Clinical study on NC009 Biscuits as an immunity enhancer in healthy individuals
- Registration Number
- CTRI/2021/11/037971
- Lead Sponsor
- BRITANNIA R and D CENTRE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 608
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method