Efficacy and Tolerability of Pure Peppermint Herbal Tea on Overall Digestion 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
- 60
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of Pure Peppermint Herbal Tea in improving overall digestion compared to normal tea
研究概览
简要总结
Eligible participants will undergo a screening visit to confirm inclusion/exclusion criteria and obtain baseline data. Participants will be randomly assigned to either the Pure Peppermint Herbal Tea group or the Normal tea group. Subject diary cards will be handed over for documentation of self-reported study endpoints. Participants will consume the assigned tea (Pure Peppermint Herbal Tea or normal tea) twice daily for 60 days. Two telephonic follow-ups will be conducted on Day 7 and Day 28.
Participants will attend two study visits:
Visit 1: Baseline (Day 0) - Informed consent, eligibility assessment, subject diary card (SDC) distribution, baseline data collection (overall digestive and lifestyle (DLQL) score, bowel movement assessment and BSFS scoring, vital signs, concomitant medication.
Visit 2: Completion of 8 weeks – Retrieval of SDC, final assessment of study endpoints captured in SDC, digestive and lifestyle (DQLQ) score, bowel movement assessment and BSFS scoring, vital signs, adverse events and tolerability assessment.
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
- •Healthy adults, both males and females, aged 18 to 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 Peppermint 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 digestion improvement programs during the study period.
排除标准
- •Diagnosis or history of any chronic gastrointestinal disorder, including but not limited to irritable bowel syndrome IBS, inflammatory bowel disease IBD Crohns disease, ulcerative colitis, celiac disease, gastroesophageal reflux disease GERD requires continuous treatment, chronic constipation or diarrhoea, known gastrointestinal motility disorders History of major gastrointestinal surgery excluding appendectomy or cholecystectomy that could significantly alter digestive function Use of prescription medications for digestive health within 2 weeks before screening, including Proton pump inhibitors PPIs, H2 receptor antagonists, Antacids regular, chronic use, Laxatives regular, chronic use, Antidiarrheals regular, chronic use, Prokinetics, Digestive enzymes and Antibiotics Known allergy or sensitivity to peppermint or related plants other members of the Lamiaceae family Pregnant or breastfeeding women, or women planning to become pregnant during the study period Participation in another clinical trial or intervention study within 30 days before screening Uncontrolled diabetes, cardiovascular disease, renal or hepatic impairment, autoimmune disorders, and active infections History of alcohol or substance abuse that, in the opinion of the investigator, could interfere with study compliance or data interpretation.
- •Presence of any unstable psychiatric condition that, in the opinion of the investigator, could interfere with study compliance or data interpretation History of recent or active infectious illnesses common cold, influenza, gastroenteritis within 2 weeks before screening.
结局指标
主要结局
To evaluate the efficacy of Pure Peppermint Herbal Tea in improving overall digestion compared to normal tea
时间窗: Baseline and 8 weeks
次要结局
- To assess the frequency of bowel movements and stool consistency in two treatment groups(To evaluate the safety and tolerability of Pure Peppermint Herbal Tea compared to normal tea)
研究者
Sushavan Sinha
Luxmi Tea Co Private Limited