Allergic RhinitisNCT07778537
AI-Guided Ultrasound Needling of Xinwu Point for Allergic Rhinitis
A study testing AI-guided Xinwu-point acupuncture and Blind Xinwu-point acupuncture in people with Allergic Rhinitis and Rhinitis, Allergic, run by Daxing Teaching Hospital, Capital Medical University at 1 site in China.
Trial summary
This study evaluated a new way to perform acupuncture at a deep point called the Xinwu point (sphenopalatine ganglion) for allergic rhinitis (hay fever-like nasal allergy). The point is hard to reach with the usual blind needling method. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Allergic Rhinitis, Rhinitis, Allergic
- What is being tested?
- AI-guided Xinwu-point acupuncture and Blind Xinwu-point acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2025to 8 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of allergic rhinitis according to the Chinese Guideline for the Diagnosis and Treatment of Allergic Rhinitis (2022, revised edition)
- Age 18 to 60 years
- No acupuncture or anti-allergic medication other than the study intervention within the preceding week
- Written informed consent and ability to complete treatment and follow-up
Who cannot join
- Serious underlying diseases of the heart, brain, liver, or kidney
- Systemic corticosteroid use or allergen immunotherapy within the preceding 3 months
- Other nasal disorders such as sinusitis, nasal polyps, or marked nasal septum deviation
- Coagulation abnormalities or long-term use of anticoagulants (e.g., warfarin or aspirin)
- Pregnancy, lactation, or planned pregnancy
- Impaired consciousness or verbal expression precluding cooperation with assessment
Trial locations and contacts
1 site in 1 country.
China1 site
Daxing Teaching Hospital of Capital Medical University
Beijing, Beijing Municipality, 102600
About this study
Official title: A Study of Artificial Intelligence-Assisted Visualization-Guided Acupuncture at the "Xinwu Point" for Allergic Rhinitis
This study evaluated a new way to perform acupuncture at a deep point called the Xinwu point (sphenopalatine ganglion) for allergic rhinitis (hay fever-like nasal allergy). The point is hard to reach with the usual blind needling method. Artificial intelligence (AI) with real-time ultrasound images was used to help the acupuncturist see nearby structures and guide the needle. Sixty adults were randomly assigned to AI-guided needling or usual blind needling. Both groups received the same acupuncture schedule: both sides of the face, once a week, for six sessions. The primary aim was to measure how accurately the needle reached the target. Side effects, nasal symptom scores, overall improvement, and how acceptable participants found the procedure were also recorded.
Read the detailed description
This was a single-center, parallel-group, randomized controlled trial conducted at Daxing Teaching Hospital of Capital Medical University (Beijing Daxing District People's Hospital), China, from September 2025 to May 2026.
Participants: 60 adults aged 18-60 years with allergic rhinitis diagnosed according to Chinese clinical guidelines were randomized 1:1 to an experimental group (AI-assisted ultrasound-guided needling) or a control group (conventional blind needling), 30 per group. All needling was performed by the same acupuncturist.
Intervention: Both groups received bilateral acupuncture at the Xinwu point (sphenopalatine ganglion) once every 7 days for 6 sessions. In the experimental group, a low-frequency ultrasound probe with an AI image-recognition program labeled anatomical landmarks (including the condylar process, coronoid process, neurovascular bundle, maxilla, and lateral pterygoid plate) in real time, and the needle was advanced in-plane to the pterygopalatine fossa. In the control group, the same needle type and success criteria were used without ultrasound or AI guidance.
Primary outcomes: needling success rate, first-pass success rate, and mean number of punctures.
Secondary outcomes: adverse-event rate, Total Nasal Symptom Score (TNSS), total effective rate based on TNSS improvement, and scores on a self-designed patient-acceptance scale.
This registration is retrospective because enrollment and follow-up were completed before the record was submitted.
- Conditions
- Allergic Rhinitis, Rhinitis, Allergic
- Being tested
- AI-guided Xinwu-point acupuncture, Blind Xinwu-point acupuncture
- Keywords
- acupuncture, sphenopalatine ganglion, Xinwu point, ultrasound guidance, artificial intelligence, needling accuracy
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-guided Xinwu-point acupunctureProcedure or surgery
Bilateral acupuncture at the Xinwu point (sphenopalatine ganglion) once every 7 days for 6 sessions, guided by ultrasound with an AI anatomical-recognition program. Disposable filiform needle 0.35 mm x 60 mm.
