Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: ImmunoSEB ProbioSEB CSC3: ImmunoSEB + ProbioSEB CSC3: 2 capsules ImmunoSEB bid (500 mgs) + 2 capsules ProbioSEB CSC3 (5 billion CFUs) od for 14 days
Control Intervention1: Placebo: Malt
Sponsors
Advanced Enzyme Technologies Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Subjects will be included in the study if they meet all of the following criteria: 1.Provides written informed consent 2.Male or non-pregnant, non-lactating female aged � 18 and � 75 years (both inclusive) 3.RT-PCR confirmed diagnosis of Covid-19 at any time followed by an RT-PCR negative test 4.Patients who are experiencing fatigue and muscle weakness 5.Able to take the drug orally and comply with study procedures 6.Women of childbearing potential must have a negative urine pregnancy test prior to study entry
Exclusion criteria
Exclusion criteria: EXCLUSION CRITERIA Patient will be deemed ineligible to participate in the study if he/she fulfils any of the following criteria: 1.Patients with severe to critical type of health condition as stratified below: 2.Clinical stratification: 3.Severe type: meeting any of the following criteria: (a)Respiratory distress, RR�30 times/min (b)Finger oxygen saturation �90% in resting state (c)Arterial partial pressure of oxygen (PaO2)/concentration of oxygen inhalation (FiO2)�300mmHg. 4.Critical type: meeting any of the following criteria: (a)Respiratory failure occurs and mechanical ventilation is required; (b)Patients go into shock; (c) ICU is needed for other organ failure. 5.Other viral pneumonia Patients who can not take food or drugs due to coma or intestinal obstruction 6.Consumption of other oral probiotic supplements during the trial 7.Patients who have severe underlying diseases that affects survival, including uncontrolled malignant tumor with multiple metastases that cannot be resected, blood diseases, dyscrasia, active bleeding, severe malnutrition, etc. 8.Women subjects that are pregnant or lactating, or subjects (including male subjects) having a pregnancy plan (including plans for sperm donation or egg donation) during the study period 9.Allergic to systemic enzyme supplements. 10.Imminent death in the opinion of the clinical team 11.Patients with Hb less than 8 mg/dl 13.Patients who have participated in any other clinical study within 2 weeks prior to randomization; 14.The investigator concludes that the patient is not suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Proportion of patients showing improvement on Chalder Fatigue Scale. 2. Proportion of patients showing Improvement in mental Fatigue on CFQ.Timepoint: 1.Proportion of patients showing improvement in physical Fatigue on CFQ [Time Frame: Day 14] 2.Proportion of patients showing Improvement in mental Fatigue on CFQ [Time Frame: Day 14] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Proportion of patients showing improvement in mental fatigue. 2.Proportion of patients showing improvement in physical fatigue. 3.Proportion of patient requiring additional therapy for fatigue. 4.Number of AEs and SAEs. Timepoint: 1.Proportion of patients showing improvement [Time Frame: Day 4] 2.Proportion of patients showing improvement [Time Frame: Day 8] 3.Proportion of patients showing improvement [Time Frame: Day 11] 4.Proportion of patients showing improvement [Time Frame: Day 14] | — |
Countries
India
Contacts
Public ContactMukul Maurya
Chirayu Medical College and Hospital
Outcome results
None listed