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

Completed

Conditions: Coronavirus as the cause of diseases classified elsewhere. Ayurveda Condition: COVID-19,

Registration Number: CTRI/2021/03/031664

Lead Sponsor: Someshwar Cosmic Energy Research Center

Brief Summary: The outbreak of coronavirus disease 2019 (COVID-19), caused by SARS-CoV-2 in December 2019 has raised global health concerns. Coronaviruses (CoVs) are enveloped RNA Viruses related to the family Coronaviridae, the order Nirdovales, that infect humans and other mammals. The disease is characterized by fever, cough, headache and other constitutional symptoms. There has been morbidity and mortality with COVID-19.

A Proof of Concept study using SwasVimochan + SwasanRakshak + Swasamrit + Immune Energy Tablets as therapy in confirmed mild to moderate COVID-19 patients.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

Subject will be included in the study if they meet all of the following criteria: 1.
Provides written informed consent.
Male or non-pregnant, non-lactating female aged > 18 and < 75 years (both inclusive) 3.
RT-PCR confirmed diagnosis of COVID-19.
Finger Oxygen saturation 88 to 92% in rest state.
5.Able to take the drug orally and comply with study procedures.
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: patient who need anticoagulant added to their SOC regimen as per the discreation of the treating physician will be withdrawn from the study) 2.Patient who have recived tumor immunotherapy ( such as PD-1/L1,CTLA4, etc.)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
2)Improvement in Weakness.	1) Proportion of patients showing clinical improvement Clinical improvement.Day 5, 9 and Upto Day 21. \| 2)Improvement in Weakness.Up to 3 Weeks (21 Days). \| 3)Improvement in SpO2 Levels. Up to 3 Weeks (21 Days). \| 4)Time to first negative SARS-CoV-2 RT-PCR.Day 5, 9 and Upto 21 Days. \| 5)Duration of hospitalization. Upto 3 Weeks. \| 6) Duration of supplemental oxygen therapy, Upto 3 Weeks. \| 7) Time to Normalization of Symptoms, Upto 3 Weeks.
6) Duration of supplemental oxygen therapy.	1) Proportion of patients showing clinical improvement Clinical improvement.Day 5, 9 and Upto Day 21. \| 2)Improvement in Weakness.Up to 3 Weeks (21 Days). \| 3)Improvement in SpO2 Levels. Up to 3 Weeks (21 Days). \| 4)Time to first negative SARS-CoV-2 RT-PCR.Day 5, 9 and Upto 21 Days. \| 5)Duration of hospitalization. Upto 3 Weeks. \| 6) Duration of supplemental oxygen therapy, Upto 3 Weeks. \| 7) Time to Normalization of Symptoms, Upto 3 Weeks.
4)Time to first negative SARS-CoV-2 RT-PCR.	1) Proportion of patients showing clinical improvement Clinical improvement.Day 5, 9 and Upto Day 21. \| 2)Improvement in Weakness.Up to 3 Weeks (21 Days). \| 3)Improvement in SpO2 Levels. Up to 3 Weeks (21 Days). \| 4)Time to first negative SARS-CoV-2 RT-PCR.Day 5, 9 and Upto 21 Days. \| 5)Duration of hospitalization. Upto 3 Weeks. \| 6) Duration of supplemental oxygen therapy, Upto 3 Weeks. \| 7) Time to Normalization of Symptoms, Upto 3 Weeks.
1) Proportion of patients showing clinical improvement.	1) Proportion of patients showing clinical improvement Clinical improvement.Day 5, 9 and Upto Day 21. \| 2)Improvement in Weakness.Up to 3 Weeks (21 Days). \| 3)Improvement in SpO2 Levels. Up to 3 Weeks (21 Days). \| 4)Time to first negative SARS-CoV-2 RT-PCR.Day 5, 9 and Upto 21 Days. \| 5)Duration of hospitalization. Upto 3 Weeks. \| 6) Duration of supplemental oxygen therapy, Upto 3 Weeks. \| 7) Time to Normalization of Symptoms, Upto 3 Weeks.
3)Improvement in SpO2 Levels.	1) Proportion of patients showing clinical improvement Clinical improvement.Day 5, 9 and Upto Day 21. \| 2)Improvement in Weakness.Up to 3 Weeks (21 Days). \| 3)Improvement in SpO2 Levels. Up to 3 Weeks (21 Days). \| 4)Time to first negative SARS-CoV-2 RT-PCR.Day 5, 9 and Upto 21 Days. \| 5)Duration of hospitalization. Upto 3 Weeks. \| 6) Duration of supplemental oxygen therapy, Upto 3 Weeks. \| 7) Time to Normalization of Symptoms, Upto 3 Weeks.
5)Duration of hospitalization.	1) Proportion of patients showing clinical improvement Clinical improvement.Day 5, 9 and Upto Day 21. \| 2)Improvement in Weakness.Up to 3 Weeks (21 Days). \| 3)Improvement in SpO2 Levels. Up to 3 Weeks (21 Days). \| 4)Time to first negative SARS-CoV-2 RT-PCR.Day 5, 9 and Upto 21 Days. \| 5)Duration of hospitalization. Upto 3 Weeks. \| 6) Duration of supplemental oxygen therapy, Upto 3 Weeks. \| 7) Time to Normalization of Symptoms, Upto 3 Weeks.
7) Time to Normalization of Symptoms.	1) Proportion of patients showing clinical improvement Clinical improvement.Day 5, 9 and Upto Day 21. \| 2)Improvement in Weakness.Up to 3 Weeks (21 Days). \| 3)Improvement in SpO2 Levels. Up to 3 Weeks (21 Days). \| 4)Time to first negative SARS-CoV-2 RT-PCR.Day 5, 9 and Upto 21 Days. \| 5)Duration of hospitalization. Upto 3 Weeks. \| 6) Duration of supplemental oxygen therapy, Upto 3 Weeks. \| 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.	1.Time(Days) to clinical improvement {Time Frame:upto 21 days}.

Trial Locations

Locations (3): Chirayu Medical College & Hospital
🇮🇳
Bhopal, MADHYA PRADESH, India
Lotus Multispeciality Hospital
🇮🇳
Ahmadabad, GUJARAT, India
Rajiv Gandhi Medical College & CSMH
🇮🇳
Thane, MAHARASHTRA, India
Chirayu Medical College & Hospital
🇮🇳Bhopal, MADHYA PRADESH, India
Dr Rohit Parate
Principal investigator
9630033342
rohitparate963@gmail.com