Clinical trial of Madhav Rasayan in subjects of COVID 19.
Phase 2
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/04/032541
- Lead Sponsor
- Shree Vishwavati Ayurvedic Chikitsalaya and Research Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 <br/ ><br>Reduction in elevated levels of inflammatory markers such as CRP, LDH and Ferritin <br/ ><br>Subject population with negative RT-PCR for Covid 19Timepoint: From baseline, day 5 and day 10 ie end of study
- Secondary Outcome Measures
Name Time Method Requirements of supplemental oxygen <br/ ><br>Improvement in SpO2 levels <br/ ><br>Requirement of admission to intensive care unit <br/ ><br>Duration of hospitalization <br/ ><br>Changes in Sino-nasal Complaints evaluated by modified SNOT questionnaire <br/ ><br>Improvement in sleep by disturbed sleep questionnaire score <br/ ><br>Assessment of cognition through questionnaire <br/ ><br>Assessment of fatigue by modified fatigue severity scale <br/ ><br>Improvement in QoL by 5 ED questionnaireTimepoint: From baseline, day 5 and day 10 ie end of study