To Evaluate the Effectiveness of a Whole-System Medicine Approach-Based AIWeLL DM™ Protocol on Diabetes: A Single-Arm Pre-Post Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 129
- Locations
- 1
- Primary Endpoint
- Complete Blood Count (CBC), Urine Routine Examination, Diabetic Profile, Lipid Profile, Liver Profile, Kidney Profile
Study Overview
Brief Summary
Ayurveda, a traditional system of medicine, offers a holistic framework for disease diagnosis, treatment, and prevention. It emphasizes individual constitution (Prakriti) and pathological state (Vikriti), providing a personalized approach to healthcare. Prakriti-based assessments have been correlated with biochemical, genetic, and microbiome markers, demonstrating their potential for phenotyping individuals and predicting predisposition to metabolic disorders, including diabetes. Integrating Ayurvedic principles with modern biomedical approaches may enhance the early identification of at-risk individuals, improve personalized treatment strategies, and support a more comprehensive model for diabetes management and complication prevention.
This study aims to evaluate the effectiveness of a Whole-System Medicine approach incorporating Ayurvedic principles and modern diagnostics through the AIWeLL DM™ Protocol. By leveraging a personalized, multi-dimensional framework, this study seeks to improve diabetes management outcomes and explore potential avenues for disease reversal in select cases.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 25.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Type 2 diabetes patients, prediabetes
- •Duration of Diabetes should be less than 10 years.
Exclusion Criteria
- •Type 1 diabetes patients
- •Gestational diabetes
- •Smokers and alcoholics
- •T2DM patients under insulin
- •Pregnancy and Lactation
- •Diabetes patients with co-morbidities.
Outcomes
Primary Outcomes
Complete Blood Count (CBC), Urine Routine Examination, Diabetic Profile, Lipid Profile, Liver Profile, Kidney Profile
Time Frame: Before treatment, after treatment
Secondary Outcomes
- CGM indices, Gut microbiome composition (16sRNA metagenomic sequencing)(Before treatment, after treatment)