None listed
Conditions
Interventions
Intervention1: OAHT Immune Boost Tablets: Single tablet to be taken preferably in the morning after breakfast for 2 months.
Control Intervention1: OAHT Immune Boost Tablets (Placebo): Single tablet to
Sponsors
OmniActive Health Technologies
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male or non-pregnant, non-lactating female human subjects between age of � 30 and � 70 years who frequently suffers from cold, flu, and fever. 2. Subjects who smoke and willing to abstain from smoking and consuming tobacco throughout the study duration. 3. Subjects who consume alcohol and willing to abstain from consuming alcohol throughout the study duration. 4. Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation at baseline measurement. 5. Subjects willing to avoid anti-inflammatory/immunostimulant/ immunosuppressant medications during the study period. 6. Female subjects of childbearing potential practicing an approved method of contraception and willing to continue its use throughout the study duration or female subjects of non-childbearing potential. 7. Subjects willing to provide written consent. 8. Subjects shall be willing and able to understand and comply with the requirements of the study, consume the study IP as instructed, return at the appropriate scheduled visits, comply with therapy prohibitions, and be able to complete the study.
Exclusion criteria
Exclusion criteria: 1. History or evidence of hypersensitivity to any ingredient from the formula or its metabolites. 2. Subjects with clinically significant disease(s) or disorder(s) in the opinion of the Investigator may (i) put the subject at risk because of participation in the study (ii) interfere with the study evaluations or (iii) cause concern regarding subjectââ?¬•s ability to participate in the study. 3. History of hypo and hyperthyroidism. 4. Presence of alarm signs or symptoms, including fever, gastrointestinal bleeding, unintentional weight loss, anemia, dysphagia, or abdominal mass. 5. History of milk, gluten allergies, or other known food intolerances and/or any food allergies. 6. History of significant systemic diseases, seizures, psychiatric disorders, neurological disorders, depression, or mental illness and allergic rash. 7. Subjects taking ace-inhibitors, cholesterol-lowering medications. 8. History of difficulty with donating blood or difficulty in the accessibility of veins. 9. Receipt of any prescription drugs or over-the-counter drugs (e.g.: cough and cold preparations, antacid preparations and natural products used for therapeutic benefits) within 30 days before screening. 10. Current use of an immunostimulant/immunosuppressant supplement. 11. Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period. 12. Female subjects with positive Urine Pregnancy Test at the screening. 13. Subjects who have been treated with any investigational drug or investigational device within 3 months before study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢ Mean change from baseline on immunity as determined by laboratory parameters ââ?¬Â¢ Mean change from baseline on stress as determined by Perceived Stress Scale ââ?¬Â¢ Mean change from baseline on sleep as determined by PSQI Timepoint: ââ?¬Â¢ Baseline (Visit 1), 4 weeks (Visit 2) and 8 weeks (Visit 3) ââ?¬Â¢ Visit 1 (Baseline), Visit 2 (4 weeks) and Visit 3 (8 weeks) ââ?¬Â¢ Visit 1 (Baseline), Visit 2 (4 weeks) and Visit 3 (8 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| nilTimepoint: nil | — |
Countries
India
Contacts
Public ContactDr D Sathish Kumar
G7 Synergon Private Limited
Outcome results
None listed