Efficacy of Ayurveda therapies on Diabetes biomarkers

Evaluating the efficacy of Diabetic specific diet and lifestyle modifications in comparison with Ayurvedic Shodhana-Rasayana in the management of Madhumeha (Diabetes Mellitus type2) – A randomized comparative clinical trial - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/057404

Enrollment

138

Registered

2023-09-11

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Patients diagnosed with Diabetes Mellitus according to WHO criteria Subjects diagnosed for Madhemha based on general diagnostic criteria according to document of Protocol for Prevention and Control of Diabetes through Ayurveda, MoA, Page no 372016 Recently diagnosed patients who are not on OHA both overweight and obese and normal BMI ICMR criteria Subjects of either gender aged more than 18 years. Fasting blood sugar more than 126 mgperdl to 250 mgperdl Patients with random blood sugar level more than 200 mgperdl to 450 mgperdl Postprandial blood sugar more than 200 mgperdl to 450 mgperdl Glycosylated Haemoglobin more than 6.5 to 15

Exclusion criteria

Exclusion criteria: Emergency cases of diabetes or under immediate consideration for hospitalization and Type 1 DM or Insulin-dependent. Patient with inflammatory bowel disease chronic diarrhoea or malabsorption; Hepatitis etc. Patient with a history of other complications with DM. Female patient who is pregnant, or breast-feeding or is considering becoming pregnant during the study or for 6 months after the last dose of study medication; Patients reporting to be hypersensitive to any of the proposed trial drug. Currently under any other trial.

Design outcomes

Primary

Measure	Time frame
Blood sugar fasting & post prandial & HbA1C. (in mg/dl) Sr. Insulin, LDL-cholesterol & triglycerides Biomarkers such as, Apolipoprotein A1, Adiponectin hs-CRP Body weight & Hip-waist circumferenceTimepoint: Baseline, day 30, Day 60, Day 90 and Day 120	—

Secondary

Measure	Time frame
Quality of Life in DM by QOLID Ayurveda parameters such as Roga & Rogi Bala Timepoint: Quality of life assessment specific to Diabetes Mellitus will be assessed at the beginning day 0 & end of therapy day 90 Roga and Rogi bala will be assessed at the beginning day 0 and end of therapy day 90	—

Countries

India

Contacts

Public ContactRaja Ram Mahto

All India Institute of Ayurveda

mahtorajaram@yahoo.com8877033663

Outcome results