Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
None listed
Sponsors
Nihar Ranjan Pradhan
Eligibility
Inclusion criteria
Inclusion criteria: Males or non-pregnant, non-lactating females aged - 18 to 75 years (both inclusive); RT-PCR confirmed diagnosis of COVID-19 at any time followed by an RT-PCR negative test; Patients experiencing fatigue and muscle weakness; Able to take the drug orally and comply with study procedures; Women of childbearing potential with a negative urine pregnancy test.
Exclusion criteria
Exclusion criteria: Prior known respiratory distress (RR-30 times/min); Finger oxygen saturation Arterial partial pressure of oxygen(pao2)/concentration of oxygen inhalation (Fio2) Respiratory failure or on mechanical ventilation, In shock; ICU needed for other organ failure; Patients with other viral pneumonia; Patients unable to take food or drugs due to coma or intestinal obstruction; Consumption of other oral probiotic supplements during the trial; Patients with severe underlying diseases that affects survival, including uncontrolled malignant tumor with multiple metastases that cannot be resected; Blood diseases Dyscrasia; Active bleeding Severe malnutrition Women who are pregnant or lactating Subjects (including male subjects) having a pregnancy plan (including plans for sperm donation or egg donation) during the study period; Patients allergic to systemic enzyme supplements; Patients facing imminent death in the opinion of the clinical team; Patients with Hb less than 10 g/dl; Patients who have participated in any other clinical study within 2 weeks prior to randomization
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Change in the following parameters CRP Imunoglobulins ââ?¬â?? IgA, IgM and IgG Antinuclear antibody Total Protein Complete Blood Count with a five-part differential to determine total white cells, total lymphocytes and total eosinophilTimepoint: Day 30 | — |
Primary
| Measure | Time frame |
|---|---|
| proportion of patients showing improvement in physical fatigue on CFQ-11 and the proportion of patients showing improvement in mental fatigue on CFQ-11.Timepoint: Day 30 | — |
Countries
India
Contacts
Public ContactKumar Guru Mishra
AIIMS Bibinagar
Outcome results
None listed