Effects of pomegranate juice ( Punica Granatum ) on inflammatory biomarkers and complete blood count in patients with COVID-19: a structured summary of a study protocol for a randomized clinical trial

This study is conducted to investigate efficacy of pomegranate juice on inflammatory biomarkers, C-reactive protein (CRP), interleukin 6(IL-6), erythrocyte sedimentation rate (ESR) and complete blood count (CBC) in hospitalized patients with mild to moderate coronavirus disease 2019 (COVID- 19).Trial DesignThis is a randomized, placebo-controlled, double-blind, parallel 2-arm (1:1 ratio) clinical trial.ParticipantsPatients with COVID-19 admitted to hospitals in Yasuj City, Kohgiluyeh and Boyer-Ahmad Province, Iran.Inclusion CriteriaInformed consentPatients 18 years of age or olderDiagnosis of COVID-19 based on real-time polymerase chain reaction (RT-PCR) testExclusion CriteriaPregnancy or lactationImmunoglobulin A (IgA) level<61 mg/dlDisseminated intravascular coagulation or any other types of coagulopathySevere congestive heart failureParticipation in any clinical trial within 30 days prior to enrollment in this RCTOther contraindications determined by the specialist.Intervention and ComparatorIntervention: 500 ml pomegranate juice and standard of care hospital treatment for COVID-19Comparator: matching placebo containing 500 ml of red water and standard of care hospital treatment for COVID-19Both intervention and comparator to be taken twice a day, after lunch and dinner, for 14 days.Criteria for DiscontinuingTransfer of patients to intensive care unit (ICU)DeathUnwillingness to continue participating in the studyMain OutcomesThe main outcomes of this study are levels of...
Source: Trials - Category: Research Source Type: clinical trials