| CTRI Number |
CTRI/2022/01/039762 [Registered on: 27/01/2022] Trial Registered Prospectively |
| Last Modified On: |
19/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Agnisara Kriya in pre-diabetic population |
|
Scientific Title of Study
|
Effect of Agnisara Kriya on insulin resistance and Insulin sensitivity in pre-diabetic population |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Satish Pathak |
| Designation |
Assistant Director of Research |
| Affiliation |
Kaivalyadham SMYM Samiti |
| Address |
Room. No. 1, Ground floor, Scientific Research Department, Swami Kuvalayananda Marg Near Valvan Dam Lonavala
Pune
MAHARASHTRA
410403
India |
| Phone |
9869024938 |
| Fax |
|
| Email |
sdpathak7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Pratibha Rajbhoj |
| Designation |
Research Officer |
| Affiliation |
Kaivalyadham SMYM Samiti |
| Address |
Room. No. 3, Ground floor, Scientific Research Department, Swami Kuvalayananda Marg Near Valvan Dam Lonavala
Pune
MAHARASHTRA
410403
India |
| Phone |
9881937754 |
| Fax |
|
| Email |
pratibha@kdham.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Pratibha Rajbhoj |
| Designation |
Research Officer |
| Affiliation |
Kaivalyadham SMYM Samiti |
| Address |
Room. No. 3, Ground floor, Scientific Research Department, Swami Kuvalayananda Marg Near Valvan Dam Lonavala
Pune
MAHARASHTRA
410403
India |
| Phone |
9881937754 |
| Fax |
|
| Email |
pratibha@kdham.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Yoga and Naturopathy
61-65, Institutional Area, Janakpuri, New Delhi - 110058 |
| Kaivalyadhama SMYM Samiti
Swami Kuvalayananda Marg, Valvan, Lonavla- 410403 |
|
|
Primary Sponsor
|
| Name |
Kaivalyadham SMYM Samiti |
| Address |
Swami Kuvalayananda Marg Near Valvan Dam Lonavala |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Central Council for Research in Yoga and Naturopathy |
61-65 Janakpuri Institutional Area Janakpuri
New Delhi Delhi 110058 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shivam das |
Lonavala Industrial Cooperative Estate Ltd |
Room No 2, First floor, Admin Department, Administrative Building
Nangargaon, Lonavla
Pune
MAHARASHTRA |
9923961819
shivamdas190@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee For Kaivalyadhadham Yoga Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pre-diabetic male and female participants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Agnisara Kriya |
Agnisara Kriya practice constituting 5 rounds each of 20 movements for three months, five days a week, once a day |
| Comparator Agent |
Wait-listed control group |
No intervention- they will not be engaged in any activity. They will be asked to continue with their routine activity |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Pre-diabetic individuals without any other health issues
Participants who are willing to sign the written consent.
|
|
| ExclusionCriteria |
| Details |
Cardio Vascular diseases (CVD), Asthma, Hernia
Undergone any kind of abdominal surgery
Hypertension
Individuals practising yoga
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the effect of Agnisara Kriya on insulin resistance in pre-diabetic population
To assess the effect of Agnisara Kriya on insulin sensitivity in pre- diabetic population |
at baseline, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the effect of Agnisara Kriya on liver function test, lipid profile, body mass index, body weight and abdominal girth.
To study the detraining effect of the Agnisara Kriya on insulin resistance and insulin sensitivity in pre-diabetic population |
at baseline, 3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
03/02/2022 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is being postulated that in near future India may become the capital of diabetes. It is feared that there may be an inordinate increase in metabolic disorders and NCD all over the world. The Agnisara Kriya practise is known to improve the digestive fire of the practitioner hence it may have a role in improving the metabolism. It is observed through scientific studies too, that Agnisara Kriya, in combination with other Yoga practices, is helpful in controlling diabetes. Therefore, it might have a role in dealing with insulin resistance and insulin sensitivity. On this account, this Kriya needs to be studied extensively with sensitive parameters. Hence the present proposal aims to examine the effect of Agnisara Kriya practice on insulin resistance and insulin sensitivity in the pre-diabetic population. |