| CTRI Number |
CTRI/2024/06/068832 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Naturopathy and Yoga treatment to prevent kidney complications in Diabetes |
|
Scientific Title of Study
|
Effect of Integrated Naturopathy and Yoga Intervention to prevent renal complications in Diabetes Mellitus - A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aditi Giridharan |
| Designation |
PG Student |
| Affiliation |
SDM College of Naturopathy and Yogic Sciences |
| Address |
Department of Natural Therapeutics,
SDM College of Naturopathy and Yogic Sciences, Ujire, Belthangady Taluk, Dakshina Kannada 574240
Karnataka, India
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
8971479004 |
| Fax |
|
| Email |
draditigiridharan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aditi Giridharan |
| Designation |
PG Student |
| Affiliation |
SDM College of Naturopathy and Yogic Sciences |
| Address |
Department of Natural Therapeutics,
SDM College of Naturopathy and Yogic Sciences, Ujire, Belthangady Taluk, Dakshina Kannada 574240
Karnataka, India
KARNATAKA
574240
India |
| Phone |
8971479004 |
| Fax |
|
| Email |
draditigiridharan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujatha K J |
| Designation |
Vice Principal and Dean Division of Natural Therapeutics Department |
| Affiliation |
SDM College of Naturopathy and Yogic Sciences |
| Address |
Department of Natural Therapeutics,
SDM College of Naturopathy and Yogic Sciences, Ujire, Belthangady Taluk, Dakshina Kannada 574240
Karnataka, India
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9480401646 |
| Fax |
|
| Email |
drsujathadinesh2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara Yoga and Nature Cure Hospital,Shantivana,Dharmasthala,Belthangady,Dakshina Kannada-574216
Karnataka
India |
|
|
Primary Sponsor
|
| Name |
Dr Aditi Giridharan |
| Address |
Department of Natural Therapeutics, SDM College Of Naturopathy and Yogic Sciences, Ujire, Belthangady, Dakshina Kannada, Karnataka, India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aditi Giridharan |
Shri Dharmasthala Manjunatheshwara Yoga and Nature cure Hospital Shanthivana |
COE Department of Natural Therapeutics, Sri Dharmasthala Manjunatheshwara Yoga and Nature Cure Hospital, Shanthivana, Belthangady, Dakshina Kannada 574216, Karnataka, India
Dakshina Kannada
KARNATAKA |
8971479004
draditigiridharan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E112||Type 2 diabetes mellitus with kidney complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 pack, enema with full body massage, Cold hip bath, Cold abdomen pack, neutral immersion bath, Gastrohepatic pack, Warm salt foot bath, Kidney Pack, Partial body massages, full mud bath, neutral arm and foot bath for 10 days
(Note: Each modality will be repeated twice over a period of the participants 10 day stay in the Naturopathy hospital
YOGA PROTOCOL( WITHIN HOSPITAL) - YOGA DP Module ( Yoga for Diabetes Prevention module) daily for a period of TEN DAYS. This module includes ShithilikaranaVyayama for 5 minutes, Surya Namaskar for 15 minutes, Asanas for 25 minutes, Pranayama for 13 minutes and relaxation (Yoga Nidra) for 12 minutes, total duration - 70 minutes for TEN DAYS
DIET PROTOCOL (WITHIN HOSPITAL) - Natural vegetable and juice based diet including Raw juices, boiled diet, Fruit juices, sprouts, cucumber, for 10 days
Integrated out patient follow up module - It is aimed at the 5 pillars of diabetic nephropathy management, additionally stress reduction has been included:-
1. Glycemic control - Cold Compress ( thrice weekly for three months), Natural Diet rich in vegetables like Pumpkin, sweet potato, Bittergourd,Lady’s finger, Onion, Methi
buttermilk/methi water for the designated period of THREE MONTHS, atleast 5 times per week
2. Risk Factor reduction (for Smoking, Obesity or Dyslipidemia IF PRESENT) - Apple and walnut consumption daily, Neutral hip bath weekly twice, Sudarshan Kriya Yoga based breathing weekly thrice, Cold abdomen packs on alternate days FOR THREE MONTHS
3. Blood Pressure Control and Stress Reduction - Aromatherapy with Lavender oil for ten minutes daily at night for a period of THREE MONTHS, MSRT Technique (Mind Sound Resonance Technique) on alternate days for THREE MONTHS
4. Nephroprotection - Diet protocol based on kidney protective foods like Red grape, Saffron, Strawberry,
Hibiscus tea, Carrot,
Turnip, Green tea, Fennel
tea, Turnip, Ginger-
honey water, Noni
fruit juice, Fermented
oats, Kidney pack
5. Renin Angiotension blockade - Soyabean and Tomato juice (natural renin angiotensin blockers) weekly twice for THREE MONTHS
6. Cardiovascular protection - Yoga based Cardiac rehabilitation (Yoga CaRe module) for a period of THREE MONTHS, weekly twice, Cold Abdomen Pack (as mentioned above), Meditarranean diet with Intermittent fasting or Calorie Restriction for THREE MONTHS
|
| Comparator Agent |
Standard of Care
According to the KDIGO 2022 Guidelines for Diabetic Kidney Disease, the treatment is aimed at the following pillars: Lifestyle and self management, glycemic control ,blood pressure control, cardiovascular risk reduction using SGLT2 Inhibitors, MRAs, anti platelet drugs , lipid management and additional drugs for Cardiovascular and renal protection |
Oral anti-diabetic agents, SGLT 2 Inhibitors, and other conventional medical management for diabetes mellitus as per primary physician/ diabetologist with NO additional intervention through Naturopathy and Yoga |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Estimated GFR
2. Urinary Microalbumin / Urine Albumin-Creatinine Ratio |
Baseline, 10th day post intervention, 3 months follow up post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 fibrillation |
Baseline, 10th day post intervention, 3 months follow up post intervention |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="82" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| Date of Study Completion (India) |
15/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
EEven though renal function decline is considered relentless in chronic kidney disease (CKD), improvement has been shown in patients with hypertensive nephropathy, but improvers were not prevalent in diabetic nephropathy. This gives us a solid reason to form an evidence based Naturopathy and Yoga protocol specifically for prevention of diabetic kidney disease using appropriate screening and early markers to identify these patients and treat them prophylactically. a Grouping – After screening, subjects will be randomized into intervention and control group using computer generated randomization sheet Group 1: n = 30 Group 2: n = 30 Group 1: 10 days of in-patient intervention followed by 3 months of tele-intervention, monitoring and follow up Group 2: Under conventional management
|