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临床试验/CTRI/2026/01/100074
CTRI/2026/01/100074尚未招募不适用

Development and Validation of Medovaha Srotodushti Nidana Questionnaire and Analytical Cross-Sectional Study to Compare Degree and Pattern of Medovaha Srotodushti in Type 2 Diabetes Mellitus Patients With and Without Non-Alcoholic Fatty Liver Disease (NAFLD)

National Institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2026年9月14日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
140
试验地点
1

研究概览

简要总结

This dissertation is a two-phase methodological and analytical cross-sectional study designed to integrate Ayurvedic pathophysiology with modern metabolic assessment in Type 2 Diabetes Mellitus (T2DM). In Phase 1, a standardized Medovaha Srotodushti Nidana Questionnaire is systematically developed and validated through extensive review of classical Ayurvedic texts, expert consultations, pilot testing, and statistical evaluation of reliability and validity (including internal consistency, test–retest reliability, and content and construct validity). The tool operationalizes classical Nidana such as Avyayama (physical inactivity), Divaswapna (day sleep), Medyanam Atibhakshana (excessive intake of fatty foods) and related lifestyle-behavioral factors into measurable domains. In Phase 2, the validated questionnaire is applied in an analytical cross-sectional study involving 140 T2DM patients, equally divided into those with and without Non-Alcoholic Fatty Liver Disease (NAFLD), to compare the degree and pattern of Medovaha Srotodushti. The study further evaluates correlations between questionnaire scores and biomedical parameters including BMI, lipid profile, liver enzymes (SGOT/SGPT), fasting blood glucose, and HbA1c. By generating comparative and correlative evidence, this research aims to bridge a critical gap in Ayurvedic research by providing a scientifically validated assessment tool and enhancing understanding of Medovaha Srotodushti in the context of diabetes and NAFLD, thereby supporting integrative diagnosis, risk stratification, and preventive strategies.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Group1 Patients of either sex aged between 18 to 70 years, Patients diagnosed as Prameha (Type 2 Diabetes Mellitus) with fasting plasma glucose level 126 mg per dl or higher and or HbA1C level more than 6.4 percentage, Individuals with non-alcoholic fatty liver disease Group 2 Patients of either sex aged between 18 to 70 years, Patients diagnosed as Prameha (Type 2 Diabetes Mellitus) with fasting plasma glucose level 126 mg per dl or higher and or HbA1C more than 6.4 percentage.

排除标准

  • group 2 Patients diagnosed with Type 1 Diabetes Mellitus (IDDM) Patients with malignancies or any other serious illness.
  • Pregnant and lactating women.
  • Alcohol consumption more than 20 g per day (women) and more than 30 g per day (men).
  • Patients with alcoholic fatty liver disease Group 2 Patients diagnosed with Type 1 Diabetes Mellitus (IDDM).
  • Patients with malignancies or any other serious illness.
  • Patients diagnosed with diabetes insipidus Patients with alcoholic and non alcoholic fatty liver disease.

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Ganpat Kumar

National Institute of Ayurveda, Jaipur

研究点 (1)

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