Seasonal Allergic RhinitisNCT04815668
Acupuncture at the Sphenopalatine Ganglion in the Treatment of Moderate-to-severe Seasonal Allergic Rhinitis
A study testing Acupuncture group and Rescue medication group in people with Seasonal Allergic Rhinitis, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
Allergic rhinitis (AR) is an immunoglobulin E-mediated inflammatory disease1 caused by hypersensitivity of the immune system to an allergen, affecting 100 million people in Europe 2and 400 million of the global population.The etiology of AR is multifactorial, resulting primarily from genetic predisposition… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Acupuncture group and Rescue medication group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 31 Dec 2026
- 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
- Age ≥18 years and ≤ 75 years;
- History of moderate to severe SAR symptoms (Visual analog scale(VAS) >50 mm, range, 0 cm[not at all bothersome] to 100 mm[extremely bothersome]) for more than 4 days/weeks, and more than 4 consecutive weeks with at least two years' duration;
- Positive skin prick test to grass and birch pollen or/and serum-specific IgE test;
- Ability to complete the medical information form and sign a written informed consent.
Who cannot join
- History or current evidence of perennial allergic rhinitis, acute sinusitis, allergic asthma, pneumonia; autoimmune disorders, or severe chronic inflammatory diseases;
- History of nasal rhinopolypus or abnormalities;
- Intake of antihistamines, anticholinergics, corticosteroids, decongestants, or antibiotics during the 1 month prior to beginning the study;
- History of systemically administered corticosteroids within 6 months or specific immunotherapy, allergy desensitization therapy within 1 year before enrollment;
- Serious uncontrolled blood coagulation disorder, cardiovascular disorder, severe hepatic/renal insufficiency or mental disorder;
- Pregnancy or planning for pregnancy;
- Known allergy, or contraindication to rescue medication or related drugs;
- Known phobia to acupuncture or having received acupuncture treatment, or sphenopalatine ganglion stimulation or other complementary and alternative medicine within 1 months prior to enrollment.
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
No.731 Hospital of China Aerospace Science and Industry Corporation
Beijing
Hui Chen
About this study
Official title: Effect of Acupuncture at the Sphenopalatine Ganglion in the Treatment of Moderate-to-severe Seasonal Allergic Rhinitis
Allergic rhinitis (AR) is an immunoglobulin E-mediated inflammatory disease1 caused by hypersensitivity of the immune system to an allergen, affecting 100 million people in Europe 2and 400 million of the global population.The etiology of AR is multifactorial, resulting primarily from genetic predisposition, immunological response, and environmental pollutants.AR traditionally has been classified as seasonal (SAR) or perennial (PAR) depending on the causes and duration of symptoms. Some patients with AR prefer complementary and alternative medicine for their symptoms, with nearly 20% receiving acupuncture. According to the updated practice parameter of rhinitis in 2020, the use of acupuncture for the treatment of AR was not recommended due to a lack of well-controlled studies.
The sphenopalatine ganglion (SPG), located under a thin (1-2 mm) layer of mucosa in the pterygopalatine fossa, consists of sensory fibers that innervate the nasopharynx, nasal cavity, and palate.Several studies have reported the benefit of SPG stimulation in chronic cluster headache and acute ischaemic stroke. Compared with traditional acupoints selected on basis of traditional meridian theory, acupuncture at SPG(inserting a needle through SPG acupoint (near ST7, Xiaguan) to reach and directly stimulate the SPG) may help patients ameliorate nasal symptoms immediately and improve quality of life by increasing sympathetic nerve excitability, but the evidence is inconclusive.
We have designed this three-armed, randomized trial to investigate the efficacy and safety of acupuncture at SPG for the treatment of SAR. We hypothesize that acupuncture at SPG plus rescue medication is superior to sham acupuncture plus RM and RM alone in the treatment of SAR.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Acupuncture group, Placebo acupuncture group, Rescue medication group
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture groupOther
Sterile single-use stainless steel needles (size 0.35 mm × 55 mm) (YiDaiFu brand, Suzhou Tianyi Acupuncture Instrument Co., Ltd., Suzhou, China) will be utilized. Participants in lateral position, the acupoints area will be sterilized with 75% alcohol. To stimulate SPG, the needles will be inserted in the medial superior anterior direction to a depth of approximately 55 mm33 until the participants report a special sensation radiating toward the nose or the upper teeth. After that, the needle will be withdrew slightly. The needles will be retained for 30 minutes after three stimulation. Rescue medication are permitted when participants feel that their symptoms are intolerable.
