Allergic Rhinitis (Disorder)NCT06890260
The Treatment of Moderate to Severe Allergic Rhinitis With Electroacupuncture Combined With Microneedle Knife
A study testing Electroacupuncture combined with Microneedle Knife and Cetirizine hydrochloride tablets combined with nasal budesonide spray. in people with Allergic Rhinitis (Disorder) and Electroacupuncture, run by Pengfei Qiu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Allergic Rhinitis (Disorder), Electroacupuncture, Microneedle Knife
- What is being tested?
- Electroacupuncture combined with Microneedle Knife and Cetirizine hydrochloride tablets combined with nasal budesonide spray.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 11 Apr 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those with clinical and laboratory diagnosis of moderate to severe allergic rhinitis;
- Aged ≥18 years and ≤75 years, with no restriction on gender or ethnicity;
- Not taking drugs such as antihistamines or nasal steroids within 1 month before enrollment;
- 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.
Who cannot join
- Atrophic rhinitis, hypertrophic rhinitis, vasomotor rhinitis, acute and chronic sinusitis, nasal polyps, severe septal deviation, eosinophilia non-allergic rhinitis;
- Those with other allergic diseases such as asthma, urticaria, and colds that cause nasal congestion, runny nose, and sneezing;
- Those who have serious diseases such as cardiovascular, cerebrovascular, hepatic, renal and hematopoietic systems in combination;
- Pregnant or lactating women, psychiatric patients, patients with malignant tumors.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang Hospital
Hangzhou, Zhejiang, 310030
Pengfei Qiu, +8618158508449, 764360784@qq.com
About this study
Official title: 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.
- Being tested
- Electroacupuncture combined with Microneedle Knife, Cetirizine hydrochloride tablets combined with nasal budesonide spray.
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroacupuncture combined with Microneedle KnifeOther
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
Cetirizine hydrochloride tablets combined with nasal budesonide spray.Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Cetirizine hydrochloride tablets combined with nasal budesonide spray group | Experimental | 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. Receives: Drug: Cetirizine hydrochloride tablets combined with nasal budesonide spray. |
| Electroacupuncture combined with Microneedle knife group | Experimental | 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. Receives: Other: Electroacupuncture combined with Microneedle Knife |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Nasal Symptom Score
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.
Measured: 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 (3)
Total Non-nasal Symptom Score
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.
Measured: 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
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.
Measured: 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.
blood serum
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).
Measured: In the early morning at fasting state before and after 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start11 Apr 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic Rhinitis (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pengfei Qiu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pengfei Qiu, Zhejiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890260
- Sponsor's protocol ID
- 2025ZR001
- Status last verified
- Mar 2025
- First submitted
- 16 Mar 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qiu P, Wu X, Ye N, Zhou X, Zhu J, Zeng X. The efficacy of electroacupuncture combined with Micro-Needle-Knife for allergic rhinitis: study protocol for a randomized controlled trial. Front Med (Lausanne). 2026 Mar 13;13:1756690. doi: 10.3389/fmed.2026.1756690. eCollection 2026.
PubMed 41907282
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Randomized Controlled Study of Electroacupuncture Combined With Microneedle Knife in the Treatment of Moderate to Severe Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT06890260
- Acronym / sponsor ID
- 2025ZR001
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Pengfei QiuUniversity, hospital or other
- Study start
- 11 Apr 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cetirizine hydrochloride tablets combined with nasal budesonide spray group | Experimental | Drug: Cetirizine hydrochloride tablets combined with nasal budesonide spray.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. |
| Electroacupuncture combined with Microneedle knife group | Experimental | Other: Electroacupuncture combined with Microneedle KnifeSubjects 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Those with clinical and laboratory diagnosis of moderate to severe allergic rhinitis;
- Aged ≥18 years and ≤75 years, with no restriction on gender or ethnicity;
- Not taking drugs such as antihistamines or nasal steroids within 1 month before enrollment;
- 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.
Key exclusion criteria (4 listed)
- Atrophic rhinitis, hypertrophic rhinitis, vasomotor rhinitis, acute and chronic sinusitis, nasal polyps, severe septal deviation, eosinophilia non-allergic rhinitis;
- Those with other allergic diseases such as asthma, urticaria, and colds that cause nasal congestion, runny nose, and sneezing;
- Those who have serious diseases such as cardiovascular, cerebrovascular, hepatic, renal and hematopoietic systems in combination;
- Pregnant or lactating women, psychiatric patients, patients with malignant tumors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electroacupuncture combined with Microneedle KnifeThe 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 | Other | Electroacupuncture combined with Microneedle knife group |
| 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. | Drug | Cetirizine hydrochloride tablets combined with nasal budesonide spray group |
Primary outcome
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.
3 secondary outcomes
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.
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.
blood serum
Time frame: In the early morning at fasting state before and after 4 weeks of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Derived from this study: PubMed 41907282Qiu P, Wu X, Ye N, Zhou X, Zhu J, Zeng X. The efficacy of electroacupuncture combined with Micro-Needle-Knife for allergic rhinitis: study protocol for a randomized controlled trial. Front Med (Lausanne). 2026 Mar 13;13:1756690. doi: 10.3389/fmed.2026.1756690. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture combined with Microneedle Knife and Cetirizine hydrochloride tablets combined with nasal budesonide spray. in people with Allergic Rhinitis (Disorder) and Electroacupuncture, run by Pengfei Qiu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pengfei Qiu (+8618158508449, 764360784@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06890260, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.