| CTRI Number |
CTRI/2026/03/106899 [Registered on: 25/03/2026] Trial Registered Prospectively |
| Last Modified On: |
24/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to evaluate whether VAJ Yoga improves mental health in people with depression. |
|
Scientific Title of Study
|
Effects of VAJ Yoga on Mental Health via Psychological, Electrophysiological, and Biochemical Indices in Patients having Depression |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Atulabh Vajpeyee |
| Designation |
Professor and Head of Department of Neurosciences |
| Affiliation |
Pacific Medical College and Hospital, Pacific Medical University |
| Address |
Bhilon ka Bedla, N.H. 27, Pratap Pura, Girwa, Udaipur, Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9460252872 |
| Fax |
|
| Email |
neuroresearchpmch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tushar Ameta |
| Designation |
Clinical Research Associate, Department of Neurosciences |
| Affiliation |
Pacific Medical College and Hospital, Pacific Medical University |
| Address |
Bhilon ka Bedla, N.H. 27, Pratap Pura, Girwa, Udaipur, Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
8094849002 |
| Fax |
|
| Email |
ametatushar20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jeshurun Mathew James |
| Designation |
Clinical Research Associate, Department of Neurosciences |
| Affiliation |
Pacific Medical College and Hospital, Pacific Medical University |
| Address |
Bhilon ka Bedla, N.H. 27, Pratap Pura, Girwa, Udaipur, Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9562562540 |
| Fax |
|
| Email |
work.jeshurun@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Neurosciences, Pacific Medical College and Hospital, Pacific Medical University, Bhilon ka Bedla, N.H. 27, Pratap Pura, Girwa, Udaipur, Rajasthan 313001 |
|
|
Primary Sponsor
|
| Name |
Pacific Medical College & Hospital, Pacific Medical University |
| Address |
Bhilon ka Bedla, N.H. 27, Pratap Pura, Girwa, Udaipur, Rajasthan 313001 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Tushar Ameta |
Pacific Centre of Neurosciences, Pacific Medical College and Hospital, Pacific Medical University |
Bhilon ka Bedla, N.H. 27, Pratap Pura, Girwa, Udaipur, Rajastha
Udaipur
RAJASTHAN |
8094849002
ametatushar20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee of PMCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F322||Major depressive disorder, singleepisode, severe without psychotic features, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Medical Treatment for Depression |
Participants in the comparator arm will receive standard medical treatment for depression as prescribed by the treating physician, including antidepressant medications and routine clinical care.
No yoga intervention will be provided to participants in the comparator group during the study period. |
| Intervention |
VAJ Yoga Program |
articipants in the intervention arm will receive a structured VAJ Yoga program in addition to standard medical treatment for depression. The VAJ Yoga program will consist of supervised sessions for 60 minutes daily, 7 days per week, for 12 weeks.
The intervention includes:
• Physical yoga postures (Asanas) – approximately 20 minutes
• Breathing exercises (Pranayama) including slow rhythmic breathing and alternate nostril breathing
• Raj Yoga meditation (Jeevan Dayi Shrestha) – approximately 40 minutes of guided open-eye meditation
Sessions will be conducted by a trained yoga instructor in a quiet environment. Participants will continue their prescribed antidepressant therapy without modification.
The control group will receive standard medical treatment alone without yoga intervention.
No experimental drug or device will be used in this study. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Male and female participants aged 18 to 80 years diagnosed with major depressive disorder with Hamilton Depression Rating Scale score greater than or equal to 20 receiving standard treatment and willing to participate in VAJ Yoga intervention for 12 weeks and able to provide written informed consent with no regular yoga practice in the last 6 months. |
|
| ExclusionCriteria |
| Details |
Patients with severe psychiatric disorders other than depression (e.g., schizophrenia, bipolar disorder, psychosis).
Patients with serious uncontrolled medical illnesses (e.g., severe cardiovascular disease, renal failure, liver disease, or malignancy).
Patients with neurological disorders affecting participation or EEG interpretation.
Patients with substance or alcohol dependence.
Patients who have regularly practiced yoga or meditation within the last 6 months.
Patients unable to participate in yoga sessions due to physical disability or severe illness.
Patients unwilling or unable to provide written informed consent.
Participants unlikely to complete the 12-week follow-up period. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in DASS-42 total score (Depression + Anxiety + Stress subscales) from baseline |
Change in DASS-42 total score (Depression + Anxiety + Stress subscales) from baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in HAM-D (Hamilton Depression Rating Scale) score from baseline |
Baseline (Week 0) and Week 12 |
| Change in Oxford Happiness Questionnaire (OHQ) score |
Baseline (Week 0) and Week 12 |
| Change in Emotional Quotient (EQ) score (NHS scale) |
Baseline (Week 0) and Week 12 |
| Change in Spiritual Quotient (SQ) score (SISRI-24) |
Baseline (Week 0) and Week 12 |
| Change in cognitive performance (WAIS-IV Digit Span / Working Memory index) |
Baseline (Week 0) and Week 12 |
| Change in quantitative EEG band power (alpha, beta, theta, delta) in frontal, parietal and temporal regions |
Baseline (Week 0) and Week 12 |
| Change in serum serotonin concentration |
Baseline (Week 0) and Week 12 |
| Change in serum dopamine concentration |
Baseline (Week 0) and Week 12 |
|
|
Target Sample Size
|
Total Sample Size="612"
Sample Size from India="612"
Final Enrollment numbers achieved (Total)= "502"
Final Enrollment numbers achieved (India)="502" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/04/2026 |
| Date of Study Completion (India) |
30/07/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [neuroresearchpmch@gmail.com].
- For how long will this data be available start date provided 20-06-2026 and end date provided 20-06-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study aims to evaluate the effect of a structured VAJ Yoga program on mental health in patients with depression. Participants aged 18 to 80 years with moderate to severe depression will be randomly assigned to receive VAJ Yoga therapy in addition to standard medical treatment or standard treatment alone for 12 weeks. The VAJ Yoga program includes physical postures breathing exercises and meditation for 60 minutes daily.
The primary objective is to determine whether VAJ Yoga improves depression anxiety and stress levels measured by the DASS 42 scale. Secondary objectives include assessment of Hamilton Depression Rating Scale scores happiness emotional quotient spiritual quotient cognitive performance EEG patterns and serum serotonin and dopamine levels.
The study hypothesis is that regular practice of VAJ Yoga in addition to standard treatment will improve psychological and neurophysiological outcomes in patients with depression compared to standard treatment alone. |