| CTRI Number |
CTRI/2025/06/088902 [Registered on: 16/06/2025] Trial Registered Prospectively |
| Last Modified On: |
14/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A pilot Study on Hatha yoga and Bhakti Yoga for improving attention and Emotional well being in Adult with Attention Deficit Hyperactive Disorder |
|
Scientific Title of Study
|
Development, Validation and Comparative Efficacy Testing of a Hatha yoga protocol with a Bhakti Yoga protocol for Clinical Management of Adults diagnosed with Attention Deficit Hyperactivity Disorders (ADHD): A Randomized Controlled Pilot 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 |
Ram Bokde |
| Designation |
Md Yoga scholar |
| Affiliation |
Swami Vivekananda Yoga Anusandhana Samsthana Deemed to be university |
| Address |
Room Number 1, Arogyadhama Prashanti Kutiram, Vivekananda Road Kalluballu Post Jigani Anekal Bengaluru
Room Number 1, Arogyadhama Prashanti Kutiram, Vivekananda Road Kalluballu Post Jigani Anekal Bengaluru
Bangalore
KARNATAKA
560105
India |
| Phone |
9301862389 |
| Fax |
|
| Email |
rambokde720@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Hemant Bhargav |
| Designation |
Associate Professor of integrative medicine National Institute of Mental Health and Neurosciences |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
Room Number 2 Yoga Centre Integrative Medicine Department National Institute of Mental Health science Hosur Road Bangalore
Room Number 2 Yoga Centre Integrative Medicine Department National Institute of Mental Health science Hosur Road
Bangalore
KARNATAKA
560029
India |
| Phone |
08762019348 |
| Fax |
|
| Email |
drbhargav.nimhans@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ram Bokde |
| Designation |
Md Yoga scholar |
| Affiliation |
Swami Vivekananda Yoga Anusandhana Samsthana Deemed to be university |
| Address |
Room Number 1, Arogyadhama Prashanti Kutiram, Vivekananda Road Kalluballu Post Jigani Anekal Bengaluru
Room Number 1, Arogyadhama Prashanti Kutiram, Vivekananda Road Kalluballu Post Jigani Anekal Bengaluru
Bangalore
KARNATAKA
560105
India |
| Phone |
09301862389 |
| Fax |
|
| Email |
rambokde720@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swami Vivekananda Yoga Anusandhana Samsthana,Kalluballu post,Jigani,Anekal,Bengaluru 560105,India |
|
|
Primary Sponsor
|
| Name |
Swami Vivekananda Yoga Anusandhana Samsthana |
| Address |
Prashanti Kutiram Vivekananda Road Kalluballu Post Jigani Anekal Bengaluru 560105 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ram Bokde |
Arogyadhama Integrative Medicine Hospital ,Swami Vivekananda Yoga Anusandhana Samsthana |
Doctor of Medicine, School of Yoga and Naturopathy, Prashanti Kutiram Vivekananda Road Kalluballu Post Jigani Anekal Bengaluru 560105 Karnataka,India
Bangalore
KARNATAKA |
09301862389
rambokde720@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IEC SVYASA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F909||Attention-deficit hyperactivity disorder, unspecified type, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
add-on Hatha yoga for one group
AND ADD-ON Bhakti yoga for second group
Health education for control group |
tHIS IS AS AN ADD-ON TO TREATMENT AS USUAL - Each consisting of 20 participants, will engage in yoga interventions over an 8-week period. The first group will practice hatha yoga, the second group will participate in bhakti yoga. Third group will be an active control-arm to match therapist patient interactions and only health education will be given. The interventions will be conducted both offline and online,1-session offline under supervision, remaining session online for each group, total 24 session for each group. |
| Comparator Agent |
TREATMENT AS USUSAL |
MEDICATIONS (TAB METHYLPHENIDATE OR ATMOXETINE) PLUS USUAL PSYCHOSOCIAL SUPPORT |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Those diagnosed with adult ADHD by a psychiatrist according to DSM criteria.
2.Aged between 18 to 40 years.
3. Those with ability and fitness to practice prescribed yoga.
4. Ready to abstain from substances on the day of testing.
|
|
| ExclusionCriteria |
| Details |
1. Less than 14 on the Adult ADHD Self-Report Scale, screener items, ASRS-A .
2. Other physical or neurological condition and learning differences that make practice of yoga difficult.
3. Those with severe psychiatric comorbidities such as severe depression or anxiety
with suicidal ideations, those with psychosis or severe substance use disorders or cognitive impairment due to other causes.
4. Those on conventional structured psychotherapy.
5. Those with a change in medications in the last 8 weeks or in whom the change would be required in the next 8 weeks
6. Patient with current participation in regular yoga practices.
7. Patients with inability or unwilling to attain regular raj yoga or bhakti yoga practices.
|
|
|
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 check the feasibility and compare preliminary effectiveness of the developed Hatha yoga protocol with the Bhakti protocol in a pilot randomized controlled trial.
|
Two time point Baseline and 8 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To study the changes in the following variables when Hatha Yoga or Bhakti Yoga protocol is added along with conventional pharmacological management for adults with ADHD. Both immediate effects as well as effect of 8-week protocol on selected variables:
• Clinical symptoms on ASRS scale at 0 and 8 weeks
• Impulsivity Stop signal task at 0 and immediate and 8 weeks
• Quality of life WHOQOL BREF at 0 and 8 weeks
• Depression on HAMD scale and Anxiety on HAMA 0 and 8 weeks
• State anxiety STAI-X1 at 0 and immediate effect
• Work and social adjustment scale WSAS at 0 and after 8 weeks
• Kesebir Emotional style questionnaire KESQ
|
Pre data collection at baseline
Post-data collection after 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/07/2025 |
| 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="1"
Months="0"
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
|
Title of study is Development, Validation and Comparative Efficacy Testing of a Hatha yoga protocol with a Bhakti Yoga protocol for Clinical Management of Adults diagnosed with Attention Deficit Hyperactivity Disorders a Randomized Controlled Pilot Trial .Very few studies have assessed effects of yoga intervention in Adult ADHD. Yoga is culturally accepted, cost-effective, self-administrable, and adaptable for long-term care. There is an absence of standardized and validated yoga protocol for adult ADHD which leads to inconsistency and challenges in comparing results. Application of Yoga practice for enhancing determination and willpower as Hatha Yoga and Yoga philosophy and practice for culturing of emotions (Bhakti Yoga) has not been compared before in this population. Primary outcome of study to check the feasibility and compare preliminary effectiveness of the developed Hatha yoga protocol with the Bhakti protocol in a pilot randomized controlled trial. To study the changes in the variables example quality of life, clinical symptoms in attention deficit hyperactive disorder in adult ,impulsivity anxiety and depression score as comorbidity when Hatha Yoga or Bhakti Yoga protocol is added along with conventional pharmacological management for adults with ADHD. This is prospective three-arm randomized controlled design. Total sample size is 60. Each group consisting of 20 participants, will engage in yoga interventions over an 8-week period. The first group will practice hatha yoga, the second group will participate in bhakti yoga. Third group will be an active control-arm (to match therapist patient interactions) and only health education will be given. The interventions will be conducted both offline and online,1-session offline under supervision, remaining session online for each group, total 24 session for each group. |