Impact of Ayurveda based personalized diet plans on Diabetes Mellitus

Phase 3

Not yet recruiting

• Conditions: Type 2 diabetes mellitus. Ayurveda Condition: PRAMEHAH,

• Registration Number: CTRI/2025/04/085314
• Lead Sponsor: Dr. Sushma Kumari

Brief Summary

Primary objective of this study is Evaluation of the Impact of defined Ayurvedic menu plans along with Ayurveda based intensive personal nutritional programme on Diabetes Mellitus type 2.

**Secondary objectives:**

1. Identification of variables (e.g. problems, conflicts, possibilities for motivation) influencing nutritional behavior of study participants and reasons for failing to comply.

2. Derivation of tailor-made, practicable recommendations for the target group.

3. To observe the duration of the effect and/or any adverse effect and/or late effect of the intervention during follow up.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-07
• Last Update Posted: 2025-11-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

• 2.For Prediabetic condition: A fasting plasma glucose level of 100 to 125 mg/dL (5.55-6.94 mmol/L), 2-hour postload glucose level of 140 to 199 mg/dL (7.77-11.04 mmol/L), HbA1c level of 5.7% to 6.4%, 3.Diagnosed DM Type 2: A fasting plasma glucose level of 126 mg/dL (6.99 mmol/L) or greater upto 200mg/dL (11.1mmol/L), a 2-hour postload glucose level of 200 mg/dL (11.1 mmol/L) or greater up to 280 mg/dL (15.5mmol/L), HbA1c level of 6.5% or 11%.
• will be included.
• 4.Any one of these is high.

Exclusion Criteria

• 1.DM Type 1, DM Type 2 on insulin, Diabetes induced due to endocrinopathies like acromegaly, Cushing syndrome etc.
• 2.Other diseases like Renal dysfunction, Liver disease, Unmanaged thyroid disease, 3.Chronic alcoholism, 4.Acute or chronic inflammatory diseases.
• 5.Pregnant, breast feeding women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in FBS by using Ayurveda diet menu plans along with Ayurveda based intensive personal nutritional counselling program.	The Baseline, 30th Day, 90th day of intervention period and after 30 days post intervention follow up period.

Secondary Outcome Measures

Name	Time	Method
1.Reduction in biochemical biomarkers i.e., HbA1C and PPBS.	2.Reduction in other Diabetes Risk factor i.e., S. Insulin, HOMA IR, S. Triglycerides, Tr.G. index.

Trial Locations

Locations (1)

All India Institute of Ayurveda, New Delhi; 🇮🇳 Delhi, DELHI, India

All India Institute of Ayurveda, New Delhi

🇮🇳Delhi, DELHI, India

Dr Sushma Kumari

Principal investigator

07807254276

sushma0767@gmail.com