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CTRI Number  CTRI/2023/07/055727 [Registered on: 26/07/2023] Trial Registered Prospectively
Last Modified On: 07/07/2023
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   Immediate effect of yogic postures on gastric motility among diabetes mellitus 
Scientific Title of Study   Immediate effect of specific yogic postures on gastric motility in diabetes mellitus patients -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 Kadagouda Patil 
Designation  PG Scholar 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire 
Address  Department of Yoga Therapeutics, Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire Belthangady

Dakshina Kannada
KARNATAKA
574240
India 
Phone  9901447661  
Fax    
Email  kadagoudapatil34@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kadagouda Patil 
Designation  PG Scholar 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire 
Address  Department of Yoga Therapeutics, Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire Belthangady


KARNATAKA
574240
India 
Phone  9901447661  
Fax    
Email  kadagoudapatil34@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shivaprasad Shetty 
Designation  Dean division of Yoga Therapeutics 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire 
Address  Department of Yoga Therapeutics, Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire Belthangady

Dakshina Kannada
KARNATAKA
574240
India 
Phone  9731854585  
Fax    
Email  drshivapshetty70@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara Yoga and Naturecure hospital Shanthivana 
 
Primary Sponsor  
Name  Dr Kadagouda Patil 
Address  Department of Yoga Therapeutics, Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire Belthangady 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kadagouda Patil  Sri Dharmasthala Manjunatheshwara Yoga and Naturecure hospital Shanthivana  Department of Yoga Therapeutics, Shanthivana, Dharmasthala
Dakshina Kannada
KARNATAKA 
09901447661

kadagoudapatil34@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Dharmasthala Manjunatheshawara College of Naturopathy and Yogic sciences Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Asana practices  Standing asana: padahstasana (Hand to foot pose): Stand with the spine erect, feet together and hands beside the body. Relax the body. This is the starting position.Slowly bend forward, first bending the head, taking the chin towards the chest, then bending the upper trunk, relaxing the shoulders forward and letting the arms go limp. Bend the mid-trunk and finally the lower trunk. While bending forward,Place the fingers underneath the toes or bring the palms to the floor beside the feet. If this is not possible, bring the fingertips as near to the floor as possible. Relax the back of the neck and try to bring the forehead to the knees. In the final position the body is bent forward with the knees straight and the forehead touching the knees. Hold the position, Slowly return to the starting position in the reverse order. Duration: 5 minutes Supine asana: Pawanmuktasana (wind release pose): Lie down on the back, legs straight and hands by the side of the body. Exhale and while inhaling slowly raise the legs to a 90 degree angle from the floor. Bend both legs at the knees and rest the thighs against the abdomen, keeping the knees and ankles together. Encircle the knees with both arms, hands clasping opposite elbows. Bend the neck and place the chin on the knees. Duration: 5 minutes Prone asana: Bhujangasana (cobra pose): Keep the hands and feet in place. Slide the chest forward and raise first the head, the shoulders, then, straightening the elbows, arch the back into the cobra pose. This will lower the buttocks and hips to the floor. Bend the head back and direct the gaze upward to the eyebrow centre. The thighs and hips remain on the floor and the arms support the trunk. Unless the spine is very flexible the arms will remain slightly bent. Duration: 5 minutes Sitting asana: Vakrasana (Twisted pose): Start in a sitting position with legs stretched out and hands resting on the ground by the side. Slightly bend your left leg while keeping the sole of your feet resting on the ground. Keep your right leg straight on the ground. Twist your torso towards the left and bring in your right hand over the left leg. The right hand should be placed over the left toe or you can hold the left ankle with your right hand. Position the left hand behind to support the body. The neck is in a twisted position, in line with the torso. Keep a normal breath in this position now, release the pose by slowing releasing the hands. Twist towards your right Bring the hands to the side of the body, resting on the ground. Lower the left leg and let it rest on the ground. Repeat the same steps on the right side as well. Duration: 5 minutes Total duration:-20 minutes 
Comparator Agent  Supine rest  The subjects in control group will be asked to practice supine rest in corpse pose along with breath awareness for the same duration of 20 minutes.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects with type 2 diabetes mellitus meeting the American Diabetic Association diagnostic criteria and those who are on oral anti diabetic therapy 
 
ExclusionCriteria 
Details  1) Patients suffering with co-morbidity.
2) History of lactose intolerance, stroke, spinal cord injury.
3) Analgesics, opioid use in last week.
4) Insulin dependent.
5) Women during Menstruation.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Electrogastrogram (EGG)
Random blood sugar (RBS) 
Baseline and immediately after the intervention 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   07/08/2023 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Yoga, the Indian system of medicine, lay emphasis on asanas as an essential component of therapy based on its disease model. All asanas with breathing seems to offer deep stimulation by activating the basic autonomic reflexes specially acting on the enteric division of autonomic nervous system by the intra abdominal pressure changes. It also enhances a mechanical effect of laxation. According to the Indian system of health, the apanavata in the gastrointestinal tract influences other vatas in the body leading to various disorders.(18) Though widely practiced the impact of asanas is yet to be established.

Hence this is the study to see the effect of yoga asanas on gastrointestinal motility with the hypothesis that, after the practice of asanas there will be an increase in gastrointestinal motility in diabetes mellitus.

a.     Grouping: Two groups-

Group 1- case group (n)=34 (Specific yogic postures)

 Group 2-control group (n)=34 ( supine rest with breathing awareness)

a.     Method:

1)       Subjects satisfying the selection criteria and who have agreed to give consent for participation in the study are assessed at baseline.

2)     Then subjects were randomized into two groups [group 1 and group 2].

3)       Pre EGG will be taken for both groups.

4)       Series of asanas will be performed by group 1 under the guidance of a yoga and naturopathy physician.

5)       Post EGG will be taken immediately after the intervention for both groups.  

6)    The whole data acquisition will be done in a supine position.

 
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