CTRI Number |
CTRI/2021/12/039068 [Registered on: 30/12/2021] Trial Registered Prospectively |
Last Modified On: |
22/12/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Yoga & Naturopathy |
Study Design |
Other |
Public Title of Study
|
yoga for diabetic autonomic neuropathy |
Scientific Title of Study
|
Comparative assessment of yoga-based intervention vs. American Diabetes Association exercise regime along with standard of care for autonomic Neuropathy in diabetes mellitus: An Exploratory clinical trial |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Puneet Dhamija |
Designation |
Additional Professor |
Affiliation |
Aiims Rishikesh |
Address |
level 4 Department of Pharmacology
Dehradun UTTARANCHAL 249203 India |
Phone |
8475000292 |
Fax |
|
Email |
drpdhamija@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Puneet Dhamija |
Designation |
Additional Professor |
Affiliation |
Aiims Rishikesh |
Address |
level 4 Department of Pharmacology
Dehradun UTTARANCHAL 249203 India |
Phone |
8475000292 |
Fax |
|
Email |
drpdhamija@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Puneet Dhamija |
Designation |
Additional Professor |
Affiliation |
Aiims Rishikesh |
Address |
level 4 Department of Pharmacology
Dehradun UTTARANCHAL 249203 India |
Phone |
8475000292 |
Fax |
|
Email |
drpdhamija@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Aiims Rishikesh |
Address |
Virbhadra Road Shivaji Nagar, near Barrage, Sturida Colony, Rishikesh, Uttarakhand 249203 |
Type of Sponsor |
Research institution and hospital |
|
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 |
Ramesh kumar |
aiims |
Room No 025402, Level 4,pharmacology AIIMS Rishikesh
Dehradun UTTARANCHAL |
9027300507
rks.aiimsrishikesh@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
institutional ethical committee , Aiims Rishikesh |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: E134||Other specified diabetes mellituswith neurological complications, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
exercise |
Warm up
Aerobic Training
Cooling Down
|
Intervention |
yoga |
1 Starting prayer: Asatoma Sat Gamaya 3 min
2 Asana
Preparatory Sukshma Vyayamas and Shithilikarana Practices
Tadasana
Tiryak Tadasana
Katichakrasana
Bhujangasana
Pashchimottanasana
Malasana
Mandukasana
Ardhaustrasana
Ardhmatsyendrasana
Gomukhasana
Makarasana
30 min.
3 Pranayama
Anulom
Anulom-Vilom
Naadi-shodhan
Ujjayi
Bharamari
10 min
4. Kriya and Mudra-Bandh
Kapalbhati
Agnisara
Ashwini Mudra,
Moolbandha
10 min
5. Meditation
Savita dhyan [Meditation (for stress management for deep relaxation and silencing the mind)]
5 min
6. Resolve (I am completely healthy) 1 min
7. Closing prayer: Sarvebhavantu Sukhinah 1 min
8. Naadyoga
Hansh Dhvani of Pt. Ravishankar (During over the practice as background sound)
Total 60 min
|
|
Inclusion Criteria
|
Age From |
35.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Patients of Type two diabetes mellitus with diagnosed Autonomic Neuropathy.
Age Between 35 - 60 years.
|
|
ExclusionCriteria |
Details |
 Patients opting for treatment not in compliance with randomization sequence
 Patients on insulin
 Patients with HbA1c > 11%.
 Patients with acute macro vascular complications, cancer, pulmonary tuberculosis, and rheumatoid arthritis
 Patients who will be unable to perform yoga.
 Patients receiving drugs like drotaverine, beta-blockers or any other drug likely to affect autonomic function tests
 Patients with history of angina/uncontrolled hyperglycaemia/any other contraindication applied by American Diabetic Association (ADA).
|
|
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 |
effect of Yoga based intervention on Autonomic function in Type Two Diabetes Mellitus patients suffering from Autonomic Neuropathy |
baseline , 4 week, 8th week and 12th week
|
|
Secondary Outcome
|
Outcome |
TimePoints |
Change in HbA1c, lipid profile, Nerve Conduction Velocity, Liver function test, Kidney function test, fasting blood sugar, Post prandial blood sugar, Random blood Sugar
Change in HbA1c, lipid profile, Nerve Conduction Velocity, Liver function test, Kidney function test, fasting blood sugar, Post prandial blood sugar, Random blood Sugar
|
4th week, 8th week and 12th week |
Change in dose of Oral hypoglycaemic agents |
4th week, 8th week and 12 week |
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
05/01/2022 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="2" Months="1" Days="1" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
no |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Yoga may also reduce activation of the sympathoadrenal system and hypothalamic-pituitary-adrenal axis, and may enhance parasympathetic activity, thereby alleviating stress. Clinical trials with both healthy and ill participants have shown the benefit of yoga on stress reduction. By supporting stress resilience, yoga may prevent stress-induced rises in cortisol, thus controlling the rise in blood glucose levels. Pilot studies conducted mainly in India have shown decreased stress levels among diabetics after a yoga intervention. Evidence also suggests that stress leads to poor food choices, including increased consumption of foods high in fat, sugar, and salt. By reducing stress and improving mindfulness, yoga practice may lead to improved self-care behaviors including improved diet and physical activity. Randomized trials with adults at risk for cardiovascular disease and binge eaters have shown improved dietary outcomes after a yoga intervention. Thus, yoga may positively impact stress, diet, and other self-care tasks that contribute to improved glycaemic control. Aim: To compare the efficacy of yoga-based intervention vs. American Diabetes association exercise regime in addition with standard of care for autonomic neuropathy in type two diabetes mellitus Hypothesis Yogic exercises are equally effective as compared to the American Diabetes association exercise regime for improving autonomic functions in patients suffering from diabetic autonomic neuropathy |