Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Test Group: Integrated biofeedback based yoga program
Covid 19 patients take part in a 2 week Integrated biofeedback based yoga program following admission to a tertiary Covid 19 screen
Sponsors
Central Council for Research in Yoga and Naturopathy Ministry of AYUSH
Eligibility
Inclusion criteria
Inclusion criteria: 1.Covid 19 positive case diagnosed using RT PCR in authorized Covid19 testing facility 2.Mild clinical presentation (identified at the time of admission to ward by National Early Warning Score NEWS-2; mild 0-4; severe 5-6) 3.Presenting with or without flu symptoms 4.Aged 18-60 years 5.High school education 6.Written consent to participate in any arm of the study 7.Those having a smart phone mobile device with android or IOS operating system.
Exclusion criteria
Exclusion criteria: 1.Severe infection News-3-4 requiring admission to ICU. 2.Unable to take oral medication, 3.Immunocompromised, 4.Creatinine clearance (CCL) 5.Aspartate transaminase (AST) or alanine transaminase (ALT) > 5 times Upper limit of normal (ULN), 6.d-dimer > 2microgram per liter, or 7.Uncontrolled diabetes, Hypertension, Existing Heart disease and heart failure, any cancer, autoimmune disease, stroke, neurodegenerative diseases etc.. 8.Clinical condition that reduces survival to less than six months. 9.Pregnancy and lactating mothers 10.Clinical signs suggestive of septicemia and multi organ dysfunction. 11. Score of less than 24 points on the Folstein Mini-Mental State Examination(43). 12.Score of more than 14 points on the 9-item Patient Health Questionnaire (PHQ-9) depression screen (44). 13.BMI less than 18
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be defined as area-under-the curve global severity for all ARI illness days throughout observation, from consent to study exitTimepoint: Day 0 to study exit | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to discharge/recovery: Discharge/recovery, ICU admissions and Death will be considered events. Time to event analysis will be carried out as one of the outcomes. Will be a study endpoint. 2. Biomarkers: With each ARI illness episode, a nasal wash /throat swab will be collected in VTB medium within 3 days of symptom onset and analyzed for covid 19 using Multiplex polymerase chain reaction (PCR) This test will be done at baseline and 14 days. Timepoint: Day 0 and Day 14 | — |
Countries
India
Contacts
Public ContactDr Raghavendra Rao M
Central Council for Research in Yoga & Naturopathy (CCRYN)
Outcome results
None listed