Open Label Study to Evaluate the Safety and Efficacy of SwasVimochan, SwasanRakshak, Swasamrit, Immune Energy Tablets with Mild to Moderate COVID-19 Patients

Not Applicable

Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Registration Number: CTRI/2021/03/031664

Lead Sponsor: Someshwar Cosmic Energy Research Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Subject 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.

4. Finger Oxygen saturation 88 to 92% in rest state.

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

Patient with severe to critical type of health condition as stratified below:

Clinical stratification:

Severe type : meeting any of the following criteria:

Respiratory distress, RR >30 times/min;

Critical type:meeting any of the following criteria:

a) Respiratory failure occurs and mechanical ventilator is required.

b) Patients go into shock.

c) ICU is needed for other organ failure.

Other viral pneumonia.

1.Patients on anticoagulant (such as aspirin, Wasfarin , heparine etc.) ( Note : patient who need anticoagulant added to their SOC regimen as per the discreation of the treating physician will be withdrawn from the study)

2.Patient who have recived tumor immunotherapy ( such as PD-1/L1,CTLA4, etc.) in the past 1 month, and inflammation factor modulator such as Ulinastatin.

3.patient who have received organ transplantation or surgery planning in the past 6 month.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Proportion of patients showing clinical improvement. <br/ ><br>2)Improvement in Weakness. <br/ ><br>3)Improvement in SpO2 Levels. <br/ ><br>4)Time to first negative SARS-CoV-2 RT-PCR. <br/ ><br>5)Duration of hospitalization. <br/ ><br>6) Duration of supplemental oxygen therapy. <br/ ><br>7) Time to Normalization of Symptoms.Timepoint: 1) Proportion of patients showing clinical improvement Clinical improvement.Day 5, 9 and Upto Day 21. <br/ ><br>2)Improvement in Weakness.Up to 3 Weeks (21 Days). <br/ ><br>3)Improvement in SpO2 Levels. Up to 3 Weeks (21 Days). <br/ ><br>4)Time to first negative SARS-CoV-2 RT-PCR.Day 5, 9 and Upto 21 Days. <br/ ><br>5)Duration of hospitalization. Upto 3 Weeks. <br/ ><br>6) Duration of supplemental oxygen therapy, Upto 3 Weeks. <br/ ><br>7) Time to Normalization of Symptoms, Upto 3 Weeks.

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety of SwasVimotion,SwasRaksha,Swasamrit,ImmuneEnergy tablet in comparison to the standard of care for the treatment of mild to mild to moderate COVID-19 disease.Timepoint: 1.Time(Days) to clinical improvement {Time Frame:upto 21 days}. <br/ ><br>2. Clinical improvement defined as patient meeting discharge criteria OR a 2 point improvement (from time of enrolment in disease severity rating on the 7-point ordinal scale. The ordinal scale. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day