| CTRI Number |
CTRI/2026/03/106158 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
11/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Other (Specify) [Paediatrics] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of yoga therapy in children with chronic sinusitis |
|
Scientific Title of Study
|
Yogic interventions as a complementary therapy for chronic rhinosinusitis in children 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 Athmika Shetty |
| Designation |
Assistant professor |
| Affiliation |
Division of Yoga, Centre for Integrative Medicine and Research, Manipal, Manipal Academy of Higher Education, Manipal |
| Address |
Division of yoga centre for integrative medicine and research near triveni centre MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9481951793 |
| Fax |
|
| Email |
shetty.athmika@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shrikiran A |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Manipal, MAHE, Manipal |
| Address |
Department of Paediatrics
Kasturba Medical College, Manipal,
MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448177671 |
| Fax |
|
| Email |
shrikiran.a@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shrikiran A |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Manipal, MAHE, Manipal |
| Address |
Department of Paediatrics
Kasturba Medical College, Manipal,
MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448177671 |
| Fax |
|
| Email |
shrikiran.a@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College Manipal Manipal academy of Higher
Education Madhavnagar Manipal udupi district India 576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal |
| Address |
Kasturba Medical College, Manipal, Manipal academy of Higher
Education, Madhavnagar, Manipal 576104 |
| 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 |
| Dr Athmika Shetty |
Kasturba Medical College Manipal |
Department of Paediatrics
Kasturba Medical College Manipal
MAHE, Manipal
Udupi
KARNATAKA |
9481951793
shetty.athmika@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J328||Other chronic sinusitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Care Control Group
|
Routine standard medical management as prescribed by the treating physician. |
| Intervention |
Yoga and Standard Care |
Asana pranayama and relaxation along with standard care for three months |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children diagnosed with Chronic Rhinosinusitis According to EPOS guidelines
Symptom duration less then twelve weeks despite standard medical treatment
|
|
| ExclusionCriteria |
| Details |
History of nasal or sinus surgery.
Major orthopaedic injuries prohibiting the performance of various yoga postures
Patients with known mental retardation and inability to practice yoga.
Individuals with K/C/O primary ciliary dyskinesia, immunodeficiency, craniofacial anomalies, and cystic fibrosis
K/C/O bronchial asthma on medication
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Symptom improvement assessed using the Total nasal symptom score (TNSS) |
baseline and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| QOL improvement measured using Sinonasal Quality of Life Survey (S N-5) |
baseline & 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="192"
Sample Size from India="192"
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)
|
01/04/2026 |
| 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="4"
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
|
This randomized controlled trial aims to evaluate the effectiveness of a structured yoga module as a complementary therapy in children aged 5–18 years diagnosed with chronic rhinosinusitis (CRS). Prior approvals will be obtained from IPAC, IEC, and CTRI. Eligible children attending the Paediatric OPD will be screened based on predefined criteria after obtaining written parental consent and child assent. Baseline assessment will include demographic data, medical history, and symptom evaluation using TNSS and SN-5 questionnaires. Participants will be randomized using computer-generated SNOSE technique into Control Group Standard medical care as prescribed. Intervention Group Standard care plus a structured yoga module (asana, pranayama, and relaxation), developed through expert opinion. The yoga intervention includes one initial supervised session followed by home practice (20 minutes/session, 4 days/week for 3 months), with bi-weekly live interactive monitoring and telephonic follow-ups for adherence and safety. A printed instruction booklet will be provided. Final assessment will be conducted at Week 12 using TNSS and SN-5. Secondary objectives include:
• Development and distribution of a structured online KAP questionnaire among pediatricians and ENT specialists across India to assess knowledge, attitude, and practices regarding CRS and yoga.
• Qualitative assessment of barriers, acceptability, and challenges in implementing yoga among children with CRS and their parents. Statistical analysis will be performed for quantitative data, and qualitative insights will be systematically documented. |