| CTRI Number |
CTRI/2023/08/056782 [Registered on: 22/08/2023] Trial Registered Prospectively |
| Last Modified On: |
22/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Other (Specify) [Transcranial Magnetic Stimulation (TMS)] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of Yoga and non-invasive brain stimulation on mental function, stress and aging in obesity: A Randomized control Trial |
|
Scientific Title of Study
|
Evaluation of the efficacy of Yoga-Based Intervention and Transcranial
Magnetic Stimulation on cognition, stress and aging in Obesity: 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 Raj Kumar Yadav |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room No. 2004, 2nd Floor, Department of Physiology, Teaching block, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9811319057 |
| Fax |
|
| Email |
raj3kr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raj Kumar Yadav |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room No. 2004, 2nd Floor, Department of Physiology, Teaching block, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9811319057 |
| Fax |
|
| Email |
raj3kr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr. DEBANJAN GHOSH |
| Designation |
PhD STUDENT |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room No. 6014, 6th Floor, Department of Physiology, Convergence Block, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
7094051053 |
| Fax |
|
| Email |
debanjanghosh24@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES (AIIMS), NEW DELHI, SRI AUROBINDO MARG, ANSARI NAGAR, ANSARI NAGAR EAST, NEW DELHI, DELHI-110029 |
| Department of Science and technology (DST) |
|
|
Primary Sponsor
|
| Name |
Department of Science and Technology |
| Address |
Technology Bhavan, New Mehrauli Road,
New Delhi-110 016 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Prof Raj Kumar Yadav |
All India Institute of Medical Sciences, New Delhi |
Room No.- 6014, 6th Floor, Department of Physiology, Convergence Block, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029
New Delhi
DELHI |
9811319057
raj3kr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E660||Obesity due to excess calories, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Transcranial Magnetic Stimulation [Real intermittent theta burst stimulation (real iTBS)] group |
Baseline assessment consisting of Corticomotor excitabiliy (CME) parameters i.e. Resting Motor Threshold (RMT) and Motor Evoked Potential (MEP) of the subject will be assessed on the using single pulse of TMS after determination of the motor hotspot of the target muscle i.e. thenar muscle of the right hand.
After following baseline assessments the participants in Real iTBS group will be given magnetic stimulation of minimum 15 sessions or maximum 20 sessions for 1 month by using Trancranial magnetic stimulation coil for 3 min 9 sec on the left dorsolateral prefrontal cortex. RMT and MEP will be measured on the next day after completion of all intervention.The final follow-up assessment comprising of CME parameters i.e. RMT and MEP assessment would be done on both the groups at 1 month after completion of intervention.
|
| Comparator Agent |
Transcranial Magnetic Stimulation [Sham intermittent theta burst stimulation (sham iTBS)] group |
Baseline assessment consisting of Corticomotor excitabiliy (CME) parameters
i.e. Resting Motor Threshold (RMT) and Motor Evoked Potential (MEP) of the
subject will be assessed on the using single pulse of TMS after determination
of the motor hotspot of the target muscle i.e. thenar muscle of the right hand. After following baseline assessments the participants in sham iTBS group will be given magnetic stimulation as placebo of
minimum 15 sessions or maximum 20 sessions for 1 month by using
Trancranial magnetic stimulation coil for 3 min 9 sec. RMT and MEP will be measured on the next day after
completion of all intervention. The final follow-up
assessment comprising of CME parameters i.e. RMT and MEP assessment
would be done at 1 month after completion of intervention. |
| Comparator Agent |
Yoga Group (Wait listed Control group)
|
The participants in this group will include:
â— Diet as per ICMR guidelines
â— Standard treatment protocol (i.e.obesity medications, if any, prescribed by doctors will continue).
â— Receive yoga as an intervention after duration of study gets over.
|
| Intervention |
Yoga group (Yoga-based lifestyle intervention group) |
Yoga-based lifestyle intervention (YBLI) group- pre-tested YBLI for 1 month along with dietary guidelines. This intervention program will be an outpatient-based, for 5 days/ week for approx 1 hour in morning, for 1 month as an active, short term intervention under direct supervision of yoga therapist & medical experts/investigators at IHC, Dept of Physiology, AIIMS, New Delhi.
It will be an integrated intervention, consisting of theory and practice sessions
of Patanjali yoga. This intervention has shown efficacy in different patient
populations (including obesity) as well as healthy individuals. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Body Mass Index (BMI) > 25 kg/m2 & < 35 kg/m2
2. The participants must be able to participate and comply with the
intervention, and preferably from National Capital Region (NCR).
3. Right handed participants
4. Should be able to read and comprehend the administered questionnaires. |
|
| ExclusionCriteria |
| Details |
1. Already in weight reduction programme including yoga in the last 6
months.
2. Uncontrolled diabetes mellitus
3. Uncontrolled hypertension
4. Patients with a disease of the thyroid gland and other chronic
illnesses/autoimmune diseases/psychiatric disease.
5. Patients with severe physical ailments like myocardial infarction, fracture
6. Patients with metal implants. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the effects of yoga-based intervention & transcranial
magnetic stimulation in participants with obesity on the following:
a) Cognition
b) Oxidative stress
c) Cellular aging |
There will be 3 time points- at baseline, after 1 month & after 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the effects of yoga-based intervention & transcranial
magnetic stimulation in participants with obesity on the following:
a) Expression profile of miRNA related to oxidative stress and
neuroplasticity
b) circadian rhythm (melatonin) & its gene expression |
There will be 3 time points- at baseline, after 1 month & after 2 months |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
01/09/2023 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
- |