Enhancing protective action of COVID-19 vaccine by using Ashwagandha

A study of Ashwagandha administration in participants vaccinated against COVID-19 on safety, immunogenicity, and protection: A randomized, double blind, placebo controlled, multi-centric clinical trial - AYUSH-AG-VAC-01

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/06/034496

Enrollment

1200

Registered

2021-06-30

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

None listed

Interventions

Intervention1: Ashwagandha: Ashwagandha Tablet 500mg (aqueous extract equivalent to 4 grams Ashwagandha root powder) once daily For 24 Weeks Control Intervention1: Placebo: Placebo tablet [containing

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy volunteers of either sex aged 18-65 years who have received either the first or second dose of COVID-19 vaccine or have received the booster dose as per the Government policy . Healthy volunteers defined as someone with no known significant health problems 2.SARS-COV-2 RT-PCR negative volunteers 3. Written informed consent by participants 4. The participant willing to comply with study protocol requirements 5. Female participants of childbearing potential must have a negative urine pregnancy test

Exclusion criteria

Exclusion criteria: 1.Any known co-morbidity or acute illness with or without symptoms at the discretion of the investigator 2.. History of any known hypersensitivity to any component of study material (Ashwagandha). 3. Any confirmed or suspected condition with impaired/altered function of immune system or possible risk suggested by investigations (e.g. increased levels of D-dimer) 4. Women who are breast-feeding and pregnant 5. Individuals who are using any intervention (AYUSH or other interventions) for prophylaxis or for immune boosting or that may influence immune system e.g. steroids, methotrexate, anti-rheumatoid agents, drugs from AYUSH systems within 30 days prior to screening 6. Individuals who have received systemic immunoglobulins or blood products within 3 months prior to screening

Design outcomes

Primary

Measure	Time frame
Immunogenicity as measured by SARS-CoV-2 spike (S1) and RBD-specific IgG antibody titresTimepoint: Baseline (Day1),4 weeks, 8 weeks, 12 weeks,16 weeks, 24 weeks and 28 weeks	—

Secondary

Measure	Time frame
1)Safety by Incidence of adverse events 2) Protective immune response measured by (i) SARS-CoV-2 specific neutralizing antibody titer (spike protein and nucleocapsid) and Serum Neutralization Titer, and its duration (sustenance) (ii)percent seroconversion after each vaccine dose (iii) incidence of SARS-CoV-2 breakthrough infections (RT PCR positive) after each vaccination dose 3)Quality of life measured using WHO QOL-BREF and Health Related Behavior Habit Fitness (CRD Pune 2020 version) Timepoint: 4 weeks, 8 weeks, 12 weeks,16 weeks, 24 weeks and 28 weeks	—

Measure

Time frame

1)Safety by Incidence of adverse events 2) Protective immune response measured by (i) SARS-CoV-2 specific neutralizing antibody titer (spike protein and nucleocapsid) and Serum Neutralization Titer, and its duration (sustenance) (ii)percent seroconversion after each vaccine dose (iii) incidence of SARS-CoV-2 breakthrough infections (RT PCR positive) after each vaccination dose 3)Quality of life measured using WHO QOL-BREF and Health Related Behavior Habit Fitness (CRD Pune 2020 version) Timepoint: 4 weeks, 8 weeks, 12 weeks,16 weeks, 24 weeks and 28 weeks

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Countries

India

Contacts

Public ContactDr N Srikanth

Savitribai Phule Pune University

bpatwardhan@gmail.com09689766399

Outcome results