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To observe the effect of Ayurvedic medicine (Ashwagandha and Shunti) for the treatment of COVID-19

A Prospective Randomized Controlled Clinical Trial to evaluate the Efficacy and Safety of Ayurveda Interventions (Ashwagandha Tablet and Shunti Capsule) in the management of COVID-19 infection (Mild to Moderate symptoms)

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/08/027224
Enrollment
60
Registered
2020-08-18
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: Ashwagandha tablet and Shunti capsule: a. Ashwagandha Tablet Dose: 2 Tablets 250mg each( twice daily) Dosage form: Tablets Route of Administration:Oral Time of Administration: Twice a

Sponsors

Central Council for Research in Ayurvedic Sciences New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Mild to moderate cases registered in the Hospital, with COVID 2019 (Confirmed by Antigen test/ RT-PCR) quarantined at identified hospital set up. 2. Participants who can take medicines orally 3. Patients with either sex, 18 to 75 years age 4. 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. Patients with hyperacidity and gastric ulcer to be excluded. 3. Chronic, Severe, Unstable, Uncontrolled co-existent medical illness such as Diabetes, Hypertension, Cardiac disorders, kidney disorders and lung disorders or other disease of concern which may put the patient at increased risk during the study 4. Cases of respiratory failure and requiring mechanical ventilation. 5. 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 6. Pregnant or lactating women 7. Any patient with proved sensitivity to the trial drugs may be excluded. 8. Any other condition, which as per the investigator would jeopardize the outcome of the trial.

Design outcomes

Primary

MeasureTime frame
1. Clinical cure rate: Time to negative conversion of severe acute respiratory syndrome corona-virus 2.(From the day of randomization)Timepoint: On 7th day and 15th day

Secondary

MeasureTime frame
1. Duration of fever and each of the respiratory symptoms. 2. Improvement in hematological and laboratory parameters (CBC, LFT, RFT, Lipid profile, FBS, ESR, Hs-CRP, LDH, S. Ferritin, D-dimer, TNF-α, IL-6, Serum IgG for COVID-19, Serum IgM for COVID-19, RT-PCR and HRCT Chest Scan). 3. No of cases reporting any ADR/AE. 4. Number of patients referred due to progressing/worsening of disease. 5. Number of cases that required invasive or non-invasive oxygen therapy during the intervention. Timepoint: On 7th day and 15th day

Countries

India

Contacts

Public ContactDr Sumit Shrivastva

Shri Dhanwantry Ayurvedic College and Hospital

sumitpankaj@gmail.com9781110780

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 8, 2026