A clinical trial to evaluate the medicinal efficacy and safety of Ayurvedic kit in COVID-19 positive Patients.

EFFICACY AND SAFETY OF â??AYUR RAKSHA KITâ?? IN MILD COVID-19 PATIENTS AT A TERTIARY CARE HOSPITAL: AN OPEN-LABEL, RANDOMIZED CONTROL STUDY

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/08/027283

Enrollment

Registered

2020-08-20

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: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: Ayur Raksha kit: Ayur Raksha Capsules 500 mg QID and Ayur Raksha Choorna 4 grams QID for 7 days Control Intervention1: Standard treatment: Covid-19 positive patients receiving standard

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients willing to give written informed consent 2. Patients of either sex aged between 18 and 60 years. 3. Patients diagnosed with COVID-19 positive (confirmed by RT-PCR) Mild symptomatic patients (Patients with uncomplicated upper respiratory tract infection) such as: SpO2: >=94% in room air RR: No evidence of hypoxemia or breathlessness

Exclusion criteria

Exclusion criteria: 1.Patients who is not willing to give consent for the study. 2.Patients who has uncontrolled comorbidities like Diabetes, Hypertension and heart diseases. 3.Patients with pre-existing respiratory conditions, renal and liver diseases. 4.Immunocompromised individuals/those on immunosuppressants. 5.Female patients who are pregnant/ lactating or considering pregnancy. 6.Psychiatric or emotional disturbance in patients which would limit ability of the patients to comply.

Design outcomes

Primary

Measure	Time frame
1.Number of patients achieving Virological cure 2.Time to achieve Virological cure Virological cure is defined as RT-PCR turning negativeTimepoint: Day 1 baseline assessment Day 3 Telephonic follow-up will be done for improvement in symptoms and Side-effects Day 7 Telephonic assessment with RT-PCR will be done Day 10 Telephonic assessment with Total count and differential count of WBCs, D-dimer, CRP, Derived Neutrophil to Lymphocyte Ratio: d-NLR will be done	—

Measure

Time frame

1.Number of patients achieving Virological cure 2.Time to achieve Virological cure Virological cure is defined as RT-PCR turning negativeTimepoint: Day 1 baseline assessment Day 3 Telephonic follow-up will be done for improvement in symptoms and Side-effects Day 7 Telephonic assessment with RT-PCR will be done Day 10 Telephonic assessment with Total count and differential count of WBCs, D-dimer, CRP, Derived Neutrophil to Lymphocyte Ratio: d-NLR will be done

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Secondary

Measure	Time frame
1 Number of patients achieving Clinical cure 2 Time to achieve Clinical cure 3 Improvement in WBC count, D-dimer, CRP, d-NLR from admission to day 10. 4 Number and severity of adverse events Clinical cure is defined as- one or more of the following: -Continuous decrease in temperature/attaining normal temperature (normal temperature rate axillary 97.8 degree F) -Respiratory rate 20/min -Oxygen saturation 98 % without oxygen supplementation -No coughTimepoint: Day 1-Baseline assessment Day 3-Telephonic follow-up will be done for improvement in symptoms and Side-effects Day 7-Telephonic assessment and RT-PCR will be done Day 10-Telephonic assessment with Total count and differential count of WBCs, D-dimer, CRP, Derived Neutrophil to Lymphocyte Ratio (d-NLR) will be done	—

Measure

Time frame

1 Number of patients achieving Clinical cure 2 Time to achieve Clinical cure 3 Improvement in WBC count, D-dimer, CRP, d-NLR from admission to day 10. 4 Number and severity of adverse events Clinical cure is defined as- one or more of the following: -Continuous decrease in temperature/attaining normal temperature (normal temperature rate axillary 97.8 degree F) -Respiratory rate 20/min -Oxygen saturation 98 % without oxygen supplementation -No coughTimepoint: Day 1-Baseline assessment Day 3-Telephonic follow-up will be done for improvement in symptoms and Side-effects Day 7-Telephonic assessment and RT-PCR will be done Day 10-Telephonic assessment with Total count and differential count of WBCs, D-dimer, CRP, Derived Neutrophil to Lymphocyte Ratio (d-NLR) will be done

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Countries

India

Contacts

Public ContactDr BHAVYA DARSHINI M

BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE

bmccrj@gmail.com9448292424

Outcome results

None listed

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