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Combined therapy of conventional drugs, acupoint injection, and neural regulation for allergic rhinitis: A study protocol for a randomized controlled trial

Combined therapy of conventional drugs, acupoint injection, and neural regulation for allergic rhinitis: A study protocol for a randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001964
Enrollment
Unknown
Registered
2025-10-22
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis (ICD-10: J30.4)

Interventions

Control group:Conventional medication + sham acupoint injection (saline) + sham taVNS stimulation
Drug + acupoint injection + sham taVNS group:Conventional medication + triamcinolone acupoint injection at ST36 + sham taVNS stimulation
Drug + sham acupoint + real taVNS group:Conventional medication + sham acupoint injection (saline) + real taVNS stimulation
Drug + acupoint injection + real taVNS group:Conventional medication + triamcinolone acupoint injection at ST36 + real taVNS stimulation

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1)Meet the diagnostic criteria for moderate-to-severe allergic rhinitis as defined in the "Chinese Guidelines for Diagnosis and Treatment of Allergic Rhinitis (2022, Revised Edition)", with a baseline TNSS = 6 during the screening period; 2)Aged between 18 and 65 years, male or female; 3)Conscious, cooperative, with good compliance, and without severe chronic or psychiatric diseases; 4)Considered suitable for the study by the principal investigator; 5)Voluntarily sign the informed consent form and agree to complete the entire follow-up process.

Exclusion criteria

Exclusion criteria: 1)Presence of acute or chronic sinusitis, otitis media, or other ENT infectious diseases; 2)History of sinus or nasal surgery within the past 6 months; 3)Drug-induced rhinitis or chronic epistaxis; 4)Severe nasal septal deviation or other significant anatomical abnormalities affecting respiration; 5)Severe respiratory, hematologic, cardiovascular, or psychiatric diseases; 6)Pregnant or lactating women, or those with skin ulcers, contact dermatitis, or other skin disorders; 7)Glucocorticoid-dependent patients, those who have received systemic corticosteroids within the past 4 weeks, or specific allergen immunotherapy within the past 6 months; 8)Currently receiving or previously received allergen immunotherapy; 9)Presence of implants such as cochlear implants, vagus nerve stimulators, or cardiac pacemakers; 10)Any other conditions deemed by the investigator to potentially affect participation or data interpretation.

Design outcomes

Primary

MeasureTime frame
Total Nasal Symptom Score (TNSS);Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ);

Secondary

MeasureTime frame
Total Ocular Symptom Score (TOSS);Serum Th1/Th2 cytokine levels;Total serum IgE and specific IgE;Peripheral blood eosinophil count;

Countries

China

Contacts

Public ContactYehai Liu

The First Affiliated Hospital of Anhui Medical University

liuyehai@ahmu.edu.cn+86 13856906986

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026