None listed
Conditions
Interventions
Intervention1: One 380 mg TolerGenTM Capsule: Consume orally once a day after breakfast for 90 days.
Control Intervention1: One 380 mg placebo capsule: Consume orally once a day after breakfast for 9
Sponsors
PhytoVeda Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female participants aged between 40 and 70 years both inclusive. 2.Individuals whose blood leukocyte count, a key indicator of immune function, is neither low 3 4 10 per microLiter nor excessively high 8 10 10 per microLiter. 3.Individuals with IgG levels within the range of 600 1600 mg per dL that is within normal range both inclusive. 4.Individuals who have experienced symptoms of upper respiratory tract infection for example cold, tonsillitis, pharyngitis, laryngitis, sinusitis, otitis media, rhinitis, at least twice within one year before screening. 5.An immune status questionnaire score of less than 6. 6.Reporting two or more gut health-related symptoms, including bloating, abdominal pain, diarrhea, constipation, or abdominal discomfort. 7.Not currently taking any other immune-boosting health supplements or functional foods. 8.Able and willing to comply with all study procedures and the intervention regimen. 9.Participants willing to participate in clinical trials and who have read, understood and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Participants who are unable to take the investigational product orally or as prescribed. 2.Participants over the age of 70 or those with known intolerance or allergy to the investigational product or its components. 3.Individuals with cardiovascular disease, myocardial infarction, angina, heart failure, arrhythmia or a history of pacemaker use. 4.Individuals with liver disease, kidney disease, lung or respiratory disease. 5.Individuals with gastrointestinal diseases Crohn es disease history of gastrointestinal resection, or irritable bowel syndrome. 6.Individuals with thyroid disease or abnormal symptoms. 7.Individuals with autoimmune disease, inflammatory systemic disease, metabolic syndrome or any infectious diseases. 8.Individuals with any type of malignancy, including leukemia. 9.Individuals with neurological or psychiatric disorders for example depression, schizophrenia or a history of psychotherapy. 10.Individuals with diabetes, hypertension, or any musculoskeletal disorders. 11.Individuals who have undergone surgery within the past six months. 12.Females who are pregnant, breastfeeding, within six months postpartum, planning pregnancy, or not using reliable contraception. 13.Individuals engaged in high intensity exercise and willing to continue throughout the study. 14.Individuals who have used immunosuppressants, antibiotics, non-steroidal anti-inflammatory drugs NSAIDs, steroids, or antihistamines within the past 3 months, and have received any vaccination during the same period. 15.Individuals with a history of drug addiction. 16.Individuals who consume alcohol exceeding 30 g per day approx. 3 glasses of beer for men or 20 g per day approx. 2 glasses of beer for women. 17.Participants who have received probiotic or fiber-based treatments within the past 6 months. 18.Individuals who have experienced any severe stressful life events within four weeks before the study. 19.Individuals who have participated in another clinical trial within the past three months. 20.Any other condition, as determined by the investigator, that may render the participant unfit for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Changes in NK Cell activity, assessed using the % NK cell activity assay at baseline and Day 90. 2.Changes in immune cell profile, including CD3, CD4, CD4/CD8 ratio, T cells, B cells, and monocytes.Timepoint: 1.At baseline and Day 90. 2.At baseline and Day 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Evaluate the effects of TolerGen supplementation on serum, salivary, and fecal immune biomarkers inflammatory and immunomodulatory markers gastrointestinal symptoms anxiety and sleep quality and overall health status, including cold incidence and related outcomes. 2.Assess safety through clinical laboratory tests and adverse event monitoring, as well as to evaluate participant compliance and tolerability. 3.Evaluate the effects of TolerGenTM capsule supplementation on gastrointestinal symptoms, anxiety levels, sleep quality, and clinical laboratory parameters.Timepoint: 1.From Screening to end of the Study. 2.From Screening to end of the study. 3.From Screening to end of the Study. | — |
Countries
India
Contacts
Public ContactDr Siddharth J Modi
PhytoVeda Pvt. Ltd.
Outcome results
None listed