Placebo acupuncture groupOther
The acupuncture procedure will be similar to that of the acupuncture group. After sterilizing the skin, the 0.35 × 25 mm disposable needle will be vertically inserted at SPG acupoint about 3-5 mm. No needle manipulation will be conducted to avoid the deqi response. Rescue medication are permitted when participants feel that their symptoms are intolerable.
Rescue medication groupOther
Participants in the rescue medication group do not receive acupuncture treatment during the study period. They will be only allowed to use rescue medication. They have the option of 4 weeks (up to 8 sessions) of acupuncture free of charge at the end of the follow-up period.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture group | Experimental | Not described Receives: Other: Acupuncture group |
| Placebo acupuncture group | Placebo comparator | Not described Receives: Other: Placebo acupuncture group |
| Rescue medication | Other | Not described Receives: Other: Rescue medication group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline in the average daily Combined Symptoms and Medication Score (CSMS) over weeks 1- 4
The average daily Combined Symptoms and Medication Score (CSMS) is the sum of the daily symptom score (dSS) plus daily medication score (dMS) . The dSS contains a 6-item scale referring to nasal symptoms (4 items) and ocular symptoms (2 items), with each item scored using a Likert scale of 0 to 3. The dSS will be calculated as a mean of all non-missing dSS divided by the number of individual symptoms (range, o to 3). The dMS will again be calculated as an average of daily symptom relief medication score, with a range of 0 to 3.
Measured: weeks 1-4
Secondary outcomes (9)
The change from baseline in the average daily Combined Symptoms and Medication Score (CSMS) over weeks 5- 8 and the first week following symptoms onset in the second year
The average daily Combined Symptoms and Medication Score (CSMS) is the sum of the daily symptom score (dSS) plus daily medication score (dMS) . The dSS contains a 6-item scale referring to nasal symptoms (4 items) and ocular symptoms (2 items), with each item scored using a Likert scale of 0 to 3. The dSS will be calculated as a mean of all non-missing dSS divided by the number of individual symptoms (range, o to 3). The dMS will again be calculated as an average of daily symptom relief medication score, with a range of 0 to 3.
Measured: over weeks 5- 8 and the first week following symptoms onset in the second year
Change in the average daily symptom score (dSS) and daily medication score (dMS) from baseline over weeks 1- 4, weeks 5-8 in the first year and the first week following symptoms onset in the second year.
The daily symptom score (dSS) contains a 6-item scale referring to nasal symptoms (4 items) and ocular symptoms (2 items), with each item scored using a Likert scale of 0 to 3. The dSS will be calculated as a mean of all non-missing dSS divided by the number of individual symptoms (range, o to 3). The daily medication score (dMS) will again be calculated as an average of daily symptom relief medication score, with a range of 0 to 3.
Measured: over weeks 1- 4, weeks 5-8 in the first year and the first week following symptoms onset in the second year.
The proportion of participants with a minimum of 23% improvement in average daily Combined Symptoms and Medication Score (CSMS) from baseline over weeks 1-4, weeks 5-8 in the first year and at the first week following symptoms onset in the second year.
A difference of 23% on the average daily Combined Symptoms and Medication Score (CSMS) was chosen to demonstrate a minimum clinically important difference.
Measured: over weeks 1- 4, weeks 5-8 in the first year and the first week following symptoms onset in the second year.
Change in the Rhinoconjunctivitis Quality of Life Questionnaires (RQLQ) total score and subscale scores from baseline to the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year.
The RQLQ is a well-established and validated questionnaire consisted of 28 questions covering 7 domains: sleep (3 items), practical problems (3 items), non-nasal and eye symptoms (7 items), nasal symptoms (4 items), eye symptoms (4 items), activities that have been limited by nose or eye symptoms (3 items), and emotional function (4 items). Each item will be evaluated on a 7-point rating scale ranging from 0 (no impairment) to 6 (severe impairment) during the previous week.
Measured: At the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year
Change in the Visual analog scale score for the overall allergic symptoms severity from baseline to the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year.
Patients will be asked to grade the severity of allergic symptoms using the self-rated 0-100mm Visual analog scale (0, no symptoms, to 100, worst-ever symptoms, in 1-point increment).
Measured: At the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year
A global evaluation in comparison to previous years by each participant at the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year.
