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IRCT20201220049771N1 IRCT 2020-12-31 Shahid Beheshti University of Medical Sciences study of the effectiveness of "SALIRAVIRA" as a natural product on the treatment of COVID-19 patients Study of the effectiveness of "SALIRAVIRA" as a natural product containing Licorice, Cone flower, Ginseng, Hyssop, Rhubarb and Rosemary extracts on the recovery of COVID-19 patients 2020-12-21 anticipated 120 Complete https://irct.ir/trial/53131 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants will be assigned to two groups by block randomization method. In order to minimize the probability of sequence prediction, blocks with variable (4 and 6) size will be used. The randomization ratio will be 1:1. Randomization will be done using Random allocation software. Allocation concealment will be done by assigning unique codes. N/A COVID-19. Intervention 1: Intervention group: Patients who receiving "SALIRAVIRA" containing mentioned extracts orally and respiratory spray at the same time in addition to standard treatments of COVID-19: 1- Oral; SALIRAVIRA tablet 750 mg; containing 500 mg of plant extracts mentioned before; 4 times daily, Once every 6 hours (tablets are packed in blisters contain 10 tablet and will be provided to each case for the duration of treatment, ie 32 tablet) All process of extraction, production and packaging done under GMP conditions in Mimdaroo pharmaceutical company. 2 - SALIRAVIRA respiratory spray (20ml), which contains plant extracts mentioned before will be used 4 times daily, once every 6 hours, spay will be used nasal or throat along with tablets. SALIRAVIRA spray contains 100mcl of plant extract per puff and its daily dose is 400 mcl based on references. All stages of production and packaging of SALIRAVIRA spray have been done under GMP conditions and in Mimdaroo Pharmaceutical company. The duration of treatment will be 8 days. Intervention 2: Control group: Patients receiving standard treatments for COVID-19 disease for 8 days. Standard treatment is determined according to the protocols and guidelines of the Ministry of Health and is performed in all centers. Yes - There is a plan to make this available What will be shared: Data can be shared after de-identification When: Data will be available from April, 2030 To whom: Academics employed at various research/university institutions and the industry. Conditions: Using the de-identified data will be allow for scientific research by academics, including faculty members and students. In this case, by sending the request and reviewing it, the requested data will be provided. Where to obtain: At first should refer to a person responsible for general inquiries of the clinical trial and then to the principal investigator. How to obtain: 1- The applicant would be asked to provide a written formal request letter, containing the importance of the data . 2- Following the receipt of request letter, the data would be provided in no more than one week. Comments:
public Saleh Ramezani Khorshiddoust
No. 04, 4th alley, Ghanbarzadeh St. Shahid Beheshti St., Tehran, Iran
tehran Iran (Islamic Republic of) 1533853613 +98 21 9662 1410 Saleh.rkh@gmail.com MimDaroo Pharmaceutical Co. scientific Tahereh Hosseinabadi
No.2660, Vali-asr Ave., Shahid Beheshti School of Pharmacy
tehran Iran (Islamic Republic of) 1996835113 +98 21 8820 0118 hosseinabadi.t@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Clinical confirmation of coronavirus infection COVID-19 positive test reporting by RT-PCR Cases with contact history with a COVID-19 patients in last 10 days Lung involvement below 20% - Using CT-Scan 12 years 80 years Both Pregnancy and Lactation cases Cases with malignant tumors and other acute systemic diseases or special indication Patients suffering from autoimmune diseases like Psoriasis, ALS and MS Patients with comorbidity of respiratory life-threatening problems Addiction to drugs and alcohol Participation to another clinical trial for COVID-19 U07.1 COVID-19 virus identified Treatment - Drugs Treatment - Drugs Intervention group: Patients who receiving "SALIRAVIRA" containing mentioned extracts orally and respiratory spray at the same time in addition to standard treatments of COVID-19: 1- Oral; SALIRAVIRA tablet 750 mg; containing 500 mg of plant extracts mentioned before; 4 times daily, Once every 6 hours (tablets are packed in blisters contain 10 tablet and will be provided to each case for the duration of treatment, ie 32 tablet) All process of extraction, production and packaging done under GMP conditions in Mimdaroo pharmaceutical company. 2 - SALIRAVIRA respiratory spray (20ml), which contains plant extracts mentioned before will be used 4 times daily, once every 6 hours, spay will be used nasal or throat along with tablets. SALIRAVIRA spray contains 100mcl of plant extract per puff and its daily dose is 400 mcl based on references. All stages of production and packaging of SALIRAVIRA spray have been done under GMP conditions and in Mimdaroo Pharmaceutical company. The duration of treatment will be 8 days. Control group: Patients receiving standard treatments for COVID-19 disease for 8 days. Standard treatment is determined according to the protocols and guidelines of the Ministry of Health and is performed in all centers. Viral Clearance. Timepoint: At the beginning of the study and and 4, 8 days after intake. Method of measurement: Polymerase chain reaction (PCR). Fever and symptoms. Timepoint: At the beginning of the study and daily during treatment after intake. Method of measurement: Using a thermometer and clinical diagnosis. Shortness of breath. Timepoint: At the beginning of the study and daily during treatment after intake. Method of measurement: Medical diagnosis. Olfactory (sense of smell). Timepoint: At the beginning of the study and daily during treatment after intake. Method of measurement: Questionnaire with interview. Sense of taste. Timepoint: At the beginning of the study and daily during treatment after intake. Method of measurement: Questionnaire with interview. MimDaroo Pharmaceutical Company Approved 2020-12-13 Ethics committee of School of Pharmacy and Nursing & Midwifery - Shahid Beheshti University of Medic NO 2660, Vali-asr Ave, Tehran Tehran Tehran Iran (Islamic Republic of)