Efficacy and Tolerability of Pure Dandelion Herbal Tea on Overall Detoxification in Healthy Adults: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of Pure Dandelion Herbal Tea compared to normal tea in improving overall detoxification
研究概览
简要总结
Eligible participants will undergo screening, informed consent, and baseline data collection. At the baseline visit (Day 0), participants will receive a subject diary card (SDC) to record weekly urine output (frequency, colour, and volume), bowel movement frequency, and stool consistency [(utilizing Bristol Stool Form Scale (BSFS)], and complete the World Health Organization-Five Well-being Index (WHO-5) and Pittsburgh Sleep Quality Index (PSQI) questionnaires. They will then be randomized to Pure Dandelion Herbal Tea or normal tea. Participants will be instructed to for preparation of tea and consume one cup (150 mL) of the assigned tea twice daily for 8 weeks. There will be telephonic follow-up at Day 7 and Day 28. Final visit on completion of 8 weeks will include reviews of SDC to assess changes in urine output, bowel frequency, and stool consistency. The final visit on completion of 8 weeks will also include assessment through WHO-5 and PSQI questionnaires to check any changes in well-being and sleep quality, respectively. Adverse events and adherence to study instructions will be assessed for the entire study period utilizing the self-reported SDC and clinical evaluation (as applicable). Data will be analysed to compare changes in urine output, bowel frequency, stool consistency, WHO-5 scores, PSQI scores, and adverse event incidence between groups from baseline to 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
To evaluate the efficacy of Pure Dandelion Herbal Tea compared to normal tea in improving overall detoxification
时间窗: Baseline and 8 weeks
次要结局
- 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)
研究者
Sushavan Sinha
Luxmi Tea Co Private Limited