A clinical trial to evaluate the medicinal efficacy and safety of Ayurvedic kit in COVID-19 positive Patients.

Phase 2

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

Recruitment & Eligibility

Inclusion Criteria

1.Patients willing to give written informed consent

2.Patients of either sex aged between 18 and 60 years.

3.Patients diagnosed with COVID-19 positive (confirmed by RT-PCR)

Mild symptomatic patients (Patients with uncomplicated upper respiratory tract infection) such as:

SpO2: >=94% in room air

RR: <= 24/m

No evidence of hypoxemia or breathlessness

Exclusion Criteria

1.Patients who is not willing to give consent for the study.

2.Patients who has uncontrolled comorbidities like Diabetes, Hypertension and heart diseases.

3.Patients with pre-existing respiratory conditions, renal and liver diseases.

4.Immunocompromised individuals/those on immunosuppressants.

5.Female patients who are pregnant/ lactating or considering pregnancy.

6.Psychiatric or emotional disturbance in patients which would limit ability of the patients to comply.

Primary Outcome Measures

Name	Time	Method
1.Number of patients achieving Virological cure <br/ ><br>2.Time to achieve Virological cure <br/ ><br>Virological cure is defined as RT-PCR turning negativeTimepoint: Day 1 baseline assessment Day 3 Telephonic follow-up will be done for improvement in symptoms and Side-effects Day 7 Telephonic assessment with RT-PCR will be done <br/ ><br>Day 10 Telephonic assessment with Total count and differential count of WBCs, D-dimer, CRP, Derived Neutrophil to Lymphocyte Ratio: d-NLR will be done

Secondary Outcome Measures

Name	Time	Method
1 Number of patients achieving Clinical cure <br/ ><br>2 Time to achieve Clinical cure <br/ ><br>3 Improvement in WBC count, D-dimer, CRP, d-NLR from admission to day 10. <br/ ><br>4 Number and severity of adverse events <br/ ><br>Clinical cure is defined as- one or more of the following: <br/ ><br>-Continuous decrease in temperature/attaining normal temperature (normal temperature rate axillary 97.8 degree F) <br/ ><br>-Respiratory rate 20/min <br/ ><br>-Oxygen saturation 98 % without oxygen supplementation <br/ ><br>-No coughTimepoint: Day 1-Baseline assessment <br/ ><br>Day 3-Telephonic follow-up will be done for improvement in symptoms and Side-effects <br/ ><br>Day 7-Telephonic assessment and RT-PCR will be done <br/ ><br>Day 10-Telephonic assessment with Total count and differential count of WBCs, D-dimer, CRP, Derived Neutrophil to Lymphocyte Ratio (d-NLR) will be done