Each participant will be asked the following question: ''Compared to your symptoms in previous grass pollen seasons, how have you felt overall in this grass pollen season? (Tick only one)". The possible answers are coded as follows：1, "Very much better"; 2, "Much better"; 3, "A little better"; 4, "No change"; 5, "A little worse"; 6, "Much worse"; and 7, "Very much worse".
Measured: At the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year
Patient global evaluation of improvement at the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year.
Patient global evaluation of improvement will be rated by the participants using a 7-point Likert scale with the following options: 1, "Very much better"; 2, "Much better"; 3, "A little better"; 4, "No change"; 5, "A little worse"; 6, "Much worse"; and 7, "Very much worse" at each study visit.
Measured: At the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year
The average weekly number of medication-free days during weeks 1-4, weeks 5-8 in the first year.
The average weekly number of medication-free days during weeks 1-4, weeks 5-8 in the first year will be compared among three groups
Measured: during weeks 1-4, weeks 5-8 in the first year
The average weekly number of symptom-free days during weeks 1-4, weeks 5-8 in the first year.
The average weekly number of symptom-free days during weeks 1-4, weeks 5-8 in the first year will be compared among three groups
Measured: during weeks 1-4, weeks 5-8 in the first year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start1 May 2021
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal 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
- Participants who agreed to randomization will be allocated to the acupuncture group, sham acupuncture group or rescue medication group in a 1:1:1 ratio
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Aerospace 731 Hospital
- Responsible party
- Principal investigator, weiming wang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Weiming Wang, MD,PhD, Principal investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815668
- Sponsor's protocol ID
- 2020YK14
- Status last verified
- Jul 2025
- First submitted
- 23 Mar 2021
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupuncture at the Sphenopalatine Ganglion in the Treatment of Moderate-to-severe Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT04815668
- Acronym / sponsor ID
- 2020YK14
- Conditions
- Seasonal Allergic Rhinitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Aerospace 731 Hospital
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Mar 2021 (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.
Allergic rhinitis (AR) is an immunoglobulin E-mediated inflammatory disease1 caused by hypersensitivity of the immune system to an allergen, affecting 100 million people in Europe 2and 400 million of the global population.The etiology of AR is multifactorial, resulting primarily from genetic predisposition, immunological response, and environmental pollutants.AR traditionally has been classified as seasonal (SAR) or perennial (PAR) depending on the causes and duration of symptoms. Some patients with AR prefer complementary and alternative medicine for their symptoms, with nearly 20% receiving acupuncture. According to the updated practice parameter of rhinitis in 2020, the use of acupuncture for the treatment of AR was not recommended due to a lack of well-controlled studies.
The sphenopalatine ganglion (SPG), located under a thin (1-2 mm) layer of mucosa in the pterygopalatine fossa, consists of sensory fibers that innervate the nasopharynx, nasal cavity, and palate.Several studies have reported the benefit of SPG stimulation in chronic cluster headache and acute ischaemic stroke. Compared with traditional acupoints selected on basis of traditional meridian theory, acupuncture at SPG(inserting a needle through SPG acupoint (near ST7, Xiaguan) to reach and directly stimulate the SPG) may help patients ameliorate nasal symptoms immediately and improve quality of life by increasing sympathetic nerve excitability, but the evidence is inconclusive.
We have designed this three-armed, randomized trial to investigate the efficacy and safety of acupuncture at SPG for the treatment of SAR. We hypothesize that acupuncture at SPG plus rescue medication is superior to sham acupuncture plus RM and RM alone in the treatment of SAR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants who agreed to randomization will be allocated to the acupuncture group, sham acupuncture group or rescue medication group in a 1:1:1 ratio
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group | Experimental | Other: Acupuncture group |
| Placebo acupuncture group | Placebo comparator | Other: Placebo acupuncture group |
| Rescue medication | Other | Other: Rescue medication group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years and ≤ 75 years;
- History of moderate to severe SAR symptoms (Visual analog scale(VAS) >50 mm, range, 0 cm[not at all bothersome] to 100 mm[extremely bothersome]) for more than 4 days/weeks, and more than 4 consecutive weeks with at least two years' duration;
- Positive skin prick test to grass and birch pollen or/and serum-specific IgE test;
- Ability to complete the medical information form and sign a written informed consent.
