To Evaluate the Effectiveness of a Whole-System Medicine Approach-Based AIWeLL™ Protocol on Gastric, Metabolic & Women’s Disorders: A Single-Arm Pre-Post Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 171
- 试验地点
- 1
研究概览
简要总结
The increasing prevalence of chronic and lifestyle-related health conditions has highlighted the need for a comprehensive, patient-centred approach to well-being. Conventional medicine often addresses diseases in isolation, focusing on symptom management rather than holistic health optimization. Whole-System Medicine (WSM) is an integrative approach that considers multiple physiological, psychological, and lifestyle factors to improve overall health outcomes. This study aims to evaluate the effectiveness of a WSM-based intervention on well-being through a structured, stratified wellness protocol.
Research Question: Can a Whole-System Medicine approach, tailored to individual wellness needs (gastric, metabolic, and women’s wellness), improve health outcomes as measured by symptom-based assessments, biomarkers and gut microbiome composition?
Justification for the Study: There is a growing body of evidence suggesting 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 a holistic, system-based methodology.
This study seeks to address this gap by providing robust evidence on the impact of a Whole-System Medicine approach using a single-arm pre-post design, assessing outcomes through symptoms, biomarkers and gut microbiome composition. By stratifying participants based on wellness needs, this study aims to offer targeted yet holistic interventions that align with personalized health optimization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 18–60 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
- •Occasional use of over-the-counter drugs or dietary supplements is allowed, provided they do not significantly affect primary outcomes.
排除标准
- •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.
- •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.
研究者
Dr R C Satish Kumar
Bheshaja Ayurveda Clinic