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CTRI Number  CTRI/2025/11/097328 [Registered on: 13/11/2025] Trial Registered Prospectively
Last Modified On: 13/11/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A Study on How Allergic Rhinitis Affects the Daily Life of People in Wardha District 
Scientific Title of Study   Quality of Life in Patients with Allergic rhinitis in Wardha District: An Observational Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrMegha Tidke 
Designation  Assistant Professor 
Affiliation  Mahatma Gandhi Ayurveda College hospital and Research Centre salod wardha 
Address  Room No 63 Shalakya Tantra OPD Mahatma Gandhi Ayurved Hospital Salod H Wardha Wardha MAHARASHTRA 422001 India

Wardha
MAHARASHTRA
442001
India 
Phone  8329011170  
Fax    
Email  megha.tidke61@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Musaffa Kausar Ayaz Khan 
Designation  Intern 
Affiliation  Mahatma Gandhi Ayurveda College hospital and Research Centre salod wardha 
Address  Room No 63 Shalakya Tantra OPD Mahatma Gandhi Ayurved Hospital Salod H Wardha Wardha MAHARASHTRA 422001 India

Wardha
MAHARASHTRA
442001
India 
Phone  9112892145  
Fax    
Email  musaffakausarkhan@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrMegha Tidke 
Designation  Assistant Professor 
Affiliation  Mahatma Gandhi Ayurveda College hospital and Research Centre salod wardha 
Address  Room No 63 Shalakya Tantra OPD Mahatma Gandhi Ayurved Hospital Salod H Wardha Wardha MAHARASHTRA 422001 India

Wardha
MAHARASHTRA
442001
India 
Phone  8329011170  
Fax    
Email  megha.tidke61@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha, Maharashtra,India. 442001  
 
Primary Sponsor  
Name  DrMegha Tidke 
Address  Room No 63 Shalakya Tantra OPD Mahatma Gandhi Ayurved Hospital Salod H Wardha Wardha MAHARASHTRA 422001 India  
Type of Sponsor  Other [Self] 
 
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 Megha Tidke  Mahatma Gandhi Ayurved College Hospital and Research Centre  Room No. 63 Shalakya Tantra OPD Salod Hirapur Wardha, Maharashtra,India. 442001
Wardha
MAHARASHTRA 		 08329011170

megha.tidke61@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  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. Ayurveda Condition: VATAJAPRATISYAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Age of patients between 19 to 50 years
Residents of Wardha district
Willingness to give informed consent
Patients diagnosed as a case of VatajaPratishyaya(Allergic Rhinitis ICD-10 code J 30.9 will be selected irrespective of gender occupation and socio-economic status
Patients who can wait in queue for a followup assessment
 
 
ExclusionCriteria 
Details  1. Patients having other chronic respiratory diseases like asthma.
2. Patients suffering from cognitive impairments that make them unable to administer the Questionnaire.
3. Patients who are already participating in other clinical trials.
4. Patients with existing allergic conditions unrelated to allergic rhinitis.
5. Patients who cannot provide informed consent.
6. Patients with a history of nasal surgery or trauma
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
determine the prevalence of Allergic Rhinitis among the population residing in the Wardha district.
2. To assess the severity of Allergic Rhinitis symptoms, including their interference with daily activities, sleep, and psychological well-being.
 		 12 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
To Determine the Prevalence of Allergic Rhinitis on patients Quality of Life Using RQLQ scale
To assess the severity of Allergic Rhinitis symptoms including their intrference with daily activities sleep & psycological well being
 		 12 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/01/2026 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

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

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [megha.tidke61@gmail.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 01-06-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This observational study titled “Quality of Life in Patients with Allergic Rhinitis in Wardha District aims to assess how allergic rhinitis affects the daily lives of individuals in the region. Conducted at local health centers in Wardha, the study includes 100 participants aged 19–50 years who are diagnosed with allergic rhinitis (Vataja Pratishyaya). Using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), the research evaluates the impact of symptoms on daily activities, sleep, and emotional well-being. The study highlights the increasing prevalence of allergic rhinitis in rural areas due to environmental factors and aims to provide insights for better management and improved patient quality of life. 
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