Blind Xinwu-point acupunctureProcedure or surgery
Bilateral acupuncture at the Xinwu point once every 7 days for 6 sessions using conventional surface-landmark blind needling. Same needle type and treatment schedule as the experimental arm.
| Study group | Role | What they receive |
|---|---|---|
| AI-guided needling | Experimental | AI-assisted real-time ultrasound visualization-guided acupuncture at the Xinwu point (sphenopalatine ganglion). Receives: Procedure: AI-guided Xinwu-point acupuncture |
| Conventional blind needling | Active comparator | Conventional blind acupuncture at the same Xinwu point without ultrasound or AI guidance. Receives: Procedure: Blind Xinwu-point acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Needling success rate
Percentage of punctures that successfully hit the sphenopalatine ganglion (Xinwu point), defined by an electric-shock-like or water-spray nasal sensation with rapid improvement in nasal ventilation. Calculated as successful hits divided by total punctures over 6 sessions (bilateral).
Measured: During 6 weekly treatment sessions, up to 6 weeks
First-pass success rate
Percentage of needling attempts that hit the target with a single puncture (no reinsertion).
Measured: During 6 weekly treatment sessions, up to 6 weeks
Mean number of punctures
Mean number of needle insertions required to achieve a successful hit of the Xinwu point (sphenopalatine ganglion).
Measured: During 6 weekly treatment sessions, up to 6 weeks
Secondary outcomes (4)
Adverse-event rate
Number of adverse events divided by total needling laterality-sessions (360 per group).
Measured: From first treatment through 1 week after the last session, up to 7 weeks
Change in Total Nasal Symptom Score (TNSS)
TNSS (0-16) for nasal congestion, itching, sneezing, and rhinorrhea.
Measured: Baseline and 1 week after the last session, up to 7 weeks
Total effective rate
Proportion of participants with TNSS improvement rate ≥26%.
Measured: 1 week after the last session
Patient-acceptance scale score
Total score (10-50) on a self-designed 10-item Likert acceptance scale.
Measured: Day 1, within 10 minutes after the first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start20 Sep 2025
- Primary completion8 Jun 2026
- Study completion8 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies 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
- Model description
- Two parallel groups: AI-guided needling versus conventional blind needling of the same acupoint.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daxing Teaching Hospital, Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Tan Che, Daxing Teaching Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778537
- Sponsor's protocol ID
- 20250812KY-YJ-30
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results of this study will be available from the corresponding author upon reasonable request after publication, subject to ethics committee approval and a data-use agreement. Data will not be posted in a public repository.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Artificial Intelligence-Assisted Visualization-Guided Acupuncture at the "Xinwu Point" for Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT07778537
- Acronym / sponsor ID
- 20250812KY-YJ-30
- Conditions
- Allergic Rhinitis, Rhinitis, Allergic
- Keywords
- acupuncture, sphenopalatine ganglion, Xinwu point, ultrasound guidance, artificial intelligence, needling accuracy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Daxing Teaching Hospital, Capital Medical UniversityUniversity, hospital or other
- Study start
- 20 Sep 2025 (actual)
- Primary completion
- 8 Jun 2026 (actual)
- Study completion
- 8 Jun 2026 (actual)
- First posted
- 21 Aug 2026 (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.
This study evaluated a new way to perform acupuncture at a deep point called the Xinwu point (sphenopalatine ganglion) for allergic rhinitis (hay fever-like nasal allergy). The point is hard to reach with the usual blind needling method. Artificial intelligence (AI) with real-time ultrasound images was used to help the acupuncturist see nearby structures and guide the needle. Sixty adults were randomly assigned to AI-guided needling or usual blind needling. Both groups received the same acupuncture schedule: both sides of the face, once a week, for six sessions. The primary aim was to measure how accurately the needle reached the target. Side effects, nasal symptom scores, overall improvement, and how acceptable participants found the procedure were also recorded.
Detailed description
This was a single-center, parallel-group, randomized controlled trial conducted at Daxing Teaching Hospital of Capital Medical University (Beijing Daxing District People's Hospital), China, from September 2025 to May 2026.
Participants: 60 adults aged 18-60 years with allergic rhinitis diagnosed according to Chinese clinical guidelines were randomized 1:1 to an experimental group (AI-assisted ultrasound-guided needling) or a control group (conventional blind needling), 30 per group. All needling was performed by the same acupuncturist.
