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Clinical Trials/CTRI/2020/06/025800
CTRI/2020/06/025800CompletedPhase 2

A comparative clinical study to involving Ayurvedic drug intervention in the management of COVID 19 patients.

National Health Mission Uttar Pradesh2 sites in 1 country120 target enrollmentStarted: June 22, 2020Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
120
Locations
2
Primary Endpoint
To reduce Virus Clearance Time.

Study Overview

Brief Summary

This was a randomized Clinical comparative study to be conducted at Lokbandhu Rajanarayan Combined Hospital, a COVID 19  level 2 Hospital in Lucknow, Uttar Pradesh. The prime objective was to ascertain the role of Ayurvedic medicine in the Management of COVID 19 Pandemic in India.

Theobservations were noticed and results were analyzed statistically. Improvementin symptoms, enhancement in Agni and recovery from COVID-19 infection was observed. The results obtained were encouraging and showed betterviral clearance and control of symptom progression in the patients placed onAyurvedic medications. 

The most significant findingin this study was that a restrain was observed in the disease progression torigorous stages and evasion of population spread due to faster viral clearancein the management of COVID-19 cases with Ayurveda drugs in both groups A and B than the control group.

This paves the way toa more integrated approach towards this pandemic wherein community spread andprogression to severe stages is the key for its restraint. From here a moreholistic and progressively planned study may be considered involving largersample base for the management of the more severe form of the morbidity whichis the current need of the hour to minimize the mortalities worldwide.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Not Applicable

Eligibility Criteria

Ages
25.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Patients tested Positive for COVID
  • •Asymptomatic Patients or with Mild Symptoms.
  • •Those willing to give informed Consent.

Exclusion Criteria

  • •Patients below 25 years and above 60 years of age.
  • •Patients presenting with increased severity of disease.
  • •Those having serious Comorbidities, including Diabetes, Hypertension.
  • •Pregnant Women those not willing to give consent.

Outcomes

Primary Outcomes

To reduce Virus Clearance Time.

Time Frame: 5 days and 10 days

To improve General Quality of Life.

Time Frame: 5 days and 10 days

To assess role of Ayurveda medicines in the COVID 19 Pandemic management.

Time Frame: 5 days and 10 days

To minimise the chances of Disease progression in terms of Severity.

Time Frame: 5 days and 10 days

To establish Ayurvedic drugs role in National programme for COVID management

Time Frame: 5 days and 10 days

Secondary Outcomes

  • To ascertain role of Ayurveda in the National management of COVID 19 Pandemic(5 days and 10 days)

Investigators

Sponsor
National Health Mission Uttar Pradesh
Sponsor Class
Government funding agency

Study Sites (2)

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