Evaluation the Efficacy of CURCUDEN 35 in Patients with COVID-19

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2020
INTERVENTION: Intervention 1: Intervention group: Patients with covid‐19 who use curcumin in addition to first‐line drugs during treatment. Intervention group receive two capsules of CURCUDEN® every 12 hours in addition to the main treatment based on national guidelines for the treatment of hospitalized patients with COVID‐19. Curcuden 35 is a drug used by Alborz Nanomed tech Company. Intervention 2: Control group: Patients with covid‐19 who use placebo in addition to first‐line drugs during treatment. Control group receive two capsules of placebo every 12 hours in addition to the main treatment based on national guidelines for the treatment of hospitalized patients with COVID‐19. CONDITION: covid‐19 pneumonia Disease. ; covid‐19 pneumonia U07.1 INCLUSION CRITERIA: Virological diagnosis of SARS‐CoV‐2 infection by RT‐PCR Positive imaging findings: Condensation, Grand Glass opacity or bilateral pulmonary infiltration on CT scan or Chest X‐ray Need to get extra oxygen to maintain SO2> 94% or PaO2 / FiO2> 300 PRIMARY OUTCOME: 1‐ Evaluation of clinical variables involved in patients' recovery including mechanical ventilation. Timepoint: On days 1, 5 and 14 of the start of treatment. Method of measurement: Spirometry test. 10‐ Comparison of patients' CRP levels in treatment and control groups. Timepoint: On days 1, 5 and 14 of the start of treatment. Method of measurement: Blood biochemical test. 11‐ Length of improvement period of patients' lung imaging results and comparison of results intreatment and control groups. Timepoint: On days 1 and 5 of the start of treatment. Method of measurement: lung CT Scan. 12‐ Lymphocyte count and comparison of results in treatment and control groups. Timepoint: On days 1, 5 and 14 of the start of treatment. Method of measurement: Blood biochemical test. 13‐ Length of respiratory symptoms and comparison of results between treatment and controlgroups. Timepoint: On days 1, 5 and 14 of the start of treatment. Method of measurement: Check spirometric test information. 2‐ Organ failure and comparison of these results in the two groups of treatment and control. Timepoint: On days 1, 5 and 14 of the start of treatment. Method of measurement: Examination and registration of clinical signs. 3‐ Mortality and comparison of these results in the two groups of treatment and control. Timepoint: On days 1, 5 and 14 of the start of treatment. Method of measurement: Record vital signs. 4‐ The length of hospital stay and comparison of these results in the treatment and controlgroups. Timepoint: On days 1, 5 and 14 of the start of treatment. Method of measurement: Evaluation of the length of hospital stay. 5‐ Length of ICU hospitalization and comparison of these results in the treatment and controlgroups. Timepoint: On days 1 and 5 of the start of treatment. Method of measurement: Check the period of hospitalization in the ICU. 6‐ Receiving oxygen and comparing these results in the treatment and control groups. Timepoint: On days 1, 5 and 14 of the start of treatment. Method of measurement: Nursing information on the use of oxygen capsules. 7‐ The length of the negative period of PCR test and comparison of these results in thetreatment and control groups. Timepoint: On days 1 and 14 of the start of treatment. Method of measurement: Polymerase Chain Reaction. 8‐ Comparison of interleukin‐6 levels in the treatment and control groups. Timepoint: On days 1 and 14 of the start of treatment. Method of measurement: Polymerase Chain Reaction. 9‐ Comparison of patients' ferritin levels in treatment and control groups. Timepoint: On days 1, 5 and 14 of the start of treatment. Method of measurement: Blood biochemical test.
Epistemonikos ID: 266286026b9e32878e3f33f7bacf7bb76b539eca
First added on: Aug 31, 2020