of symptoms and the need for hospitalization, Randomization description: Randomization: According to the random list resulting from block randomization using blocks of size 4 is done. 3 Condition 1: COVID-19. Condition 2: COVID-19. Intervention 1: Intervention group: Supportive treatments related to the control of fever, pain, cough and other symptoms will be prescribed according to the common COVID-19 protocols in classical medicine. Also, in the intervention group receive 9 mL of lavender syrup twice a day for 14 days in addition to routine treatments (18 mL daily). Lavender syrup is prepared as follows:100 g of dried lavender branch (Lavandula angustifolia L.) is washed, then soaked in 1000 mL of water for 3 hours. It is then boiled for 10 min and the resulting liquid is cooled in the laboratory. After cooling, the contents of the container are concentrated with a smooth filter and the resulting product is concentrated. From the obtained dry extract, we make 5 g to 100 g using the USP syrup making model with 66.7 g of honey and 28.5 g of water. The resulting syrup is poured into 120 mL sterile jars, sealed and sterilized by autoclave. Intervention 2: Control group:Supportive treatments related to the control of fever, pain, cough and other symptoms will be prescribed according to the common COVID-19 protocols in classical medicine. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Dr. Marzieh Qaraati
Shastkola Road
Gorgan Iran (Islamic Republic of) 14395-477 +98 17 3245 1434 Dr.qaraati@goums.ac.ir Gorgan University of Medical Sciences scientific Marzieh Qaraati
Shastkola Road
gorgan Iran (Islamic Republic of) 14395-477 +98 17 3245 1434 Dr.qaraati@goums.ac.ir Gorgan University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 65 years Conscious consent to participate in the study Fever greater than 38 degrees or a feeling of hot flashes with at least one clinical sign of a dry cough, 24% number of breaths per minute, headache or body aches, feeling weak and lethargic, anosmia (olfactory disturbance) or taste disturbances, nausea Seven days or less after the onset of symptoms at the first visit or relapse within 6 weeks of previous treatment Absence of respiratory distress Candidate for outpatient treatment 18 years 65 years Both Need to be hospitalized Pregnancy and lactation Smoking Underlying heart / liver /kidney disease / high blood pressure Use other herbal medicines to control the symptoms of the disease Sensitivity to lavender U07.1 U07.2 COVID-19, virus identified COVID-19, virus not identified Treatment - Drugs Treatment - Drugs Intervention group: Supportive treatments related to the control of fever, pain, cough and other symptoms will be prescribed according to the common COVID-19 protocols in classical medicine. Also, in the intervention group receive 9 mL of lavender syrup twice a day for 14 days in addition to routine treatments (18 mL daily). Lavender syrup is prepared as follows:100 g of dried lavender branch (Lavandula angustifolia L.) is washed, then soaked in 1000 mL of water for 3 hours. It is then boiled for 10 min and the resulting liquid is cooled in the laboratory. After cooling, the contents of the container are concentrated with a smooth filter and the resulting product is concentrated. From the obtained dry extract, we make 5 g to 100 g using the USP syrup making model with 66.7 g of honey and 28.5 g of water. The resulting syrup is poured into 120 mL sterile jars, sealed and sterilized by autoclave. Control group:Supportive treatments related to the control of fever, pain, cough and other symptoms will be prescribed according to the common COVID-19 protocols in classical medicine. Changes in the severity of cough. Timepoint: Follow-up of patients in zero step (at the beginning of the study as a face-to-face visit), the first step (7 days after entering the study by telephone follow-up), the second step (14 days after entering the study by telephone follow-up), the third time (21 days after entering the study by telephone follow-up), the fourth time (14 days after the end of the study by telephone follow-up) and the fifth time (28 days after the end of the study by telephone follow-up). Method of measurement: Checklist of patient and disease characteristics, satisfaction with treatment by asking general questions, assessment of patient symptoms based on Visual Analogue Scale (10 points). Changes in the severity of fever. Timepoint: Follow-up of patients in zero step (at the beginning of the study as a face-to-face visit), the first step (7 days after entering the study by telephone follow-up), the second step (14 days after entering the study by telephone follow-up), the third time (21 days after entering the study by telephone follow-up), the fourth time (14 days after the end of the study by telephone follow-up) and the fifth time (28 days after the end of the study by telephone follow-up). Method of measurement: Checklist of patient and disease characteristics, satisfaction with treatment by asking general questions, assessment of patient symptoms based on Visual Analogue Scale (10 points). Change in the severity of shortness of breath. Timepoint: Follow-up of patients in zero step (at the beginning of the study as a face-to-face visit), the first step (7 days after entering the study by telephone follow-up), the second step (14 days after entering the study by telephone follow-up), the third time (21 days after entering the study by telephone follow-up), the fourth time (14 days after the end of the study by telephone follow-up) and the fifth time (28 days after the end of the study by telephone follow-up). Method of measurement: Checklist of patient and disease characteristics, satisfaction with treatment by asking general questions, assessment of patient symptoms based on Visual Analogue Scale (10 points). Quality of Life. Timepoint: Follow-up of patients in zero step (at the beginning of the study as a face-to-face visit), the first step (7 days after entering the study by telephone follow-up), the second step (14 days after entering the study by telephone follow-up), the third time (21 days after entering the study by telephone follow-up), the fourth time (14 days after the end of the study by telephone follow-up) and the fifth time (28 days after the end of the study by telephone follow-up). Method of measurement: Short questionnaire 12 questions SF12. Satisfaction with treatment. Timepoint: Follow-up of patients in zero step (at the beginning of the study as a face-to-face visit), the first step (7 days after entering the study by telephone follow-up), the second step (14 days after entering the study by telephone follow-up), the third time (21 days after entering the study by telephone follow-up), the fourth time (14 days after the end of the study by telephone follow-up) and the fifth time (28 days after the end of the study by telephone follow-up). Method of measurement: Asking general questions. Anxiety. Timepoint: Follow-up of patients in zero step (at the beginning of the study as a face-to-face visit), the first step (7 days after entering the study by telephone follow-up), the second step (14 days after entering the study by telephone follow-up), the third time (21 days after entering the study by telephone follow-up), the fourth time (14 days after the end of the study by telephone follow-up) and the fifth time (28 days after the end of the study by telephone follow-up). Method of measurement: Based on the Hamilton Questionnaire. Gorgan University of Medical Sciences Approved 2020-05-03 Ethics Committee of Golestan University of Medical Sciences Shadravan Falsafi Higher Education Complex; at the beginning of Shast Kola road Gorgan Golestan Iran (Islamic Republic of)