| CTRI Number |
CTRI/2025/07/090540 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| 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
|
Understanding the mechanism of how complementary yoga therapy is helping in Depression |
|
Scientific Title of Study
|
Neurophysiological basis of yoga as an adjunct therapy in Major Depressive Disorder |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kaviraja Udupa |
| Designation |
Professor |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
Department of Neurophysiology
NIMHANS
Bangalore
KARNATAKA
560029
India |
| Phone |
8026995914 |
| Fax |
|
| Email |
kaviudupa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Balakrishnan K |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
Department of Neurophysiology
NIMHANS
Bangalore
KARNATAKA
560029
India |
| Phone |
7373997077 |
| Fax |
|
| Email |
krish.balakannan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Balakrishnan K |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
Department of Neurophysiology
NIMHANS
KARNATAKA
560029
India |
| Phone |
7373997077 |
| Fax |
|
| Email |
krish.balakannan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Science and Technology SATYAM (Science and Technology for Yoga and Meditation) |
|
|
Primary Sponsor
|
| Name |
DST SATYAM (Science and Technology for Yoga and Meditation) |
| Address |
Department of Science and Technology 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 |
| Dr Kaviraja Udupa |
National Institute of Mental Health and Neurosciences |
Room No: 1010, Special OPD Block, CNN Laboratory, Department of Neurophysiology, NIMHANS Bengaluru India 560029
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
08026995614
kaviudupa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee NIMHANS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F330||Major depressive disorder, recurrent, mild, (2) ICD-10 Condition: F331||Major depressive disorder, recurrent, moderate, (3) ICD-10 Condition: F320||Major depressive disorder, singleepisode, mild, (4) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control Group |
Group will receive treatment as usual, pharmacotherapy and/or psychotherapy. |
| Intervention |
Yoga Therapy |
8 weeks of yoga therapy. YOGA THERAPY MODULE FOR DEPRESSION (ONE HOUR DURATION). The below mentioned yoga practices are not meant for self-learning. These yoga practices are to be performed under the guidance of a trained yoga therapist only. I. PREPARATORY PRACTICES a) Sukshma & Sthulavyayama (Loosening practices) 05 min b) Suryanamaskar (Sun salutation): (3 Rounds) 10 min c) Shavasana - 1- Relaxation 1-2 min II. ASANAS AND MUDRAS Standing series of asanas 2 min a) Ardhachakrasana Sitting series of asanas 4 min (2 min each) a) Ushtrasana b) Paschimatanasana Prone series of asanas 2 minutes a) Bhujangasana b) Shavasana -2 - Yogic abdominal breathing 2 min Supine series of asanas 6 min (2 min each) a) Pavanamuktasana b) Viparitakarani mudra c) Setubandhasana d) Shavasana -3 - Yoga nidra 4 minutes III. KRIYA a) Kapalabhati 2 minutes IV. PRANAYAMA 6 min (2 min each) a) Suryanulomaviloma b) Bhastrika c) Ujjayi V. PRANAVA JAPA (AUM CHANTING) 5 min a) A-9 times b) U-9 times c) M-9 times d) AUM-9 times |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of Major Depressive Disorder as per ICD-10: moderate depression and HDRS (14-23): Mild to Moderate Depression
Patients willing to participate in the study and give informed written consent |
|
| ExclusionCriteria |
| Details |
Patients suffering from any other known cardio respiratory, neurological or endocrinological, systemic disorders as assessed by history and detailed clinical examination
Patients suffering from other psychiatric disorders: alcohol/substance abuse, psychotic features, suicidal tendency
Female patients who are pregnant or lactating
Patients with contraindications for TMS: Major head injury, epilepsy, metallic implants in head and neck areas
Patients who have completed participation in any other clinical trial during the past six (06) months and any other condition which the Investigators think may jeopardize the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To understand the role of Brain dynamic changes as biomarker for treatment response in MDD using EEG |
Baseline
1st month
2nd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To understand the role of Brain dynamic changes as biomarker for treatment response in MDD using TMS and HRV |
Baseline
1st month
2nd month |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
21/07/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Major Depressive Disorder (MDD) is a pervasive mental health condition that affects millions of individuals worldwide, contributing to a significant global burden of disease. While traditional treatments like psychotherapy and pharmacotherapy have demonstrated efficacy, a growing body of research suggests that complementary therapies, such as yoga, may offer additional benefits in managing the symptoms of MDD. This study aims to understand the neurophysiological basis of treatment response using complementary yoga therapy using neuroplasticity, specifically focusing on cortical plasticity measures, to explore how yoga as a complementary therapy may influence the brain’s adaptive capacity in individuals with MDD |
|