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