None listed
Conditions
Interventions
Intervention1: Pure Dandelion Herbal Tea: Pure Dandelion Herbal Tea: Serving Size- 2g in 150 ml hot water, 5 mins brewing in about to boil water temp.
Recommended consumption: Consumption of one cup o
Sponsors
Luxmi Tea Co Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Males and females aged between 18 and 65 years, inclusive Generally healthy individuals, as determined by medical history and physical examination Experiencing occasional digestive discomfort bloating, gas, indigestion, abdominal discomfort, altered bowel habits, dyspepsia with little or no pain at least once a week for the past one month before screening Stable health status for at least 3 months before screening visit 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, willing and able to comply with all study procedures, including daily consumption of the assigned tea Pure Dandelion Herbal Tea or Normal tea prepared as per direction provided and continuing for the duration of the study, attending scheduled study visits, and completing all required questionnaires and subject diaries. Access to a telephone and the ability to be contacted by study personnel Ability to communicate effectively with study personnel Agreement to maintain a stable diet throughout the study period Day 0 to 8 weeks and not undertake any major dietary changes Agreement to refrain from starting any new exercise programs or significantly altering physical activity levels during the study period Willingness to abstain from other herbal supplements, teas, or detoxification programs during the study period Agreement to limit alcohol consumption to no more than 2 standard drinks per day for males and 1 standard drink per day for females throughout the study period Agreement to maintain stable caffeine consumption throughout the study period
Exclusion criteria
Exclusion criteria: History or presence of clinically significant liver disease History or presence of clinically significant kidney disease History or presence of gastrointestinal disorders that could significantly affect digestion or bowel habits inflammatory bowel disease, Crohns disease, ulcerative colitis, celiac disease, irritable bowel syndrome requiring regular medication History of gastrointestinal surgery that may affect absorption Uncontrolled diabetes mellitus History of cardiovascular disease myocardial infarction, stroke, heart failure, unstable angina within 6 months before screening Uncontrolled hypertension History of malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer Presence of any condition that, in the investigators opinion, would compromise the subject safety or compliance, or interfere with the interpretation of study results Known allergy or hypersensitivity to dandelion or other plants History of severe allergic reactions or anaphylaxis to any food or drug Use of prescription medications known to affect liver function, kidney function, digestion, or bowel habits, unless the medication has been stable for at least 3 months before screening and is expected to remain stable throughout the study period Use of any over the counter medications or supplements known to affect liver function, kidney function, digestion, or bowel habits within 30 days before screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Pure Dandelion Herbal Tea compared to normal tea in improving overall detoxificationTimepoint: Baseline and 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effect of Pure Dandelion Herbal Tea on sleep quality compared to normal tea To explore the changes in general well-being and quality of life in participants consuming Pure Dandelion Herbal Tea compared to normal tea To evaluate the safety and tolerability of Pure Dandelion 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