| CTRI Number |
CTRI/2024/03/064405 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
16/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Accupressure] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Utility of Manual Acupressure in Allergic Rhinitis |
|
Scientific Title of Study
|
Effect of Manual Acupressure as a Supplementary Therapy on Quality of Life in Patients of Allergic Rhinitis; a Randomised 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 |
Shreyaa Sampath Kumar |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
Department of Otorhinolaryngology,
Institute Block
JIPMER Campus
Dhanvantri Nagar
Pondicherry PONDICHERRY 605009 India |
| Phone |
9008150360 |
| Fax |
|
| Email |
shreysk203@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Kalaiarasi Raja |
| Designation |
Associate Professor |
| Affiliation |
JIPMER |
| Address |
Department of Otolaryngology,
Institute Block,
JIPMER Campus
Dhanvantri Nagar
PONDICHERRY 605006 India |
| Phone |
9489693249 |
| Fax |
|
| Email |
kalaiarasi004@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Kalaiarasi Raja |
| Designation |
Associate Professor |
| Affiliation |
JIPMER |
| Address |
Department of Otolaryngology,
Institute Block,
JIPMER Campus
Dhanvantri Nagar
PONDICHERRY 605006 India |
| Phone |
9489693249 |
| Fax |
|
| Email |
kalaiarasi004@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlala Institute of Postgraduate Medical Education and Research |
| JIPMER Intramural Research Fund |
|
|
Primary Sponsor
|
| Name |
JIPMER Intramural Research Fund |
| Address |
Jawaharlal Nehru Institute of Postgraduate Medical Education and Research, Dhanvantri Nagar |
| Type of Sponsor |
Government 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 Shreyaa Sampath Kumar |
Jawaharlala Institute of Postgraduate Medical Education and Research |
Jawaharlala Institute of Postgraduate Medical Eductaion and Research, Dhanvantri Nagar Pondicherry PONDICHERRY |
9008150360
shreysk203@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe, JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J309||Allergic rhinitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intranasal corticosteroid + Oral antihistamine |
Intranasal corticosteroid + Oral antihistamine for 6 weeks |
| Intervention |
Standard Therapy + Manual Accupressure |
Intranasal corticosteroid and Oral antihistamine + Self administered manual acupressure to 5 points for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Between the ages of 18 and 50 years
2. Clinically diagnosed as allergic rhinitis, as per ARIA guidelines and using Absolute Eosinophil Count
3. Symptom duration for more than 6 months
4. Moderate to severe allergic rhinitis (Visual Analogue Scale score of 30-70mm at baseline)
5. Symptoms severe enough to require oral antihistamines/intranasal corticosteroid usage
|
|
| ExclusionCriteria |
| Details |
1. Pediatric patients, less than 18 years of age
2. Patients with anatomical abnormality of nose (Deviated nasal septum, Concha bullosa etc)
3. Patients with diagnosed asthma or other chronic upper respiratory pathologies, parasitic infestations or immunological diseases
4. Pregnant and breastfeeding women
5. Patients on steroids or other immunosuppressive therapy for unrelated conditions
6. Patients using other complementary medicine systems during the study period
7. Contra-indication to cetirizine or inhalational steroid therapy
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in scores of quality of life questionnaires: NRQLQ, VAS, TNSS |
Improvement in scores of quality of life questionnaires: NRQLQ, VAS, TNSS at baseline, 4 weeks and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in total serum human immunoglobulin E (IgE) |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
27/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
27/03/2024 |
| 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)
|
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 - 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 Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shreysk203@gmail.com].
- For how long will this data be available start date provided 09-03-2026 and end date provided 09-03-2031?
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
|
Acupressure is a simple, non-invasive and
self-administered modality of treatment which has been explored in the
management of various conditions with varying degrees of success.
Studying the efficacy of acupressure as an
adjunctive therapy in allergic rhinitis could open the door to its integration
into the existing treatment rationale, subsequently reducing the disease burden
and improving quality of life and productivity, especially among the working
population. As of now, there are
few studies of good quality in this field, and none of those are from India. Expected Outcome:
Improvement in quality of life, and reduction in symptoms, as reflected by
questionnaire scores, in patients employing self-administered manual
acupressure in addition to standard therapy. After randomization and allocation,
patients belonging to the Standard Therapy Only (STO) group will be provided
with oral antihistamines (Cetirizine 10mg HS) and inhaled corticosteroid (Fluticasone
plus Azelastine nasal spray 1 puff in each nostril twice daily) prescriptions.
Patients belonging to Manual Acupressure (MAP)
group will be given oral antihistamines and inhalational corticosteroid. In
addition, they will receive an individual hands-on demonstration,lasting 20 to
30 minutes,of acupressure points and technique for self-administration of
acupressure, as well as a video demonstrating the same to them for domestic
use. This is to be self-administered for 20 minutes every day, applying enough
pressure so as to not cause pain.
After the baseline measurements, outcomes
will be measured at 4 weeks and 6 weeks, during in-person follow-up visit. This
will be done using standardized validated questionnaires i.e, Nocturnal
Rhinitis Quality of Life Questionnaire (NRQLQ), Visual Analogue Score (VAS) and
Total Nasal Symptom Score (TNSS). |