Single Center,Study on Evaluation of use of,“AYURCOV†as add on therapy for Treatment of SARS-CoV-2 Infection in COVID-19 Patients,at Tertiary Care Center.
- Conditions
- Coronavirus as the cause of diseases classified elsewhere, (2) ICD-10 Condition: J22||Unspecified acute lower respiratory infection,
- Registration Number
- CTRI/2020/06/026262
- Lead Sponsor
- Bhaktivedanta Hospital and Research Institute
- Brief Summary
Prospective, single center ,open label, randomized controlled , pilot study on evaluation of use of ,“AYURCOV†as an adjuvant for treatmentpurpose in treatment of SARS-CoV-2 infection for covid-19 patients , at tertiary care center.
Study procedures shall be initiated post obtaining written informed consent process, as per local regulatory requirements. Randomization of the groups would be done as per computer generated charts , details of the randomization are as per below mentioned chart. Randomization chart is enclosed along with the protocol for reference .
| | | | |
| --- | --- | --- | --- |
|Study Participants Distribution ( By Randomization technique )
|Group
Group Criteria Definition
Standard of care and Ayurcov
Only Standard of care
|1
COVID -19 Positive patients (Mild and Moderate Cases)
45
45
|2
COVID -19 Positive patients (Severe Cases )
15
15
|
1. Mild to Moderate Covid-19 Patients: Non-pneumonia and mild pneumonia
2. Severe Covid-19 Patients : Dyspnea, respiratory frequency ≥ 30/min, blood oxygen saturation (SpO2) ≤ 93%, PaO2/FiO2 ratio < 300, and/or lung infiltrates > 50% within 24 to 48 hours .
Duration of the study participation is 1 month. As mentioned in the chart above there are four groups in the study . Every group is further divided in 2 subgroups of which one group will get standard of care and Ayurcov and another group will get only standard of care.
Study doctor will participants medical records to study, effect of study drug on participant disease . Study doctor will examine study participants during your hospital stay to observe for any side effects . Study doctor will follow up telephonically 1 week post discharge to enquire study participants about their health status .
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
- 1.COVID -19 Positive patients 2.Agree to consent for the study.
- 3.All Age groups above 18 Years 4.All genders.
- Unable to be followed-up during the trial 2.
- Current or future involvement in the active treatment phase of other interventional research studies (excluding observational/non-interventional studies) .
- Any other clinical reason which may preclude entry in the opinion of the investigator.
- 4, Pregnant Women.
- 5.Patients who are on ventilator support .
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method COVID 19 FREE DISEASE AT TIME OF DISCHARGE
- Secondary Outcome Measures
Name Time Method SEVERITY OF COVID 19 DISEASE DURING HOSPITALIZATION AND AT TIME OF DISCHARGE
Trial Locations
- Locations (1)
Department of Ayurveda ,Bhaktivedanta Hospital and Research Institute
🇮🇳Thane, MAHARASHTRA, India
Department of Ayurveda ,Bhaktivedanta Hospital and Research Institute🇮🇳Thane, MAHARASHTRA, IndiaDr Nanasaheb MemanePrincipal investigator08767271628drmemane@bhaktivedantahospital.com