Standard of care with homoeopathy as adjuvant in COVID19
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/10/028279
- Lead Sponsor
- Central Council for Research in Homeopathy Ministry Ministry of Ayush
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Age > 18 years
2. All sexes
3. Case definitions for inclusion in the study will include moderate and severe cases as defined in the Guidance on appropriate treatment of suspect/confirmed case of COVID19 issued by Ministry of Health and Family Welfare, Govt of India on 07 Apr 2020.
a. Moderate: Pneumonia with no signs of severe disease (Respiratory Rate 15 to 30/minute, SpO2 90%-94%).
b. Severe: Severe Pneumonia (with respiratory rate < 30/minute and/or SpO2 and requiring non-invasive ventilatory support
4. Laboratory confirmed SARS CoV-2 infection within last 10 days or SARS
5. CoV-2 test result pending with a high clinical suspicion as defined by:
a. Cough of <10d duration
b. Bilateral pulmonary infiltrates on chest X Ray / CT scan or new hypoxaemia defined as SpO2 <94% on room air
c. No alternative explanation for respiratory symptoms
d. Scheduled for admission or enrolled within 48h of hospital admission
1. Children < 18 years
2. Covid Positive patients with severe co-morbidities
3. Pregnant and lactating women, infants and neonates
4. Not willing to give consent for adjuvant treatment
5. Inability to be contacted on D14 for clinical outcome assessment (unless died in hospital)
6. In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
7. Symptoms of acute respiratory tract infection for > 10d before randomisation, and covid status unknown
8. Death within 24 Hrs. of admission
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare duration required for change in disease status (from COVID positive to negative) in patients receiving adjuvant homoeopathic intervention with those receiving conventional treatment as institutional management protocol (IMP) in COVID-19 patients, categorized into moderate to severe stage of the diseaseTimepoint: To compare duration required for change in disease status (from COVID positive to negative) in patients receiving adjuvant homoeopathic intervention with those receiving conventional treatment as institutional management protocol (IMP) in COVID-19 patients, categorized into moderate to severe stage of the disease
- Secondary Outcome Measures
Name Time Method To assess overall symptomatic relief to patients through MYMOP2 scaleTimepoint: 3 Months