None listed
Conditions
Interventions
None listed
Sponsors
Ixoreal Biomed
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult males and females between 18 to 60 years of age. (Apparently healthy, as determined by medical history, physical examination) 2. Subjects with Immune Status Questionnaire of less than 6 3. Participants who agree to take investigational product (i.e., Till day 56) 4. Literate subject willing to give signed informed consent. 5. Willing to comply with study protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Participants who are not willing to take investigational product. 2. Any acute illness which may hamper the study participation as per PI discretion at the time of enrollment. 3. Individual participating in any other studies, including macro/micro/any other forms of dietary supplements/multivitamins or disease-specific oral nutrition supplements. 4. Patients with uncontrolled, unstable comorbidities. 5. Individuals with pre-existing respiratory conditions or diagnostic history with chronic lung disease, active malignancy, chronic kidney disease, chronic liver disease. 6. History of allergic reactions or anaphylaxis to investigational product components. 7. Participants with a history of or those currently on immunosuppressants. 8. Pregnant and lactating females. 9. Any other condition which the principal investigator thinks may jeopardize the safety of subjectsâ??patients with uncontrolled, unstable comorbidities. 10. Those with a history of clinically significant hypersensitivity reactions to immunomodulators. 11. Those with thyroid or pituitary disease 12. Those with immune system disease 13. Those with a history of systemic diseases such as multiple sclerosis, allergic skin disease and other autoimmune diseases 14. Those with a BMI of less than 18.5 kg/m2 at screening 15. Those who have received antipsychotic medication within 2 months before screening 16. Those with a alcoholism or history of substance abuse 17. Fertile women who do not accept the appropriate method of contraception (except for women who have undergone sterilization operation) 18. Participation in a clinical study during the preceding 90 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean levels of Serum Immune Biomarkers (NK Cell, CD4, CD8-T-Lymphocytes)Timepoint: Baseline and Day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢Change in mean levels of Serum Immune Biomarkers (IgA, IgG, IL-6, Interferon-Gamma, TNF-alpha levels) from baseline to end of study. (Time Frame: Baseline, Day 56) â?¢Number of Individuals displaying the improvement of Immune Health Status (questionnaire) between the groups. (Time Frame: Baseline, Day 56) â?¢Mean change in QoL status as determined by SF-12 (QoL) questionnaire from baseline to end of study. (Time Frame: Baseline, Day 56) â?¢Number of AEs between groups. (Time Frame: Baseline, Day 56) â?¢ Perceived Stress Scale-10 (Time Frame: Baseline, Day 56) â?¢Patientâ??s Global Assessment of Tolerability to Therapy (PGATT) Timepoint: Baseline and Day 56 | — |
Countries
India
Contacts
Public ContactMr Sohal Pendse
ProRelix Services LLP
Outcome results
None listed