To Evaluate the Effectiveness of a Whole-System Medicine Approach-Based AIWeLL™ Protocol on Well-Being: A Single-Arm Pre-Post Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 171
- 试验地点
- 1
- 主要终点
- Multi Dimensional Gastrointestinal Symptom Severity Index
研究概览
简要总结
The increasing prevalence of chronicand lifestyle-related health conditions has highlighted the need for acomprehensive, patient-centred approach to well-being. Conventional medicineoften addresses diseases in isolation, focusing on symptom management ratherthan holistic health optimization. Whole-System Medicine (WSM) is anintegrative approach that considers multiple physiological, psychological, andlifestyle factors to improve overall health outcomes. This study aims toevaluate the effectiveness of a WSM-based intervention on well-being through astructured, stratified wellness protocol.
Research Question: Can a Whole-SystemMedicine approach, tailored to individual wellness needs (gastric, metabolic,and women’s wellness), improve health outcomes as measured by symptom-basedassessments, biomarkers and gut microbiome composition?
Justification for the Study:
There is a growing body of evidencesuggesting that whole-system, integrative interventions encompassing nutrition,lifestyle modifications, personalized supplementation, and mind-body practices,can significantly improve health outcomes across various wellness domains.However, most existing research focuses on isolated interventions rather than aholistic, system-based methodology.
This study seeks to address this gapby providing robust evidence on the impact of a Whole-System Medicine approachusing a single-arm pre-post design, assessing outcomes through symptoms,biomarkers and gut microbiome composition. By stratifying participants based onwellness needs, this study aims to offer targeted yet holistic interventionsthat align with personalized health optimization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 25.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants must meet the following general criteria before stratification:
- •Adults aged 25–55 years, of any gender
- •Active smartphone users
- •Presence of non-severe, non-life-threatening health concerns related to gastric, metabolic, or women’s wellness.
- •Willingness to follow the prescribed Whole-System Medicine (WSM) protocol, including dietary, lifestyle, and mind-body interventions.
- •Ability to provide informed consent and comply with study procedures.
- •No surgical procedures or hospital admissions in the last six months
- •No regular use of prescription medications, over-the-counter drugs, or supplements within 2 weeks prior to screening.
排除标准
- •Participants will be excluded if they meet any of the following:
- •Who do not fall under the set cutoffs of Gastric, Metabolic, Women’s Wellness Group
- •Diagnosis of severe acute or chronic illness requiring urgent or intensive medical care.
- •Pregnant or breastfeeding women.
- •Use of immunosuppressive therapy or active malignancies.
- •History of major psychiatric disorders that may affect adherence to the intervention.
- •Participation in another clinical study within the past three months.
- •Patients with prediabetes, diabetes.
- •History of substance abuse (e.g., alcohol, tobacco, recreational drugs)
- •Occurrence of myocardial infarction, stroke, or angina within the last 3 months prior to enrolment.
结局指标
主要结局
Multi Dimensional Gastrointestinal Symptom Severity Index
时间窗: Before and after treatment
Waist circumference BMI
时间窗: Before and after treatment
Womens Health Questionnaire
时间窗: Before and after treatment
次要结局
- Complete Blood Count (CBC), Urine Routine(Bilirubin, SGOP, SGPT, LFT, Serum amylase, lipase, lipid profile)