Intervention: Both groups received bilateral acupuncture at the Xinwu point (sphenopalatine ganglion) once every 7 days for 6 sessions. In the experimental group, a low-frequency ultrasound probe with an AI image-recognition program labeled anatomical landmarks (including the condylar process, coronoid process, neurovascular bundle, maxilla, and lateral pterygoid plate) in real time, and the needle was advanced in-plane to the pterygopalatine fossa. In the control group, the same needle type and success criteria were used without ultrasound or AI guidance.
Primary outcomes: needling success rate, first-pass success rate, and mean number of punctures.
Secondary outcomes: adverse-event rate, Total Nasal Symptom Score (TNSS), total effective rate based on TNSS improvement, and scores on a self-designed patient-acceptance scale.
This registration is retrospective because enrollment and follow-up were completed before the record was submitted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two parallel groups: AI-guided needling versus conventional blind needling of the same acupoint.
| Arm | Type | Receives |
|---|---|---|
| AI-guided needling | Experimental | Procedure: AI-guided Xinwu-point acupunctureAI-assisted real-time ultrasound visualization-guided acupuncture at the Xinwu point (sphenopalatine ganglion). |
| Conventional blind needling | Active comparator | Procedure: Blind Xinwu-point acupunctureConventional blind acupuncture at the same Xinwu point without ultrasound or AI guidance. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosis of allergic rhinitis according to the Chinese Guideline for the Diagnosis and Treatment of Allergic Rhinitis (2022, revised edition)
- Age 18 to 60 years
- No acupuncture or anti-allergic medication other than the study intervention within the preceding week
- Written informed consent and ability to complete treatment and follow-up
Key exclusion criteria (6 listed)
- Serious underlying diseases of the heart, brain, liver, or kidney
- Systemic corticosteroid use or allergen immunotherapy within the preceding 3 months
- Other nasal disorders such as sinusitis, nasal polyps, or marked nasal septum deviation
- Coagulation abnormalities or long-term use of anticoagulants (e.g., warfarin or aspirin)
- Pregnancy, lactation, or planned pregnancy
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 |
|---|---|---|
| AI-guided Xinwu-point acupunctureBilateral acupuncture at the Xinwu point (sphenopalatine ganglion) once every 7 days for 6 sessions, guided by ultrasound with an AI anatomical-recognition program. Disposable filiform needle 0.35 mm x 60 mm. | Procedure or surgery | AI-guided needling |
| Blind Xinwu-point acupunctureBilateral acupuncture at the Xinwu point once every 7 days for 6 sessions using conventional surface-landmark blind needling. Same needle type and treatment schedule as the experimental arm. | Procedure or surgery | Conventional blind needling |
Primary outcome
Needling success rate
Time frame: During 6 weekly treatment sessions, up to 6 weeks
Percentage of punctures that successfully hit the sphenopalatine ganglion (Xinwu point), defined by an electric-shock-like or water-spray nasal sensation with rapid improvement in nasal ventilation. Calculated as successful hits divided by total punctures over 6 sessions (bilateral).
First-pass success rate
Time frame: During 6 weekly treatment sessions, up to 6 weeks
Percentage of needling attempts that hit the target with a single puncture (no reinsertion).
Mean number of punctures
Time frame: During 6 weekly treatment sessions, up to 6 weeks
Mean number of needle insertions required to achieve a successful hit of the Xinwu point (sphenopalatine ganglion).
4 secondary outcomes
Adverse-event rate
Time frame: From first treatment through 1 week after the last session, up to 7 weeks
Change in Total Nasal Symptom Score (TNSS)
Time frame: Baseline and 1 week after the last session, up to 7 weeks
Total effective rate
Time frame: 1 week after the last session
Patient-acceptance scale score
Time frame: Day 1, within 10 minutes after the first treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results of this study will be available from the corresponding author upon reasonable request after publication, subject to ethics committee approval and a data-use agreement. Data will not be posted in a public repository.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-guided Xinwu-point acupuncture and Blind Xinwu-point acupuncture in people with Allergic Rhinitis and Rhinitis, Allergic, run by Daxing Teaching Hospital, Capital Medical University 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 6 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: finished, as of the sponsor's last update on 21 Aug 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Needling success rate (time frame: During 6 weekly treatment sessions, up to 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2026.