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IRCT20200518047497N2 IRCT 2020-06-06 Zahravi Pharmaceutical Company Effect of Dinvl on improving of clinical and paraclinical symptoms in patients with COVID-19 Effect of Dinvl medicinal herb on improving of clinical and paraclinical symptoms in patients with COVID-19 :A Randomized Controlled Trial 2020-06-20 anticipated 80 Complete https://irct.ir/trial/48644 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 containers of Dinvl sublingual tablets 399 ± 5 mg containing 43.5 mg of herbal powder or placebo made by Zahravi Pharmaceutical Company of Tabriz. Two sublingual tablets will be taken every 6 hour for 7 days (a total of 56 tablets for each person) not simultaneously with other any medications. Random sequencing allocation will be produced by the person who has not to participate in the research. Containers 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-blind clinical trial. This means that patient, researcher, safety and data monitoring committee, clinical caregiver and statistical analyst will be blind to the received medication. Each person will be given a opaque matte container of medicine containing herbal tablets of Dinolol or placebo in the identical shape, weight, smell and color. 3 COVID-19. Intervention 1: Intervention group: In the intervention group, participants will receive Dinvl sublingual tablets 399±5 mg containing 43.5 mg of herbal powder made by Zahravi Pharmaceutical Company in Tabriz which will be taken every 6 hours for 7 days (a total of 56 tablets per person) not at the same time with other drugs. Both groups will receive routine treatments. Intervention 2: Control group: The control group will receive a placebo, resembled the Dinvl tablets with the same prescription. Both groups will receive routine treatments. Yes - There is a plan to make this available What will be shared: Effect of Dinvl medicinal herb on improving of clinical and paraclinical symptoms in patients with COVID-19 :A Randomized Controlled Trial When: End of august To whom: healthcare professional- َacademic members of universities 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 ahmadianj@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Javad Ahmadian Heris
Sheshgelan., Tabriz., East Azerbaijan Province
Tabriz Iran (Islamic Republic of) 5136735886 +98 41 3526 2280 ahmadianj@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) COVID-19 patients aged 15 years and older who newly admitted (first day of hospitalization) Having definite COVID-19 disease Obtaining informed consent to participate in the trial Non-participation in another clinical trial simultaneously 15 years no limit Both Epilepsy Having liver or renal failure according to the patient's statement, physician examination or based on creatinine, SGOT, SGPT, LDH tests. Immunodeficiency (treated with Corticosteroids over 12.5 mg / d Prednisolone for more than two weeks, chemotherapy, malignancies, organ transplants, HIV patients, other viral diseases. Having other infectious diseases according to the diagnosis of the physician and the information of medical record. Pregnancy (according to the patient's statement and examination by a physician). 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 Dinvl sublingual tablets 399±5 mg containing 43.5 mg of herbal powder made by Zahravi Pharmaceutical Company in Tabriz which will be taken every 6 hours for 7 days (a total of 56 tablets per person) not at the same time with other drugs. Both groups will receive routine treatments. Control group: The control group will receive a placebo, resembled the Dinvl tablets 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- 14 days after intervention. Method of measurement: Laboratory cell counter. Serum CRP level. Timepoint: Before- 14 days after intervention. Method of measurement: Biochemical method. ESR (Erythrocyte Sedimentation Rate). Timepoint: Before- 14 days after intervention. Method of measurement: Checking the sedimentation rate of erythrocytes in a special tube within one hour. Number of hospitalization 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 recording questionnaire. The time of absence of trembling. Timepoint: Daily. Method of measurement: Daily symptom recording questionnaire. The time of absence of sore throat. Timepoint: Daily. Method of measurement: Daily symptom recording questionnaire. The time of absence of dry Cough. Timepoint: Daily. Method of measurement: Daily symptom recording questionnaire. The time of absence of difficulty in breathing or shortness of breath. Timepoint: Daily. Method of measurement: Daily symptom recording questionnaire. The time of absence of temperature equal to or grater than 37.8 C. Timepoint: Daily. Method of measurement: Daily symptom recording questionnaire. Body temperature. Timepoint: Daily. Method of measurement: Thermometer. Side effects. Timepoint: Daily. Method of measurement: Side effects checklist. Zahravi Pharmaceutical Company Approved 2020-05-10 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)