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IRCT20200316046792N1 IRCT 2020-03-17 Iran University of Medical Sciences Effect of herbal syrup and solution in treatment of COVID-19 Formulation of two natural products (syrup and solution) and evaluation of their effects in patients with coronavirus disease 2019 (COVID-19): A randomized controlled trial 2020-03-16 anticipated 150 Complete https://irct.ir/trial/46554 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomized in a 1:1 ratio into one of the treatment groups and standard of care group using computer generated randomization plan. The date and time of randomization will be recorded. Allocation concealment will be done with the sealed envelope method, Blinding description: The treatment assignment will remain unknown until the patient is randomized. Physicians who treat patients and the patients will not be blinded. Radiologists, physicians who assess outcomes and the statistician analyzing the data all will be blinded. 2-3 COVID-19. Intervention 1: Intervention group: Hospitalized patients will receive 10 cc Corostop solution and 30 cc Coroguard syrup three times daily for 10 days in addition to receiving standard treatments recommended by the corona county committee. Intervention 2: Control group: Hospitalized patients will receive standard treatment according to the national guidelines for the treatment of COVID-19. Intervention 3: Intervention group: Outpatients (self-quarantine at their home) will receive 10 cc Corostop solution and 30 cc Coroguard syrup three times daily for 10 days in addition to receiving standard treatments recommended by the corona county committee. Yes - There is a plan to make this available What will be shared: The study results will be published. Also the study protocol and statistical analysis will be considered. When: One year after completion of the study, data will be published and available To whom: With the financial backing permission, data may be made available to the physicians and academic researchers and institutions. Conditions: Other researchers are permitted to included the results in their systematic reviews and metaanalysis Where to obtain: For this you may ask Amirhossein Janshidi through jamshidiam@yahoo.com How to obtain: After receiving the query, dependent on the requested data, the scientific responsible person of the study will response to the query in coordinate with the sponsor within 2 weeks Comments:
public Amir Hossein Jamshidi
No 847, Behesht St. South Side of Shahr Park, Vahdat-e-Islami St., Hasan Abad Sq., Tehran, Iran
Tehran Iran (Islamic Republic of) 1114733311 +98 21 5563 9666 jamshidi.ah@iums.ac.ir Iran University of Medical Sciences scientific Amir Hossein Jamshidi
No 847, Behesht St. South Side of Shahr Park, Vahdat-e-Islami St., Hasan Abad Sq., Tehran, Iran
Tehran Iran (Islamic Republic of) 1114733311 +98 21 5563 9666 jamshidi.ah@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Laboratory-confirmed COVID-19 cases (2019-nCoV Real-Time RT-PCR ), regardless of the clinical manifestations and history of close contact Both the men and women, aged between 18 to 65 years old Signing informed written consent Highly suspected cases of COVID-19 based on positive findings of chest CT scan 18 years 65 years Both 5 days or more after the onset of illness Pregnancy Breastfeeding History of drug allergy Complicated cases with bacterial infection Patients in recovery phase Critical and severe cases such as ARDS Clinical evidence for respiratory insufficiency at the time of hospitalization (SaO2 ≤90% or PaO2 < 8 kPa) in the patient breathing room air without oxygen therapy Comorbidities (e.g. renal failure, liver failure, CHF, cerebrovascular and cardiovascular major diseases, chronic pulmonary disease, malignancy, endocrine and metabolic diseases, any immunodeficiency disorders such as AIDS, encephalopathy, neuropathy ) U07.1 COVID-19 Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Hospitalized patients will receive 10 cc Corostop solution and 30 cc Coroguard syrup three times daily for 10 days in addition to receiving standard treatments recommended by the corona county committee. Control group: Hospitalized patients will receive standard treatment according to the national guidelines for the treatment of COVID-19 Intervention group: Outpatients (self-quarantine at their home) will receive 10 cc Corostop solution and 30 cc Coroguard syrup three times daily for 10 days in addition to receiving standard treatments recommended by the corona county committee. Response to the treatment (Significant clinical improvement). Timepoint: At baseline and on the third, fifth, seventh, and tenth days after starting the treatment. Method of measurement: According to the clinical, paraclinical and laboratory findings. Clinical improvement: normalization of the body temperature (≤37.2 ° C), respiratory rate (≤24 breaths per minute), oxygen saturation (> 94% at room temperature) and cough (zero or mild) that persist for at least 24 hours. Cough will measure on a qualitative scale based on the patient's report . Other outcome variables will measure during clinical examination. Complications of the treatment. Timepoint: Daily, until the tenth day. Method of measurement: Interview and patient's record. Duration of hospitalization. Timepoint: End of the treatment. Method of measurement: Patient's medical record. Mortality. Timepoint: End of the treatment. Method of measurement: Patient's medical record (Clinical outcome). Iran University of Medical Sciences Approved 2020-03-16 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, 1449614535, Iran Tehran Tehran Iran (Islamic Republic of)