Clinical trial NCT06890260: The Treatment of Moderate to Severe Allergic Rhinitis With Electroacupuncture Combined With Microneedle Knife
Official title: A Clinical Randomized Controlled Study of Electroacupuncture Combined With Microneedle Knife in the Treatment of Moderate to Severe Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Allergic Rhinitis (Disorder)
Electroacupuncture
Microneedle Knife
Lead sponsor: Zhejiang Hospital
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Based on the inclusion and exclusion criteria, patients with allergic rhinitis who meet the requirements are selected as trial subjects, and the efficacy is clarified in a randomized controlled design trial. We will Use the total nasal symptom score as the primary outcome index, serum chemokine, intercellular adhesion molecule-1, eosinophil cationic protein, total non-nasal symptom score, and rhinitis-related quality of life scale as secondary outcome indexes, and oral cetirizine hydrochloride tablets and nasal budesonide spray as the control group, the efficacy of the subjects in the electroacupuncture combined with microneedle knife group and the drug group will be observed respectively before treatment, after 2 weeks of treatment, after 4 weeks, 1 month follow-up after the end of treatment, and 3 months follow-up after the end of treatment. 4 weeks later, 1 month follow-up after the end of treatment and 3 months follow-up after the end of treatment.


Eligibility criteria: Inclusion Criteria:

1. Those with clinical and laboratory diagnosis of moderate to severe allergic rhinitis;
2. Aged ≥18 years and ≤75 years, with no restriction on gender or ethnicity;
3. Not taking drugs such as antihistamines or nasal steroids within 1 month before enrollment;
4. Those who voluntarily participated in this study and signed an informed consent form, and who were able to adhere to outpatient treatment for 4 weeks.

Exclusion Criteria:

1. Atrophic rhinitis, hypertrophic rhinitis, vasomotor rhinitis, acute and chronic sinusitis, nasal polyps, severe septal deviation, eosinophilia non-allergic rhinitis;
2. Those with other allergic diseases such as asthma, urticaria, and colds that cause nasal congestion, runny nose, and sneezing;
3. Those who have serious diseases such as cardiovascular, cerebrovascular, hepatic, renal and hematopoietic systems in combination;
4. Pregnant or lactating women, psychiatric patients, patients with malignant tumors.

Primary outcomes:
measure: Total Nasal Symptom Score
timeFrame: TNSS will be performed at the baseline (pre-treatment), the 2 week after intervention,the 1 month after intervention,the 1 month follow-up and the 3 month follow-up to evaluate the severity of the disease and the treatment effect.
Secondary outcomes:
measure: Total Non-nasal Symptom Score
timeFrame: TNNSS will be performed at the baseline (pre-treatment), the 2 week after intervention,the 1 month after intervention,the 1 month follow-up and the 3 month follow-up to evaluate the severity of the disease and the treatment effect.
measure: Rhinitis Quality of Life Questionnaire
timeFrame: RQLQ will be performed at the baseline (pre-treatment), the 2 week after intervention,the 1 month after intervention,the 1 month follow-up and the 3 month follow-up to evaluate the severity of the disease and the treatment effect.
measure: blood serum
timeFrame: In the early morning at fasting state before and after 4 weeks of treatment
Other outcomes:
Locations:
city: Hangzhou City
country: China
facility: Zhejiang Hospital
state: Zhejiang
Study officials:
References: