Clinical trial of Ayurvedic Medicines in Patients with Asymptomatic and/or Mild Symptoms of COVID-19
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/10/028537
- Lead Sponsor
- Shree Baidyanath Ayurved Bhawan Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 92
Age more than 18 or less than 75 years at time of signing Informed Consent Form.
COVID positive by RTPCR
Cases that have been assigned as mild or very mild or asymptomatic cases of COVID.
Cases presenting with fever and/or upper respiratory tract illness (Influenza like illness, ILI).
No difficulty in swallowing oral medications.
Must agree not to enroll in another study of an investigational agent prior to completion of study.
Allergies, known to be allergic to research drugs or drug excipients;
Subject weight is less than 40 kg
Pneumonia with/without signs of severe disease.
COVID Cases with ARDS or Septic shock.
Patients who have participated in other clinical trials within 1 month.
Known patients with impaired renal function (estimated creatinine clearance <60 mL / min
During the screening or within 24 hours before screening, patients were found to have any of the following laboratory parameter abnormalities (based on local laboratory reference range):-ALT or AST level 5 times the upper limit of normal range (ULN) or-ALT or AST more than 3 times ULN and total bilirubin levels more than 2 times ULN.
Being pregnant or breastfeeding, or having a positive pregnancy test at the time of pre-dose inspection, or planning to become pregnant within 3 months of study treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum levels of Immunological panel CD4, CD8, NK cell panel CD16/CD56 <br/ ><br>Serum CRP levels <br/ ><br>Inflammatory mediators like IL-6 and TNF alpha <br/ ><br>Change in clinical symptom presentation in Fever, Cough, breathlessness, fatigue and myalgia, loss of taste and smell on 5 point ordinal <br/ ><br>Timepoint: From Baseline to End of the Study <br/ ><br>
- Secondary Outcome Measures
Name Time Method Changes in random blood sugar <br/ ><br>Hematological parameters like WBS, RBC and platelet count etc. <br/ ><br>Requirement of admission to Dedicated COVID Hospital <br/ ><br>Duration of hospital admission <br/ ><br>Requirement of ICU admission <br/ ><br>Timepoint: from Baseline to End of the Study