None listed
Conditions
Interventions
Intervention1: Turmeric Spice Herbal Tea: Turmeric Spice Herbal Tea: Serving Size- 2g (tea bag) in 150 ml hot water, 5 mins brewing at about to boil water.
Recommended consumption: One cup (150 ml) of
Sponsors
Luxmi Tea Co Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Healthy adults, both males and females, aged 18 to 65 years, both inclusive, at the time of screening. Willing and able to provide written informed consent before any study related procedures. This ensures that participants understand the study purpose, procedures, risks, and benefits and that their participation is voluntary. Participants must be daily tea taker, Participants willing and able to comply with all study procedures, including daily consumption of the assigned tea Turmeric Spice Herbal Tea or Normal tea prepared as per direction provided and continuing for the duration of the study, Participants willing to attend scheduled study visits, and completing all required questionnaires. Access to a telephone and the ability to be contacted by study personnel Agreement to maintain a stable diet throughout the study period Day 0 to Completion of 8 weeks of drinking tea and not undertake any major dietary changes Agreement to refrain from starting any new herbal supplements or making significant dietary changes defined as a substantial alteration in macronutrient intake or the introduction of restrictive diets during the study period. Agreement to discontinue the use of any other immune modulating interventions for at least 2 weeks before enrolment and throughout the study duration. Participants should not be enrolled in any other trials. or planned surgery during the study period.
Exclusion criteria
Exclusion criteria: Use of immunosuppressant medications methotrexate, azathioprine, cyclosporine or systemic corticosteroids prednisone within 3 months before enrollment. Inhaled or topical corticosteroids are permitted. Pregnant or breastfeeding women Participation in other clinical trials Participation in another interventional clinical trial within 30 days before enrollment. Observational studies are permitted. Regular use more than 3 times per week of immunomodulatory supplements, such as Echinacea, Elderberry, and High dose vitamin C more than 1000 mg daily, Vitamin D more than 4000 IU daily, and Zinc more than 50 mg daily. History of clinically significant liver or kidney disease, as determined by medical history and or elevated liver enzymes or creatinine levels during screening. Known bleeding disorders hemophilia, von Willebrand disease or regular use of anticoagulant medications warfarin, heparin, direct oral anticoagulants. Subjects with uncontrolled diabetes Subjects who received vaccination for Influenza within the last 3 months Subjects judged ineligible by the investigator Subjects with a heart condition, malignant tumor, myocardial infarction, with a pacemaker or implantable cardioverter defibrillator ICD Subjects who had undergone surgery in the last 2 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Turmeric Spice Herbal Tea in improving overall immunity compared to normal teaTimepoint: Baseline and 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the rate of infections and the duration of infection in subjects consuming Turmeric Spice Herbal Tea compared to normal tea To assess the safety and tolerability of Turmeric Spice Herbal Tea compared to normal teaTimepoint: Baseline and 8 weeks | — |
Countries
India
Contacts
Public ContactSushavan Sinha
Luxmi Tea Co Private Limited
Outcome results
None listed