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Evaluation of Efficacy and Safety of Ayurveda Intervention (Ayush -64) in the management of COVID-19 infection (Asymptomatic &Mild to Moderate symptoms

Evaluation of Efficacy and Safety of Ayurveda Intervention (Ayush -64) in the management of COVID-19 infection (Asymptomatic &Mild to Moderate symptoms)- An open label single arm prospective clinical trial

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/05/025338
Enrollment
40
Registered
2020-05-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: Ayush 64: Dose: 2 Tablets(500 mg each) thrice daily (2-2-2) Dosage form: Tablets Route of Administration: Oral Time of Administration: Thrice a day after food Anupana: Warm Water

Sponsors

Central Council For Research in Ayurvedic Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Asymptomatic, Mild to moderate cases registered in A & U, Tibia hospital above 18-60 years of age, with COVID 2019 (Confirmed by RT-PCR or Rapid Antigen Test) quarantined at identified hospital set up. 2.Participants who can take medicines orally 3.Patients willing to provide signed informed consent

Exclusion criteria

Exclusion criteria: 1.Cases of severe vomiting which would make oral administration of medicine difficult. 2.Cases of respiratory failure and requiring mechanical ventilation. 3.Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 2 times the upper limit of normal. 4.Patients with COVID 19 in critical condition or ARDS or NIAD 8 â??point ordinal score 2 Hospitalized, on invasive mechanical Ventilation or extra corporeal membrane oxygenation 5.Pregnant or lactating women 6.Any other condition, which as per the investigator would jeopardize the outcome of the trial.

Design outcomes

Primary

MeasureTime frame
1.Negative status of SARS-CoV-2 on nasal or throat swab after 07 days or 14 days of intervention in a 2 day continuous real time RT-PCR test. 2. Changes in liver enzymes, Renal functionsTimepoint: 1.Negative status of SARS-CoV-2 on nasal or throat swab after 07 days or 14 days of intervention in a 2 day continuous real time RT-PCR test. [Time frame: 8th day or 15th day] 2. Changes in liver enzymes, Renal functions [Time frame: 8th day or 15th day]

Secondary

MeasureTime frame
1.Mean time (days) for clinical recovery as per clinical recovery criteria defined. 2.Number of symptomatic patients showing â??clinical recoveryâ??. Improvement in selected laboratory parameters:, differential and total leukocyte counts, acute phase reactants, serum IL-6, Serological Protective Antibody Assay (IgE ,IgM and IgG).Timepoint: 1.Mean time (days) for clinical recovery as per clinical recovery criteria defined. [time frame:7th day,14th day if RTPCR positive-on 8th or 9th Day] Time frame: 8th day or 15th day 2.Time frame: 8th day (after intervention of 7 days) or 15th day( in case intervention for 14 days).

Countries

India

Contacts

Public ContactDr Shivshankar Rajput

CCRAS

drbabitayadav@gmail.com9910171143

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026