Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Meditation (Mindful Happiness): Arm A subjects will be advocated to perform meditation (Mindful Happiness) as an adjunct therapy along with standard of care
Control Intervention1: Stand
Sponsors
Sonalika Social development Society
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male female subjects of age group between 18 â?? 60 years 2. Subjects who are COVID-19 confirmed cases, with mild severity presenting with signs and symptoms qualifying for low clinical risk (NEWS scoring 0-4) 3. Subjects with SARS-CoV-2 RT-PCR confirmed COVID-19 positive with 72 hours from symptom onset or patient within 48 hours after laboratory diagnosis (SARS-CoV-2 RT-PCR) 4. Subjects who are literate in English 5. Female of childbearing potential willing to follow reliable and strict contraceptive measures 6. Subjects judged to be reliable for compliance for performing meditation and capable of recording the effects of the meditation and motivated in receiving benefits from the meditation and compliance to quarantine procedure (as per prevailing guidelines) 7. Willingness to provide written inform consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Confirmed COVID-19 positive cases with NEWS scoring system >= 5 2. Individual with acute respiratory distress presenting with RR >24/minute, SaO2/SPO2 3. Those who are regular practitioners of pranayama or meditation, defined as practicing any method of pranayama or meditation or both for at least 50 % of days in the last 1-month period 4. Pregnant and breast-feeding females 5. Recent history of significant lung disease like Asthma or Chronic Obstructive Lung Disease (COPD). 6. Those who have pre-existing severe mental illnesses such as Bipolar disorder or schizophrenia 7. Severe sleep problems defined as less than 3 hours of sleep every day for the preceding 7 days 8. Suffering from Immunocompromising conditions or taking any immunosuppressing therapy 9. Subjects suffering from severe and uncontrolled metabolic, endocrinal, cardiac/ renal/liver disease. 10. The subject who are unable or unwilling to comply fully with the study protocol. 11. Physician makes a decision that trial involvement is not in patientâ??s best interest, or any condition that does not allow the protocol to be followed safely.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Time to Clinical Recovery (duration): 4 weeks 2) Change in PSS scale from baseline between 2 arms 3) Changes in Serum Cortisol Levels from baseline 4) Changes in WHO 5 QOL scale from baseline between 2 arms Timepoint: 1) Time to Clinical Recovery (duration): 4 weeks 2) Change in PSS and Changes in WHO 5 QOL scale from baseline between 2 arms will be evaluated on day 1, day of discharge, day 7 from date of discharge, day 14 from date of discharge. 3) Change in serum cortisol levels from baseline will be evaluated on day 1, date of discharge and 14 days after date of discharge | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)No. & Percentage of subjects converting into severe cases. 2) Hospital length of stay (from the time of onset of symptoms) 3) Proportion of clinical failure -ICU admission, mechanical ventilation, or death 4) Incidence of any opportunistic infection 5) Change in Cytokine levels as an index of inflammationTimepoint: All outcomes will be evaluated throughout the study, except change in cytokine levels will be evaluated on Baseline / Day 1 Visit and Visit 4 / 14 days from the date of discharge ±3 day (EOS) | — |
Countries
India
Contacts
Public ContactMeena Dalal
Wow Power Yoga
Outcome results
None listed