| CTRI Number |
CTRI/2025/12/099810 [Registered on: 24/12/2025] Trial Registered Prospectively |
| Last Modified On: |
17/12/2025 |
| 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
|
How Meditation Helps People with Asthma Breathe Better. |
|
Scientific Title of Study
|
EFFECT OF CYCLIC MEDITATION ON PULMONARY FUNCTION AND PSYCHOLOGICAL PARAMETERS IN PATIENTS WITH BRONCHIAL ASTHMA - 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 Ashwini A |
| Designation |
MD Scholar |
| Affiliation |
SDM College of Naturopathy and Yogic Sciences |
| Address |
Department of Yoga Therapeutics SDM College of Naturopathy and Yogic Sciences, Ujire, Dakshina Kannada
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
6361577190 |
| Fax |
|
| Email |
ashwinisanu09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwini A |
| Designation |
MD Scholar |
| Affiliation |
SDM College of Naturopathy and Yogic Sciences |
| Address |
Department of Yoga Therapeutics SDM College of Naturopathy and Yogic Sciences, Ujire, Dakshina Kannada
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
6361577190 |
| Fax |
|
| Email |
ashwinisanu09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivaprasad Shetty |
| Designation |
Dean and Professor |
| Affiliation |
SDM College of Naturopathy and Yogic Sciences |
| Address |
Department of Yoga Therapeutics SDM College of Naturopathy and Yogic Sciences, Ujire, Dakshina Kannada
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9731854585 |
| Fax |
|
| Email |
drshivapshetty70@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM Multi-Speciality Hospital, Ujire, Belthangady Taluk, Dakshina Kannada District, Karnataka, India – 574240 |
|
|
Primary Sponsor
|
| Name |
Dr Ashwini A |
| Address |
Department of Yoga Therapeutics SDM College of Naturopathy and Yogic Sciences, Ujire, Dakshina Kannada, Karnataka 574240 |
| Type of Sponsor |
Other [Self] |
|
|
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 Ashwini A |
SDM Multi-Speciality Hospital |
Department of General Medicine OPD 1 (room 1)
Dakshina Kannada
KARNATAKA |
6361577190
ashwinisanu09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J454||Moderate persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cyclic Meditation |
Participants will undergo a 35–40-minute Cyclic Meditation (CM) session daily for 4 weeks, along with standard care. Each session begins with Mandukya Upanishad chanting and Instant Relaxation Technique (IRT), followed by standing postures (Ardhakati Chakrasana, Padahastasana, and backbend) with relaxation pauses. This is followed by Quick Relaxation Technique (QRT), sitting postures (Shashankasana, Ustrasana), and ends with a 10-minute Deep Relaxation Technique (DRT), emphasizing relaxation, awareness, and slow mindful movements. |
| Comparator Agent |
Treatment-as-usual |
Treatment as usual (TAU) / Standard medical care for the condition, as prescribed by the treating physician, without any additional yoga or meditation intervention for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 19 to 50 years.
2. Gender of Both male and female subjects
3. 2 to 6 exacerbations in the previous year
4. Patients with a history of asthma or other typical clinical symptoms associated with respiratory issues
5. Asthma control questionnaire, ACQ 6 score more than or equal to 1.5 atleast twice throughout the screening
6. People with asthma of any duration, severity, and ethnicity.
7. Willingness to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Evidence of comorbidities like HIV and AIDS.
2. Presence of psychiatric co morbidity.
3. Other neurological diseases.
4. Other serious systemic illness, e.g. hepatic, renal, cardiac or CNS major psychiatric illness
5. Valvular diseases and respiratory disorders like Bronchiectasis, Cystic fibrosis, and Pneumothorax
6. Smoker within the past 6 months.
7. Recent surgery.
8. Patients participating in other studies. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pulmonary function tests(PFTs)
forced vital capacity (FVC)
forced expiratory volume in one second (FEV1)
Their ratio (FEV1/FVC)
Peak expiratory flow rate (PEFR) |
Pre, Post |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Pittsburgh Sleep Quality Index (PSQI)
2. Hamilton Anxiety Rating Scale (HAM-A) |
Pre, Post |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/01/2026 |
| 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="2"
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
|
This study presents a randomized controlled trial evaluating the effects of cyclic meditation (CM) on pulmonary function and psychological parameters in 104 adults (19 to 50 years) with bronchial asthma, a widespread respiratory disease causing airway inflammation and significant morbidity globally and in India. Given the limitations of conventional pharmacotherapy, including inhaled corticosteroid side effects, CM a meditation practice based on the Mandukya Upanishad, offers potential benefits by enhancing vagal tone, reducing stress, and improving lung function, supported by prior research. Study participants with ACQ 6 scores more than or equal to 1.5 and 2 to 6 exacerbations per year, excluding those with major comorbidities and smokers, will be randomized to either a CM intervention group or control. The CM intervention consists of 35 to 40 minute sessions, for four weeks. Primary outcomes include pulmonary function tests (FVC, FEV1, FEV1/FVC ratio, PEFR), while secondary outcomes assess sleep quality (PSQI) and anxiety (HAM A). The study aims to establish CM as a beneficial complementary therapy in bronchial asthma management |