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CTRI Number  CTRI/2026/01/102375 [Registered on: 28/01/2026] Trial Registered Prospectively
Last Modified On: 28/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [transauricular vagus nerve stimulation (TaVNS) ]  
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Vagus nerve stimulation in treatment of urticaria. 
Scientific Title of Study   A pilot interventional study evaluating transauricular vagus nerve stimulation (TaVNS) as adjunctive therapy in chronic spontaneous urticaria (CSU) 
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 Priyansh Gupta 
Designation  Assistant Professor 
Affiliation  ESIC Medical college and hospital, nit 3, faridabad 
Address  Room number 3, Dermatology OPD, 3rd floor, OPD building, ESIC Medical college and hospital, NIT-3, Faridabad, Haryana, 121001

Faridabad
HARYANA
121001
India 
Phone  7409401008  
Fax    
Email  priyansh.gupta2412222@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Priyansh Gupta 
Designation  Assistant Professor 
Affiliation  ESIC Medical college and hospital, nit 3, faridabad 
Address  Room number 3, Dermatology OPD, 3rd floor, OPD building, ESIC Medical college and hospital, NIT-3, Faridabad, Haryana, 121001

Faridabad
HARYANA
121001
India 
Phone  7409401008  
Fax    
Email  priyansh.gupta2412222@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Priyansh Gupta 
Designation  Assistant Professor 
Affiliation  ESIC Medical college and hospital, nit 3, faridabad 
Address  Room number 3, Dermatology OPD, 3rd floor, OPD building, ESIC Medical college and hospital, NIT-3, Faridabad, Haryana, 121001

Faridabad
HARYANA
121001
India 
Phone  7409401008  
Fax    
Email  priyansh.gupta2412222@gmail.com  
 
Source of Monetary or Material Support  
ESIC Medical college and hospital, NIT-3, Faridabad, Haryana, 121001  
 
Primary Sponsor  
Name  NIL 
Address  nil 
Type of Sponsor  Other [NONE] 
 
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 Priyansh Gupta  ESIC Medical college and hospital, NIT 3, Faridabad, Haryana, 121001  Room number 3, Dermatology opd , 3rd floor, OPD building
Faridabad
HARYANA 		 7409401008

priyansh.gupta2412222@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: L501||Idiopathic urticaria,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Tablet Levocetirizine   Tablet Levocetirizine 5mg one tablet at night which is standard regimen 
Intervention  Transauricular vagal nerve stimulation  Transauricular vagal nerve stimulation by device Transauricular vagal nerve stimulator (research grade) Each session at 25 Hertz for 30 minutes. Total of 8 sessions across 4 weeks (2 sessions per week) Alongwith tablet Levocetrizine as required for pruritis.Tablet count documented weekly. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adults with diagnosis of chronic spontaneous urticaria of duration six weeks or more.
Inadequate control on intermittent or standard dose antihistamines.
Willing and able to provide written informed consent. 
 
ExclusionCriteria 
Details  Physical urticarias, urticarial vasculitis, or predominant alternative dermatoses.
Cardiac pacemaker or defibrillator, seizure disorder, or implanted stimulators.
Pregnant or lactating women.
Severe comorbid systemic illnesses.
Local ear pathology preventing electrode placement. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Percentage of participants with 7 point or more decline in UAS 7 score at 8 weeks  8 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Difference in change in UCT in two groups  at 8 weeks 
Difference in change in DLQI in two groups  at 8 weeks 
Difference in change in CuQOL in two groups  at 8 weeks 
Change in weekly tablet count from baseline  at 8 weeks 
Laboratory parameters shift  at 8 weeks 
Relapse rate  at 8 weeks 
Safety events  at 8 weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   24/02/2026 
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="0"
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 - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [priyansh.gupta2412222@gmail.com].

  6. For how long will this data be available start date provided 24-02-2027 and end date provided 23-02-2032?
    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   This is a pilot study evaluating Transauricular Vagus Nerve Stimulation (TaVNS) as an adjunctive therapy to antihistamines for chronic spontaneous urticaria (CSU) in 40 patients over 12 months. The study is prospective, interventional, and controlled, assessing efficacy via UAS7 scores, quality-of-life measures, lab markers, and safety, with plans for statistical analysis and ethical compliance.
This 12-month pilot study with total 40 patients ( 30 intervention, 10 control) assesses TaVNS (left ear cymba concha, 25 hertz, 30 min for 8 sessions over 4 weeks) alongwith tablet levocetirizine as required versus levocetirizine alone in adults with CSU (more than 6 weeks duration, poor antihistamine response). Primary outcome of UAS7 reduction  of 7 or more points at week 8. Secondary outcomes of changes in QoL (DLQI, UCT, CuQOL), tablet count, laboratory parameters, relapse rate and safety events.
 
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