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Safety and efficacy of Ayurvedic Capsule in mild to moderate COVID-19 infection.

A double blind randomized controlled trial to assess safety and efficacy of Cap. IP in COVID-19 positive patients with mild to moderate severity for early recovery, in restoring respiratory health and in improvement in innate immunity

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/07/026570
Enrollment
60
Registered
2020-07-14
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: Cap. IP: Ayurvedic formulation to be taken twice daily in addition to standard of care Control Intervention1: Placebo: Capsule to be taken twice daily in addition to standard of care

Sponsors

AMAI Charitable Trust Pune
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age > 18 years 2.All sexes 3.Case definitions for inclusion in the study will include mild to moderately severe cases as defined in the Guidance on appropriate treatment of suspect/confirmed case of COVI19 issued by Ministry of Health and Family Welfare, Govt of India on 07 Apr 2020. Mild: Cases presenting with fever and/or upper respiratory tract illness (Influenza like Illness, ILI); Moderate: Pneumonia with no signs of severe disease (Respiratory Rate 15 to 30/minute, SpO2 90%-94%). OR 4.Laboratory confirmed SARS CoV-2 infection within last 10 days or SARS CoV-2 test result pending with a high clinical suspicion as defined by: Cough of more than 10 days duration OR 5.Bilateral pulmonary infiltrates on chest X Ray / CT scan or new hypoxaemia defined as SpO2

Exclusion criteria

Exclusion criteria: 1.Pregnant or lactating women 2.Symptoms of acute respiratory tract infection for more than seven days 3.More than 48 hours have elapsed between meeting inclusion criteria and enrolment 4.Subject is also a participant of any other clinical trial 5.Serious / long-standing co-morbid conditions

Design outcomes

Primary

MeasureTime frame
Efficacy of Cap. IP (500 mg) in boosting innate immunity of patients with COVID-19 infection in one months duration.Timepoint: 1 month—

Secondary

MeasureTime frame
Assessing safety of Cap. IPTimepoint: 1 Month;Efficacy of Cap. IP in early recovery of patientsTimepoint: 1 Month;Efficacy of Cap. IP in restoring respiratory healthTimepoint: 1 Month—

Countries

India

Contacts

Public ContactDr Hrishikesh Rangnekar

Quest Clinical Services

sureshpatankar51@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 25, 2026