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IRCT20211108053002N1 IRCT 2021-11-21 Rafsanjan University of Medical Sciences Evaluation of the effect of plant compounds extract (including aqueous extract of Ador-Cancer, saffron petals and mountain tea) in patients with coronary disease Evaluation of the effects of the aqueous extract of Alhagi papilionaceae or petals Saffron petal and mountain tea herbs on the clinical and paraclinical symptoms of COVID-19 patients 2021-12-22 anticipated 40 Complete https://irct.ir/trial/59899 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method and description: Simple randomization Randomization unit: individual Randomization tool: Excel software How to build a random sequence: Using the Excel Rand function Hide: In order to hide random allocation, the method of SNOSE will be used, Blinding description: Thus, drug and placebo syrups will be prepared in one form and one form and will be prescribed to patients by the doctor. Syrups have codes that neither the doctor nor the researcher knows about. Also, data collection is done by a researcher who does not know the divided group. In addition, the people who will analyze the data will be unaware of the content of the groups. Thus, neither the patient, nor the researcher, nor the physician, nor the data analyst will know the content of the groups. Patients are also asked not to talk about their treatment with other patients. The patient code will be opened only in emergency situations and when the possible side effects of taking the drug make it necessary to change the treatment protocol. Data entry software will be locked so data access or change will not be possible. Monitoring and control An independent supervisor will be asked to check all questionnaires and make sure the consent forms are signed. Also, a number of patients will be randomly selected and asked about the treatment protocol. 2 symptoms of COVID-19 patients. Intervention 1: Intervention group: Patients with Covid-19 will consume 10 ml of syrup containing aqueous extracts of Ador-Cancer, saffron petals and mountain tea 3 times a day. In this study, no special equipment is used and the explanations of this trial are given in printed form to the volunteers. Entry to this study does not require special training. Herbal extract syrup is prepared and approved in Rafsanjan University of Medical Sciences. Intervention 2: Control group: Control group: Yamaran with Covid-19 will take 10 ml of placebo 3 times a day. In this study, no special equipment is used and the explanations of this trial are given in printed form to the volunteers. Entry to this study does not require special training. The placebo is prepared and approved at Rafsanjan University of Medical Sciences. Yes - There is a plan to make this available What will be shared: Part of the data, such as information about the main outcome, can be shared. When: After the publication of the article, all data will be available to all researchers indefinitely To whom: Everyone Conditions: For research work Where to obtain: Refer to the project manager and send an email Dr. Ali Darreh Kurdi adarehkordi@yahoo.com How to obtain: Formal request to the university and then refer to the project manager Comments:
public Ali Drehkordi
Pistachio Boulevard
rafsanjan Iran (Islamic Republic of) 7718175911 +98 913 290 6232 mojgan.noroozi@yahoo.com Rafsanjan University of Medical Sciences scientific ali darekordi
Pistachio Boulevard
rafsanjan Iran (Islamic Republic of) 7718175911 +98 34 3131 5000 mojgan.noroozi@yahoo.com Rafsanjan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria in this study include all patients who have been diagnosed with Covid 19 infection and do not have other infections or diseases such as influenza, pulmonary insufficiency, ARDS pneumonia and other cold symptoms, as well as files with complete data. Consciously taken from patients. no limit no limit Both Exclusion criteria included patients who had other infections or diseases such as influenza, pulmonary insufficiency, ARDS pneumonia and other cold symptoms and the result of Qovid 19 infection is negative. Also, files with incomplete data will be removed from this study. Obviously, conscious dissatisfaction also leads to exclusion from the study. Patients who were hospitalized and their clinical condition was deteriorating were excluded from the study and lung CT scans were obtained from patients. Patients with oxygen levels less than 93 mm Hg were excluded from the study U07.1 COVID-19, virus identified Treatment - Drugs Placebo Intervention group: Patients with Covid-19 will consume 10 ml of syrup containing aqueous extracts of Ador-Cancer, saffron petals and mountain tea 3 times a day. In this study, no special equipment is used and the explanations of this trial are given in printed form to the volunteers. Entry to this study does not require special training. Herbal extract syrup is prepared and approved in Rafsanjan University of Medical Sciences. Control group: Control group: Yamaran with Covid-19 will take 10 ml of placebo 3 times a day. In this study, no special equipment is used and the explanations of this trial are given in printed form to the volunteers. Entry to this study does not require special training. The placebo is prepared and approved at Rafsanjan University of Medical Sciences. The length of hospitalization of patients with Covid-19. Timepoint: 21 days after starting of intervention. Method of measurement: By referring to the patient's medical record. The mortality in patients with Covid-19. Timepoint: 21 days after starting of intervention. Method of measurement: By referring to the patient's medical record. The pulmonary infiltration in patients with Covid-19. Timepoint: 7, 14 and 21 days after starting of intervention. Method of measurement: With CT scan. Side effects from the use of herbal compounds (COVID-herbs). Timepoint: 7, 14 and 21 days after starting of intervention. Method of measurement: Refer to the medical file and complete a special questionnaire for complications. The liver function in patients with Covid-19. Timepoint: 7, 14 and 21 days after starting of intervention. Method of measurement: Evaluation of SGOT and SGPT enzymes using ELISA kit. The kidney function in patients with Covid-19. Timepoint: 7, 14 and 21 days after starting of intervention. Method of measurement: Evaluation of chemical parameters such as BUN and Creatinine by colorimetric method with autoanalyzer. Rafsanjan University of Medical Sciences Approved 2021-06-19 Ethics Committee of University of Medical Sciences Persian Gulf Boulevard - Pistachio Boulevard - Campus of Molecular Medical Research Center rafsanjan Kerman Iran (Islamic Republic of)