Key exclusion criteria (8 listed)
- History or current evidence of perennial allergic rhinitis, acute sinusitis, allergic asthma, pneumonia; autoimmune disorders, or severe chronic inflammatory diseases;
- History of nasal rhinopolypus or abnormalities;
- Intake of antihistamines, anticholinergics, corticosteroids, decongestants, or antibiotics during the 1 month prior to beginning the study;
- History of systemically administered corticosteroids within 6 months or specific immunotherapy, allergy desensitization therapy within 1 year before enrollment;
- Serious uncontrolled blood coagulation disorder, cardiovascular disorder, severe hepatic/renal insufficiency or mental disorder;
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 |
|---|---|---|
| Acupuncture groupSterile single-use stainless steel needles (size 0.35 mm × 55 mm) (YiDaiFu brand, Suzhou Tianyi Acupuncture Instrument Co., Ltd., Suzhou, China) will be utilized. Participants in lateral position, the acupoints area will be sterilized with 75% alcohol. To stimulate SPG, the needles will be inserted in the medial superior anterior direction to a depth of approximately 55 mm33 until the participants report a special sensation radiating toward the nose or the upper teeth. After that, the needle will be withdrew slightly. The needles will be retained for 30 minutes after three stimulation. Rescue medication are permitted when participants feel that their symptoms are intolerable. | Other | Acupuncture group |
| Placebo acupuncture groupThe acupuncture procedure will be similar to that of the acupuncture group. After sterilizing the skin, the 0.35 × 25 mm disposable needle will be vertically inserted at SPG acupoint about 3-5 mm. No needle manipulation will be conducted to avoid the deqi response. Rescue medication are permitted when participants feel that their symptoms are intolerable. | Other | Placebo acupuncture group |
| Rescue medication groupParticipants in the rescue medication group do not receive acupuncture treatment during the study period. They will be only allowed to use rescue medication. They have the option of 4 weeks (up to 8 sessions) of acupuncture free of charge at the end of the follow-up period. | Other | Rescue medication |
Primary outcome
The change from baseline in the average daily Combined Symptoms and Medication Score (CSMS) over weeks 1- 4
Time frame: weeks 1-4
The average daily Combined Symptoms and Medication Score (CSMS) is the sum of the daily symptom score (dSS) plus daily medication score (dMS) . The dSS contains a 6-item scale referring to nasal symptoms (4 items) and ocular symptoms (2 items), with each item scored using a Likert scale of 0 to 3. The dSS will be calculated as a mean of all non-missing dSS divided by the number of individual symptoms (range, o to 3). The dMS will again be calculated as an average of daily symptom relief medication score, with a range of 0 to 3.
9 secondary outcomes
The change from baseline in the average daily Combined Symptoms and Medication Score (CSMS) over weeks 5- 8 and the first week following symptoms onset in the second year
Time frame: over weeks 5- 8 and the first week following symptoms onset in the second year
Change in the average daily symptom score (dSS) and daily medication score (dMS) from baseline over weeks 1- 4, weeks 5-8 in the first year and the first week following symptoms onset in the second year.
Time frame: over weeks 1- 4, weeks 5-8 in the first year and the first week following symptoms onset in the second year.
The proportion of participants with a minimum of 23% improvement in average daily Combined Symptoms and Medication Score (CSMS) from baseline over weeks 1-4, weeks 5-8 in the first year and at the first week following symptoms onset in the second year.
Time frame: over weeks 1- 4, weeks 5-8 in the first year and the first week following symptoms onset in the second year.
Change in the Rhinoconjunctivitis Quality of Life Questionnaires (RQLQ) total score and subscale scores from baseline to the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year.
Time frame: At the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year
Change in the Visual analog scale score for the overall allergic symptoms severity from baseline to the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year.
Time frame: At the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year
A global evaluation in comparison to previous years by each participant at the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year.
Time frame: At the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year
Patient global evaluation of improvement at the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year.
Time frame: At the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year
The average weekly number of medication-free days during weeks 1-4, weeks 5-8 in the first year.
Time frame: during weeks 1-4, weeks 5-8 in the first year
The average weekly number of symptom-free days during weeks 1-4, weeks 5-8 in the first year.
Time frame: during weeks 1-4, weeks 5-8 in the first year
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 16 Jul 2025.
- 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.
Weiming Wang, MD,PhD principal investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture group and Rescue medication group in people with Seasonal Allergic Rhinitis, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences 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 8 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 16 Jul 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. Some participants in this study may receive a placebo. 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 Weiming Wang, MD, PhD (010-88001830, wangweiming1a1@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change from baseline in the average daily Combined Symptoms and Medication Score (CSMS) over weeks 1- 4 (time frame: weeks 1-4). 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 16 Jul 2025.