None listed
Conditions
Interventions
Intervention1: NC009 Biscuits: contains Wheat flour, Oats, Sugar, Pumpkin seeds, Flax seeds, Chia seeds, Vitamins and Minerals , Ashwagandha Ext, Tulsi Extract, Amla Ext, Turmeric Ext, Giloy Ext. and
Sponsors
BRITANNIA R and D CENTRE
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy subjects (for 18 years and above) who have taken at least one dose of COVID-19 vaccine. 2. 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 4. Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis and Cancer etc. 5. Subjects taking steroid treatment and or any kind of immunosuppressive therapy 6. Subjects participating in any other clinical study or having participated in any other study 3 months prior to screening in the present study. 7. Subjects having a past history of allergy to Biscuits like products 8. 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 disorders over a period of 6 months (180 days) against placebo controlTimepoint: Screening visit (Day up to 5) , Day 0, Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Comparative difference in severity of infections against control. 2.Comparative assessment based on severity and number of subjects suffering from infections along with number of episodes. 3.Comparative difference in incidence and severity of other allergy related health problems against control. 4.Comparative assessment of number of subjects suffering from other allergy related health problems and number of episodes and duration of episodes against control. 5.Comparative overall changes in general physical health, neurocognitive health, energy levels, strength and stamina against control. 6.Comparative difference in quality of life against control 7.Comparative difference in global assessment of overall change as per the investigator against control. 8.Comparative difference in immunity and inflammatory related bio-markers against control. 9.Assessment of AE,SAE against control. Timepoint: Screening visit (Day up to 5) , Day 0, Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research
Outcome results
None listed