Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Madhav Rasayan Plus: Madhav Rasayan Plus capsule 250 mg BD orally along with standard of care for 15 days
Control Intervention1: Standard of care: Standard of care as per ICMR protocol
Sponsors
Shree Vishwavati Ayurvedic Chikitsalaya and Research Centre
Eligibility
Inclusion criteria
Inclusion criteria: Age -18- 60 years (Both sex) Confirmed COVID 19 patient with positive RT-PCR Moderate to severe symptomatic patients having no signs of ARDS (NEWS score 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 at screening Any other comorbidity which is 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 Reduction in levels of tissue level markers like Creatinine Phosphokinase and NT-Pro BNPTimepoint: Baseline to end of study ie 15 days | — |
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 questionnaire Safety of the intervention Assessment of mental wellness questionnaireTimepoint: Baseline to end of study ie 15 days | — |
Countries
India
Contacts
Public ContactDr Tushar Saundalgikar
Shree Vishwavati Ayurvedic Chikitsalay and Research Centre
Outcome results
None listed