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A clinical study on Ayurveda intervention along with Standard Care Treatment in mild to moderate patients of COVID-19

Not Applicable
Conditions
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Registration Number
CTRI/2021/05/033651
Lead Sponsor
Dr SR Rajasthan Ayurved University Jodhpur
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.All hospitalized cases 18-60 years of age, clinically diagnosed with corona virus disease 2019 (Covid19) and who are symptomatic and having Mild to moderate symptoms.

2.Participants who can take medicines orally.

3.Patients taking standard care treatment

4.Patients willing to provide signed informed consent.

Exclusion Criteria

1.Cases of severe vomiting which would affect oral administration of medicine difficult.

2.Cases of respiratory failure and requiring mechanical ventilation.

3.Patients having Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 5 times the upper range of normal limits.

4.Patients with COVID-19 in critical condition or ARDS or NIAD 8 â??point ordinal score-2 (Hospitalized, on invasive mechanical Ventilation or extra corporeal membrane oxygenation

5.Combined organ failure requiring ICU monitoring.

6.Patients with uncontrolled Diabetes Mellitus, (HbA1c more than 8.0), Malignant Hypertension (systolic BP more than 180 and diastolic 110), Chronic Renal Failure and those on immunosuppressive medication.

7.Patients with history of malignancy, IHD, CAD, triple vessel disease, history of CABG, Stroke, etc.

8.Any other condition, which as per the investigator would jeopardize the outcome of the trial.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1.Clinical cure rate: Time to get a negative status of Covid-19. (defined as viral load of respiratory specimen negative for two consecutive times when tested in an interval of two days) [Time frame 1 month] <br/ ><br>2.Duration of fever and each of the respiratory symptoms [Time frame 1 month]. <br/ ><br>Timepoint: 4weeks <br/ ><br>
Secondary Outcome Measures
NameTimeMethod
1.No of cases Reporting any ADR/AE <br/ ><br>2.Number of patients referred. <br/ ><br>3. Number of cases that required invasive or non-invasive oxygen therapy during the intervention. <br/ ><br>4.Number of cases that progressed to multi- organ failure while under clinical trial. <br/ ><br>Timepoint: 1 month <br/ ><br>
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