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Efficacy and safety of AYUSH 64 tablets in treating mild to moderate Covid 19 patients

A Randomized, Open Label, Parallel Efficacy, Active Control, Exploratory Clinical Trial to Evaluate Efficacy and Safety of an Ayurvedic Formulation (AYUSH 64) as Adjunct Treatment to Standard of Care for the management of Mild to Moderate COVID-19 Patients

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/07/026705
Enrollment
80
Registered
2020-07-20
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: B342- Coronavirus infection, unspecified

Interventions

Intervention1: Group I : (Ayurveda as add-on to standard care as per: guidelines) AYUSH 64 Dose 2 capsules (500 mg each) thrice daily Dosage form Capsules/Tablets Route of Administration Oral Tim

Sponsors

Central council for research in Ayurveda and Siddha
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Typical clinical presentation of acute onset febrile illness with sore throat and dry cough with or without shortness of breath and a RT_PCR based laboratory confirmation test for COVID-19 2. Patients presenting with or without Typical clinical presentation but having RT_PCR based laboratory confirmation test for COVID-19 3. Patients with either sex, 18 to 75 years age 4. Patients with mild-moderately severe disease 5. All patients must agree not to share medication 6. Patients willing to participate and sign an informed consent Understands and agrees to comply with planned study procedures. 7. Agrees to the give OP swabs and venous blood for testing as per protocol

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
a) Mean time (days) for clinical recovery [Day of randomization to the day of clinical recovery (see criteria below)] b) Proportion of patients showing â??clinical recoveryâ?? Timepoint: 7-15-30 days

Secondary

MeasureTime frame
1. Percentage of patients with negative SARS-CoV-2 on nasal or throat swab in a 2-day continuous real time RT-PCR test 3. Proportion of patients developing an event that reflects clinical or otherwise improvement of worsening 5. Improvement in selected laboratory parametersTimepoint: 7-15-30 days

Countries

India

Contacts

Public ContactDr Nataraj H R

Shri Dharmasthala manjunatheshwara college of Ayurveda Hassan

drnatarajhr@sdmcahhassan.org09844849192

Outcome results

None listed

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