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Effect of Naturopathy and Yoga treatment to prevent kidney complications in Diabetes

Effect of Integrated Naturopathy and Yoga Intervention to prevent renal complications in Diabetes Mellitus - A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/068832
Enrollment
60
Registered
2024-06-12
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

Health Condition 1: E112- Type 2 diabetes mellitus with kidney complications

Interventions

Intervention1: Integrated module based on Naturopathy, Yoga and Nutritional interventions: NATUROPATHY PROTOCOL FOR TEN DAYS WITHIN HOSPITAL: Mud pack to eyes and abdomen,Steam bath with cold chest p

Sponsors

Dr Aditi Giridharan
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age range of 30-65 years 2. Long duration of Diabetes mellitus since diagnosis (T2DM since 8-10 years) 3. Patients with moderate to poor glycaemic control (defined as HbA1c greater than 8%) 4. Patients having diabetic dermopathy (diagnosed on clinical examination, defined as non-blanching, scaly, round or oval, red or purple macule or papules of size 1 to 2.5 cm , associated with hyperpigmentation, seen on front of leg). 5. Patients having eGFR either less than 60 mL/kg/1.73m2 (mildly decreased) OR eGFR more than or equal to 125mL/kg/1.73m2(elevated) 6. Diabetics with modifiable risk factors such as smoking, obesity, dyslipidaemia i.e., at risk of developing nephropathy 7. Diabetic patients who are also hypertensive

Exclusion criteria

Exclusion criteria: 1. Patients with overt proteinuria greater than 300mg/day 2. Patients having CKD Stage 3B-5, indicated as high risk for CKD progression or renal replacement therapy. 3. Presence of dyselectrolytemia 4. Patients with poorly healed diabetic wound 5. Newly diagnosed low risk DM patients with good glycemic control 6. Unstable medical or psychiatric conditions 7. Pregnant and lactating women (including those with Gestational Diabetes Mellitus)

Design outcomes

Primary

MeasureTime frame
1. Estimated GFR 2. Urinary Microalbumin / Urine Albumin-Creatinine RatioTimepoint: Baseline, 10th day post intervention, 3 months follow up post intervention

Secondary

MeasureTime frame
UK Prospective Diabetes Study (UKPDS) Cardiac Risk Engine Score Version 2 - includes Age, Duration of Diabetes, Glycosylated Haemoglobin, Lipid profile, Smoking history, ethnicity, presence/ absence of atrial fibrillationTimepoint: Baseline, 10th day post intervention, 3 months follow up post intervention

Countries

India

Contacts

Public ContactDr Sujatha K J

SDM College of Naturopathy and Yogic Sciences

draditigiridharan@gmail.com8971479004

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026