Efficacy of Ayurveda treatment Protocol with Tulsimmune Tablet in Covid 19

Phase 1

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

Registration Number: CTRI/2020/07/026675

Lead Sponsor: Suraj Ayurveda Clinic and Research center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Age Eligible for Study:18 Years to 75, male female

2.Subject must meet the WHO/MOHFW India /ICMR Criteria having symptoms of SARS CoV2 described in WHO Report/groups described by MOHFW India, (Group B,C,D,E mainly)

3.Quarantine/non hospitalized or hospitalized AND Fulfills WHO case definition, including a positive PCR for COVID-19 from any specimen (e.g. respiratory, blood, urine, stool, other bodily fluid) and other analysis.

Exclusion Criteria

1.Active indication and use for one of the investigational products (e.g. HIV positive or active hepatitis B if antiretroviral agents were used )

2.Allergy or other contraindication or one of the investigational products

3.In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.

4.Participant with any immunosuppressive condition or hematological disease

5.Participation in any other A.S.U and H protocol

6.Pregnant woman and lactating mother

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the severity index of symptoms of SARS-CoV 2 patients in public/private hospitals in Maharashtra. <br/ ><br>1.Severity of disease in SARS-CoV-2 assessed by <br/ ><br>No symptoms-1 <br/ ><br>Mild symptoms-fever, dry cough, myalgia, fatigue, anosmia-2 <br/ ><br>Moderate symptoms-mild symptoms plus shortness of breath, dyspnoea-3 <br/ ><br>â?¢Severe symptoms-respiratory insufficiency that requires Oxygen support and mechanical ventilation-4 <br/ ><br>2. Duration of symptoms in Patients of SARS-CoV-2 measured in days <br/ ><br>Timepoint: Day 0, day 14

Secondary Outcome Measures

Name	Time	Method
Change in clinical severity if any of SARS-CoV-2 patients among hospitals in Maharashtra measured with whatever possible Investigations done in hospital on admission like CBC/CRP/LFT/RFT/CPK-total/APTT/PT-INR/D-DIMER/LDH/Sr. Ferritin/Sr. Troponin-I/HbA1c/Viral markers IL-6/IgM(optional) pulmonary imaging like Chest X-ray etc, ECG and in due course of hospitalizationTimepoint: Change in Lab testing Pulmonary Imaging etc if any Day 0 day 14