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IRCT20180712040449N2 IRCT 2020-04-01 Tehran University of Medical Sciences Effect of oral multi-herbal preparation on COVID-19 Formulation and evaluation of their efficacy of herbal capsule and decoction in patients with COVID-19 via a randomized clinical trial. 2020-03-23 anticipated 68 Complete https://irct.ir/trial/46782 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: To randomly assign the patients to two groups of treatment and placebo by a third person and using a computer program with simple randomization method, the random sample number is generated and each patient will be assigned a number. 3 COVID-19. Intervention 1: Intervention group: 34 patients receive herbal treatment including 150 ml of decoction (Matricaria chamomilla L., Zataria multiflora Boiss., Glycyrrhiza glabra L., Ziziphus jujuba Mill., Ficus carica L., Urtica dioica L., Althaea officinalis L., Hyssopus officinali L.) 3 times a day and capsule (Lyophilized powder from hydroalcoholic 70% extracts of Punica granatum L., Rheum palmatum L. and seed powder of Nigella sativa L.) 2 times a day with routine interventions based on the instructions of the Ministry of Health for 2 weeks. Intervention 2: Control group:34 patients receive routine interventions according to the instructions of the Ministry of Health for 2 weeks. Yes - There is a plan to make this available What will be shared: The documentation including the primary and secondary outcomes of patients that will be available When: From the start of the clinical study to one year after the completion of the clinical study To whom: If another researcher wants to perform a clinical study in this field and needs our information to do the study, the information will be provided with confidentiality. - If patients have side effects, and their doctors need the treatment information. -If a health authority's health policy requires our study information, then the information is provided with confidentiality. Conditions: If the applicant is authenticated, his request will be discussed with other researchers involved in the study, and the result will be informed to him. Where to obtain: Mehrdad Karimi mehrdadkarimi@yahoo.com 0098 21 66976527 How to obtain: At first, the applicants must send their request to the correspond author of the study, whose email address is on the IRCT site, and after verifying the applicant's identity, including one of the upon items, the correspond author requests information of the researchers who are present in the study and is sent to applicants. This period, after the applicant's authentication, will take about two weeks. Comments:
public Mehrdad Karimi
No. 27, Sarparast Ave, Taleghani Ave, Tehran, School of Persian medicine
Tehran Iran (Islamic Republic of) 1419814171 +98 21 8897 6527 mehrdadkarimi@yahoo.com Tehran University of Medical Sciences scientific Mehrdad Karimi
No. 27, Sarparast Ave, Taleghani Ave, Tehran, School of Persian medicine
Tehran Iran (Islamic Republic of) 1419814171 +98 21 8897 6527 mehrdadkarimi@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with one or more of the following symptoms in addition to acute respiratory disease (ARI):• RR> 30• PO2 <93%• Pulmonary infiltration in chest x-ray• Clinical judgment of a specialist Age range of 18 to 75 years in both genders Lack of any serious concomitant disease of the heart, brain, or lungs, metabolic disorders, and etc. The patient’s ability and own will to fill out a personal consent form for inclusion in the study Patient not intubated. 18 years 75 years Both Pregnancy and lactation Any history of allergy to any of the herbal product components Inability to take a drug per-oral Any condition that precludes continuance of medical intervention based on the judgment of a physician. Need for intubation Nausea and vomiting and oral intolerance Resistant hypoxemia Reduced level of consciousness Hemodynamic instability Hypercapnia - respiratory fatigue Any manifestation of known side effects of any of the herbal product components U07.1 Covid-19 Treatment - Drugs Treatment - Drugs Intervention group: 34 patients receive herbal treatment including 150 ml of decoction (Matricaria chamomilla L., Zataria multiflora Boiss., Glycyrrhiza glabra L., Ziziphus jujuba Mill., Ficus carica L., Urtica dioica L., Althaea officinalis L., Hyssopus officinali L.) 3 times a day and capsule (Lyophilized powder from hydroalcoholic 70% extracts of Punica granatum L., Rheum palmatum L. and seed powder of Nigella sativa L.) 2 times a day with routine interventions based on the instructions of the Ministry of Health for 2 weeks. Control group:34 patients receive routine interventions according to the instructions of the Ministry of Health for 2 weeks. O2 saturation percentage. Timepoint: Clinical examination and pulse oximetry at baseline, days 3, 6, 9, 12 and 14. Method of measurement: Pulse Oximeter. Lung inflammation. Timepoint: CT scan at baseline, days 7 and 14. Method of measurement: CT scan. Tehran University of Medical Sciences Approved 2020-03-22 Vice-Chancellor in Research Affairs of Tehran University of Medical Sciences Vice-Chancellor in Research Affairs of Tehran University of Medical Sciences, Ghods Ave, Keshavarz Blvd, Tehran Tehran Tehran Iran (Islamic Republic of)