Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Homoeopathic medicines: Routinely used homoeopathic medicines for various kinds of flu will be repurposed for COVID 19 treatment. Dose: Orally, 3 times a day, or more frequently, depend
Dispensing form: 4-5 pills at a time, or 1-2 drops in 1 tbsp. of drinking water. Duration: 28 days, or discharge from hospital, whichever is earlier
Control Intervention1: Standard of care: Routinely
Sponsors
Central Council for Research in Homoeopathy
Eligibility
Inclusion criteria
Inclusion criteria: •Age > 18 years •All sexes •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 13 June 2020 . o Moderate: Pneumonia with presence of clinical features of dyspnea and or hypoxia, fever, cough, including SpO2 o Severe: ï?§ Adolescent or adult with clinical signs of Pneumonia plus one of the following; respiratory rate >30 breaths/min, severe respiratory distress, SpO2 ï?§ Acute Respiratory Distress Syndrome Onset: ï?§ New or worsening respiratory symptoms within one week of known clinical insult. ï?§ Chest imaging (Chest X ray and portable bed side lung ultrasound): bilateral opacities, not fully explained by effusions, lobar or lung collapse, or nodules. Origin of Pulmonary infiltrates: respiratory failure not fully explained by cardiac failure or fluid overload. Need objective assessment (e.g. echocardiography) to exclude hydrostatic cause of infiltrates/ oedema if no risk factor present. ï?§ Oxygenation impairment in adults: • Mild ARDS: 200 mmHg =5 cm H2O) • Moderate ARDS: 100 mmHg =5 cm H2O) • Laboratory confirmed SARS CoV-2 infection within last 10 days or SARS • CoV-2 test result pending with a high clinical suspicion as defined by: o Cough of o Bilateral pulmonary infiltrates on chest X Ray / CT scan or new hypoxaemia defined as SpO2 o No alternative explanation for respiratory symptoms • Scheduled for admission or enrolled within 48h of hospital admission
Exclusion criteria
Exclusion criteria: •Pregnant and lactating women, infants and neonates •Not willing to give consent for adjuvant treatment •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. •Symptoms of acute respiratory tract infection for > 10d before randomisation •Death within 24 Hrs. of admission
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare duration required in being free from oxygen support device (breathing independently in room air) 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: Daily assessment for need of Oxygen requirement and how much quantity. | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢Change in Scores of COVID Ordinal Clinical Outcomes Scale at D2, D7, D14, D28, in comparison to the control group.Timepoint: â?¢Change in Scores of COVID Ordinal Clinical Outcomes Scale at D2, D7, D14, D28, in comparison to the control group.;Changes in standard of care assessment parameters for clinical improvement, primarily oxygen on room air in moderate cases, and improvement in D-Dimer, IL6 and S. Ferritin in severe cases.Timepoint: Time taken for clinical improvement, primarily oxygen on room air in moderate cases, and improvement in D-Dimer, IL6 and S. Ferritin in severe cases.;Duration required for change in RTPCR status from positive to negative.Timepoint: Every 5 days | — |
Countries
India
Contacts
Public ContactDr Naval Kumar Verma
Central Council for Research in Homoeopathy (CCRH)
Outcome results
None listed