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IRCT20200611047735N1 IRCT 2020-06-19 Bandare-abbas University of Medical Sciences Evaluation of the effect of nano micelles containing curcumin (Sina Ccurcumin) as a therapeutic supplement in patients with COVID-19 Evaluation of the effect of nano micelles containing curcumin (Sina Ccurcumin) as a therapeutic supplement in patients with COVID-19 and investigating of immune responses balance changes following treatment: A randomized double blind clinical trial. 2020-07-05 anticipated 40 Complete https://irct.ir/trial/48843 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method in this study is used as an individual randomization using a sealed sealed envelope randomization tool. In this case, the third person was responsible for picking up and selecting the envelopes as a random arrangement in which the placebo and the main drug were randomly divided among the patients. The study person and the analyst will not be aware of how the randomization happened, Blinding description: In order to perform the blinding, according to the number of patients, the nanocurcumin and placebo, which are quite similar in shape and characteristics, is randomly placed in the same boxes and the boxes are coded. The codes related to the drug and placebo will be provided by a third party, and the therapist, patient, data collector, and analyzer will not be notified, and the boxes will be given to patients upon arrival. . N/A COVID-19. Intervention 1: Intervention group: Patients with COVID-19, in addition to routine drug treatment, will receive 40 mg of nano curcumin capsules 4 times a day (one for breakfast, one for lunch, one for dinner and one before bedtime) for 2 weeks. Intervention 2: Control group: COVID-19 patients will receive 4 placebo a day (after breakfast, lunch and dinner one and one before bedtime) for 2 weeks in addition to routine medication. Yes - There is a plan to make this available What will be shared: After extraction, the data will be analyzed for presentation as a scientific paper and report. When: After the study, it is possible to access To whom: There are no restrictions on access. Conditions: The rights to use the project are reserved. If there is a request to access the data, it will be done with the opinion of the correspondence of the present project and the type of use of the data will be according to the opinion of the correspondence of the present project. Where to obtain: Correspondence with correspondence of the present project. How to obtain: In order to access the data, it will be decided by correspondence of the present project. Comments:
public Amin Reza Nikpoo
Immunology Department, School of Medicine, Imam-Hussein Blvd
Bandar Abbas Iran (Islamic Republic of) 7919693116 +98 76 3371 0370 nikpoora@hums.ac.ir Bandare-abbas University of Medical Sciences scientific Amin Reza Nikpoor
Immunology Department, School of Medicine, Imam-Hussein Blvd
Bandar Abbas Iran (Islamic Republic of) 7919693116 +98 76 3371 0370 nikpoora@hums.ac.ir Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Laboratory-approved COVID-19 tests (2019-nCoV Real-Time RT-PCR) (preferably at a particular center or university-approved center) regardless of clinical manifestations and close contact history Signing a written consent form No simultaneous participation in other clinical trials 18 years 75 years Both Pregnancy and lactation History of allergy to turmeric or curcumin products Smoking (more than 5 cigarettes a day) Patient connected to the ventilator Clinical evidence for respiratory failure at the time of hospitalization / admission (SaO2 ≤ 90% or PaO2 <8 kPa) Having comorbidities (such as severe renal failure Glomerular filtration rate less than 30 ml / min, liver failure ,Congestive heart failure, or Chronic obstructive pulmonary disease) History of gallstones History of gastritis or active gastrointestinal ulcer • U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Intervention group: Patients with COVID-19, in addition to routine drug treatment, will receive 40 mg of nano curcumin capsules 4 times a day (one for breakfast, one for lunch, one for dinner and one before bedtime) for 2 weeks. Control group: COVID-19 patients will receive 4 placebo a day (after breakfast, lunch and dinner one and one before bedtime) for 2 weeks in addition to routine medication. Clinical symptoms. Timepoint: On a weekly basis, patients are examined clinically on days 1, 7, and 14. Method of measurement: Clinical examinations. Immune cell balance. Timepoint: On a weekly basis, blood samples are taken from patients and patients are examined on days 1, 7 and 14. Method of measurement: Molecular experiments. Bandare-abbas University of Medical Sciences Approved 2020-06-10 Ethics committee of Hormozgan University of Medical Sciences Imam Hussain Blvd, School of Medicine, Immunology Department Bandar Abbas Hormozgan Iran (Islamic Republic of)