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IRCT20200408046990N1 IRCT 2020-04-18 Mashhad University of Medical Sciences Evaluation of SinaCurcumin capsule efficacy as an supplement therapy for mild to moderate COVID-19 in Mashhad Evaluation of SinaCurcumin as a complementary therapy in mild to moderate COVID-19: An open label non-randomized clinical trial 2020-05-19 anticipated 60 Complete https://irct.ir/trial/47061 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 COVID-19 pneumonia. Intervention 1: Intervention group: nanocurcumin capsule 40mg, two capsule twice daily for two weeks then 1 capsule twice daily for 2 weeks. Intervention 2: Control group:all standard measures will be performed for patient. Yes - There is a plan to make this available What will be shared: The findings will be published in an article. Study protocol and statistical analysis will be used for article publication. When: One year after the end of the study it will be published and available in databases. To whom: If the funding sponsor allowed, the findings will be available for researchers, clinicians, and scientific centers. Conditions: The other researchers can use our findings in their review articles and meta analysis. Where to obtain: For this purpose, you can contact with Sepideh Elyasi, at Clinical Pharmacy Department, School of Pharmacy, Vakil Abad Aven., Mashhad, Iran. Email: elyasis@mums.ac.ir 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 Sepideh Elyasi
Vakilabad Boulevard; Ferdowsi University; Faculty of Pharmacy
Mashhad Iran (Islamic Republic of) 17871 91886 +98 51 3180 1588 elyasis@mums.ac.ir Mashhad University of Medical Sciences scientific Sepideh Elyasi
Faculty of Pharmacy, Ferdosi University, Vakilabad Aven.
Mashhad Iran (Islamic Republic of) 17871 91886 +98 51 3180 1588 elyasis@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) laboratory or radiologic or clinical diagnosis of mild to moderate COVID-19 age between 18-65y sign of the written consent Not simultaneous participating in other clinical trials 18 years 65 years Both more than 7d from the beginning of the symptoms pregnancy or lactation history of allergy to curcumin or turmeric smoking (more than 5 cigarettes per day) complicated concomitant bacterial infection adverse drug reaction occurrence SaO2<90% past medical diseases (e.g. kidney, hepatic, heart failure, complicated heart or brain disease, diabetes, chronic lung disease, malignancies, endocrine diseases, any immune system dysfunction like AIDS) history of gallbladder history of active GI ulcer U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Intervention group: nanocurcumin capsule 40mg, two capsule twice daily for two weeks then 1 capsule twice daily for 2 weeks Control group:all standard measures will be performed for patient. Fever. Timepoint: daily. Method of measurement: thermometer. Clinical response to treatment (including improvement of cough, myalgia, headache, Olfactory and taste disorders). Timepoint: daily. Method of measurement: Based on clinical, paraclinical and laboratory findings. Drug adverse reaction. Timepoint: daily. Method of measurement: patient interview and file. Radiologic response. Timepoint: one month after the beginning of the treatment. Method of measurement: lung HRCT. Length of hospital stay. Timepoint: at the end of treatment course. Method of measurement: patient file. Patient clinical outcome. Timepoint: at the end of the treatment. Method of measurement: patient file. Exir Nano Sina Pharmaceutical Company Mashhad University of Medical Sciences Exir Nano Sina Pharmaceutical Company Approved 2020-04-08 Ethics committee of Mashhad University of Medical Sciences Daneshgah street; Qureshi Building Mashhad Razavi Khorasan Iran (Islamic Republic of)