CTRI/2020/05/025320RecruitingPhase 3 4
NATUROPATHY AND YOGA IN THE MANAGEMENT OF COVID19A Multi-center controlled clinical trial
Government Yoga And Naturopathy Medical College Chennai4 sites in 1 country658 target enrollmentStarted: May 22, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 658
- Locations
- 4
- Primary Endpoint
- Time to progress to next stage of severity i.e., from asymptomatic/uncomplicated/mild pneumonia to moderate/severe stages
Study Overview
Brief Summary
YONAC trial is a multi-centre controlled trial aimed at improving outcomes in patients diagnosed with COVDI19 with Yoga & Naturopathy treatment modalities which includes a natural immune boosting fresh juice (, natural immune boosting hot drink and Yoga. In addition, based on the need, hot water gargling, steam inhalation, essential oil (eucalyptus/peppermint/thyme/lavendar/basil), self acupressure will be provided to the patients.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •a)Written informed consent prior to performing study procedures.
- •Witnessed oral consent will be accepted in order to avoid paper handling.
- •Written consent by patient or their family members will be obtained wherever applicable.
- •b)Male or Female adult patient ≥18 years and ≤75 years of age at the time of recruitment c)Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR in naso/oropharyngeal swabs or any other relevant specimen d)Asymptomatic / uncomplicated illness / mild pneumonia COVID-19 as defined by ICMR.
Exclusion Criteria
- •a)Explicit non-willingness to be a part of the research study b)Patients with moderate/severe stages of COVID19 c)Participation in any other clinical trials.
Outcomes
Primary Outcomes
Time to progress to next stage of severity i.e., from asymptomatic/uncomplicated/mild pneumonia to moderate/severe stages
Time Frame: At 15 days
Secondary Outcomes
- Clinical endpoints(1. Time to All-cause mortality at discharge)
Investigators
Study Sites (4)
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