The clinical effect of Nano micelles containing curcumin as a therapeutic supplement in patients with COVID-19 and the immune responses balance changes following treatment: A structured summary of a study protocol for a randomised controlled trial

This study is conducted as a prospective, placebo-controlled with parallel group, single-center randomized clinical trial on COVID-19 patients.ParticipantsPatients are selected from the COVID-19 ward of Shahid Mohammadi Hospital in Bandar Abbas, Iran.Inclusion criteria:1. Real time PCR-approved positive COVID-19 test.2. Both gender3. Age between 18 and 75 years4. Signing a written consent5. Lack of participation in other clinical trialsExclusion criteria:1. Pregnancy or lactation2. Allergy to turmeric or curcumin3. Smoking4. Patient connected to the ventilator5. SaO2 less than 90% or PaO2 less than 8 kPa6. 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)7. History of gallstones8. History of gastritis or active gastrointestinal ulcerIntervention and comparatorIn addition to the routine standard treatments for COVID-19, in the intervention group, 40mg nanomicelles containing curcumin (SinaCurcumin Capsule, Exir Nano Sina Company, Iran), four times per day (after breakfast, lunch, dinner and before bedtime) and in the placebo group as the control group, capsules with the same appearance and characteristics (Placebo capsules, Exir Nano Sina Company, Iran) are prescribed for two weeks.Main outcomesThe effectiveness of Nano micelles containing curcumin treatment will be evaluated as daily clinical examinations of patients in both groups and, on days ...
Source: Trials - Category: Research Source Type: clinical trials