CTRI/2022/04/041704
Recruiting
Phase 3
Randomized Controlled Trial of the Efficacy of ProGenX in the Resolution of Post-COVID Fatigue & Immune status
ihar Ranjan Pradhan0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Sponsor
- ihar Ranjan Pradhan
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •Prior known respiratory distress (RR\-30 times/min);
- •Finger oxygen saturation \< 90% in a resting state,
- •Arterial partial pressure of oxygen(pao2\)/concentration of oxygen inhalation (Fio2\) \<300 mmHg;
- •Respiratory failure or on mechanical ventilation,
- •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
Outcomes
Primary Outcomes
Not specified
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