None listed
Conditions
Interventions
None listed
Sponsors
Lupin Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy individuals 2. Subjects (for 18 years and above) who have taken at least one dose of COVID-19 vaccine. 3. Subjects who are ready to provide written informed consent and who are ready to willingly participate and follow the protocol requirements of the clinical study.
Exclusion criteria
Exclusion criteria: 1. Pregnant and Lactating females 2. Subjects who have been confirmed of having COVID-19 and have been isolated for its treatment. Subjects having recently (3 months) suffered and recovered of COVID-19 will also be excluded from the study 3. Known cases of Diabetes 4. Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening 5. Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis and Cancer etc. 6. Subjects taking steroid treatment and or any kind of immunosuppressive therapy 7. Subjects participating in any other clinical study or having participated in any other study 3 months prior to screening in the present study. 8. Subjects having a past history of allergy to Beone Capsule or any of its ingredients 9. Other conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparative difference in incidence of infections, and allergy related disordersTimepoint: Screening Visit (Up to day 5), Baseline/ Randomization Visit (Day 0), Visit 1 (Day 30), visit 2 (Day 60), Visit 3 (Day 90) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparative difference in severity of infections (when it occurs) 2. Comparative overall changes in general physical health, neurocognitive health, energy levels, strength and stamina 3. Comparative assessment of onset and duration of action for change in energy levels 4. Comparative difference in number of subjects requiring hospitalization, number of days of hospitalization etc. 5. Comparative difference in NK cells, IL6 and CRP levels 6. Comparative difference in incidence and severity of other allergy related health problems. 7. Comparative assessment of number of subjects suffering from other allergy related health problems and number of episodes and duration of episodes 8. Comparative difference in quality of life based on WHO-QOL BREF 9. Comparative difference in global assessment of overall change as per the investigator. 10. Assessment of AE/SAE including vitals 11. Assessment of pre and post-study product consumption safety laboratoryTimepoint: Screening Visit (Up to day 5), Baseline/ Randomization Visit (Day 0), Visit 1 (Day 30), visit 2 (Day 60), Visit 3 (Day 90) | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt. Ltd.
Outcome results
None listed