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.

Clinical study to investigate the effectiveness of curcumin-containing nanomaterials and its effects on immune cell balance as a therapeutic supplement in the treatment of COVID-19

Clinical trial with control groups using placebo with parallel group, double-blind, randomized trials will be performed on 40 COVID-19 patients which will be randomized using encoded sealed wax boxes.

Patients are selected from the COVID-19 ward of Shahid Mohammadi Hospital in Bandar Abbas. Patients who enter the study receive standard treatment with nanocurcumin or placebo within two weeks. the study is blinded by the therapist, patient, data collector, and analyzer through randomly encoded boxes. on days 1, 7, and 14 of the study, clinical history and blood samples are taken from patients.

Inclusion criteria: Laboratory-approved COVID-19 tests Both gender Age between 18 and 75 years Signing a written consent Lack of participation in other clinical trials ;Exclusion criteria Pregnancy and lactation Allergy to turmeric or curcumin Smoking Patient connected to the ventilator SaO2 less than 90% or PaO2 less than 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

In addition to the usual treatments, in the intervention group, 40mg nanocurcumin capsules 4 mg per day (after breakfast, lunch and dinner, one before bedtime) for 2 weeks, and in the placebo group, capsules with the same appearance are prescribed

Effectiveness of nano micelles containing curcumin as a complementary treatment in improving symptoms of patients with COVID-19 and examining changes in the immune cell balance

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.

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. .

After extraction, the data will be analyzed for presentation as a scientific paper and report.

After the study, it is possible to access

There are no restrictions on access.

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.

Correspondence with correspondence of the present project.

In order to access the data, it will be decided by correspondence of the present project.