Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Madhav Rasayan Tablets: Madhav rasayan tablets would be administered in 250 mg twice a day dosage for 10 days
Control Intervention1: Standard of care: Standard of care as per ICMR
proto
Sponsors
Shree Vishwavati Ayurvedic Chikitsalaya and Research Centre
Eligibility
Inclusion criteria
Inclusion criteria: Confirmed COVID 19 patient with positive RT-PCR Moderate to severe symptomatic patients having no signs of ARDS (NEWS score less than or equal to 8) Subject willing to provide consent and follow up for study duration
Exclusion criteria
Exclusion criteria: Patients with autoimmune disease or self-reports HIV or syphilis infection Proves to be unfit for the study as per the investigatorâ??s discretion Pregnant or lactating women Requiring ICU admission and mechanical ventilation at the screening Subjects with signs of ARDS Any other comorbidity which is the critical stage at screening which in investigator discretion finds subject not suitable for the trial participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of clinical symptoms including cough, breathlessness, gastric disturbance, anosmia, fatigue and myalgia on 10 point VAS scale 0- no symptom and 10-severe symptom Reduction in elevated levels of inflammatory markers such as CRP, LDH and Ferritin Subject population with negative RT-PCR for Covid 19Timepoint: From baseline, day 5 and day 10 ie end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Requirements of supplemental oxygen Improvement in SpO2 levels Requirement of admission to intensive care unit Duration of hospitalization Changes in Sino-nasal Complaints evaluated by modified SNOT questionnaire Improvement in sleep by disturbed sleep questionnaire score Assessment of cognition through questionnaire Assessment of fatigue by modified fatigue severity scale Improvement in QoL by 5 ED questionnaireTimepoint: From baseline, day 5 and day 10 ie end of study | — |
Countries
India
Contacts
Public ContactDr Tushar Saundankar
Shree Vishwavati Ayurvedic Chikitsalay and Research Centre
Outcome results
None listed