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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  
Aiims Rishikesh 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 

 

 
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