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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [shreysk203@gmail.com].

  6. 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.

  7. 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).

 
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