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
|
|
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
|
|
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. |