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临床试验/CTRI/2025/04/084421
CTRI/2025/04/084421尚未招募不适用

To Evaluate the Effectiveness of a Whole-System Medicine Approach-Based AIWeLL DM™ Protocol on Diabetes: A Single-Arm Pre-Post Study

AYUR.AI PRIVATE LIMITED1 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2025年4月22日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
129
试验地点
1
主要终点
Complete Blood Count (CBC), Urine Routine Examination, Diabetic Profile, Lipid Profile, Liver Profile, Kidney Profile

研究概览

简要总结

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.

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 60.00 Year(s)(—)
性别
All

入选标准

  • Type 2 diabetes patients, prediabetes
  • Duration of Diabetes should be less than 10 years.

排除标准

  • Type 1 diabetes patients
  • Gestational diabetes
  • Smokers and alcoholics
  • T2DM patients under insulin
  • Pregnancy and Lactation
  • Diabetes patients with co-morbidities.

结局指标

主要结局

Complete Blood Count (CBC), Urine Routine Examination, Diabetic Profile, Lipid Profile, Liver Profile, Kidney Profile

时间窗: Before treatment, after treatment

次要结局

  • CGM indices, Gut microbiome composition (16sRNA metagenomic sequencing)(Before treatment, after treatment)

研究者

发起方
AYUR.AI PRIVATE LIMITED
申办方类型
Other [Private company ]

研究点 (1)

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