The Treatment of Moderate to Severe Allergic Rhinitis With Electroacupuncture Combined With Microneedle Knife

March 27, 2025 updated by: Pengfei Qiu

A Clinical Randomized Controlled Study of Electroacupuncture Combined With Microneedle Knife in the Treatment of Moderate to Severe Allergic Rhinitis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou City, Zhejiang, China, 310030
        • Recruiting
        • Zhejiang Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cetirizine hydrochloride tablets combined with nasal budesonide spray group
The control group will be given oral cetirizine hydrochloride tablets and nasal budesonide spray with the following dosage: the starting dose is 2 sprays in each nostril twice daily, which is reduced to 1 spray in each nostril twice daily after 3 days, and then change to 1 spray once daily after 1 week, which will be used as the maintenance dose for a total of 4 weeks of treatment.
Drug: Cetirizine hydrochloride tablets combined with nasal budesonide spray.
Cetirizine hydrochloride tablets (specification: 10mg*24 tablets, Suzhou Sinochem Pharmaceutical Industry Co., Ltd., State Pharmaceutical License: H20030447) shall be given, 1 tablet daily. At the same time, nasal budesonide spray (specification: 64μg*120 sprays, AstraZeneca Pharmaceuticals Co., Ltd, State Pharmaceutical License: J20090079) shall be used: the starting dose shall be 2 sprays in each nostril twice a day, and after 3 days, it shall be reduced to 1 spray in each nostril twice a day, and then changed to 1 spray once a day after 1 week, which shall be used as the maintenance dose. The dosage will be increased or decreased at the patient's discretion according to the symptomatic condition during the course of treatment for a total of 4 weeks of treatment and observation. No other drugs for allergic rhinitis will be used during the treatment period.
Experimental: Electroacupuncture combined with Microneedle knife group
Subjects in this group will be treated with Electroacupuncture combined with Microneedle knife.The treatment time is 30 minutes each time, once every other day, and the treatment is carried out 3 times a week for 4 consecutive weeks, for a total of 12 treatments.
Other: Electroacupuncture combined with Microneedle Knife
The patient takes the supine position, the acupoints take bilateral Yingxiang acupoints and upper Yingxiang acupoints, the tip of the needle is stabbed obliquely towards the root of the nose for 5-10mm, to the extent that there is a feeling of soreness and distension in the nose, and perform the flat tonic and flat cathartic method, the waveform of electroacupuncture is selected as sparse and dense wave, the frequency is 2/100Hz, the strength of the current is taken as the degree that the patient can tolerate it, and the time of energizing is 30min; and then the patient takes the seated position, with his head hanging down low on the therapeutic pillow, and the therapeutic point of occipitocervical segment is selected, Then the patient is placed on the therapeutic pillow in a sitting position with the head hanging low, the treatment point of the occipitocervical segment is selected, the treatment point of the cervicothoracic junction is marked, and the micro-needle knife cuts and loose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Nasal Symptom Score
Time Frame: 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.
This scale will be performed by two trained raters to perform a Total Nasal Symptom Score#TNSS#, usually in the form of conversation and observation. After the examination, the two raters will score independently.TNSS score of 0 to 16 values, and higher scores mean a worse outcome.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood serum
Time Frame: In the early morning at fasting state before and after 4 weeks of treatment
In both groups, 5 mL of elbow venous blood will be drawn at room temperature in the early morning at fasting state before and after 4 weeks of treatment, and the serum will be separated by centrifugation at 3000 r/min for 15 min, and then stored in a refrigerator at -70℃ for measurement. Serum Eotaxin, Inter Cellular Adhesion Molecule-1(ICAM-1) and Eosinophil Cationic Protein(ECP) expression levels will be measured by enzyme-linked immunosorbent assay (ELISA).
In the early morning at fasting state before and after 4 weeks of treatment
Total Non-nasal Symptom Score
Time Frame: 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.
This scale will be performed by two trained raters to perform a Total Non-nasal Symptom Score#TNNSS#, usually in the form of conversation and observation. After the examination, the two raters will score independently.TNNSS score of 0 to 5 values, and higher scores mean a worse outcome.
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.
Rhinitis Quality of Life Questionnaire
Time Frame: 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.
This scale will be performed by two trained raters to perform a Rhinitis Quality of Life Questionnaire Score#RQLQ#, usually in the form of conversation and observation. After the examination, the two raters will score independently.RQLQ score of 0 to 144 values, and higher scores mean a worse outcome.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pengfei Qiu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 11, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 16, 2025

First Submitted That Met QC Criteria

March 16, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 27, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025ZR001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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