Allergic Rhinitis Due to House Dust MiteNCT07452380
The Efficacy of Specific Immunotherapy Guided by Component-Resolved Diagnosis for Dust Mite Allergens in Chinese Pediatric Patients With Rhinitis and/or Asthma
An observational study of Allergic Rhinitis Due to House Dust Mite, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
This study is a Study to Understand How to Better Match Allergy Shots to a Child's Unique Mite Allergy Profile 1. Why is this study being done? For many children, tiny house dust mites are a major cause of persistent allergies, leading to uncomfortable symptoms like a stuffy nose, sneezing, and even asthma. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Allergic Rhinitis Due to House Dust Mite
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to 1 Nov 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: This study plans to recruit participants from multiple research centers across China between November 2025 and November 2028. The target population is children aged 5 to 18 years who have been confirmed as having dust mite allergy through allergen testing and are scheduled to receive subcutaneous specific immunotherapy with a dust mite dual-allergen preparation.
Who may be able to join
- -(1) Age: 5 years ≤ age < 18 years; (2) 1) Allergic rhinitis caused by Dermatophagoides pteronyssinus and/or Dermatophagoides farinae; 2) Or serum specific IgE ≥ 0.70 (kU/L) (for D. pteronyssinus and/or D. farinae); (3) Children meeting criteria (2) must undergo allergen component testing; (4) If accompanied by bronchial asthma, asthma must be diagnosed according to the Guidelines for the Diagnosis and Prevention of Childhood Bronchial Asthma (2025 edition) and the patient's asthma symptoms must be confirmed as well-controlled.
- Receiving treatment with dual-mite (Dermatophagoides pteronyssinus and farinae) subcutaneous immunotherapy (SCIT).
Who cannot join
- (1) Participants and/or their parents/legal guardians are judged by the investigator to be unable to fully understand the study requirements, or to adhere to long-term treatment and identify adverse reactions (including but not limited to conditions such as cognitive impairment or mental illness); (2) Children with severe or uncontrolled asthma (FEV1 < 70% of predicted value) or with irreversible airflow obstruction; (3) Children using beta-blockers or angiotensin-converting enzyme inhibitors (ACEI); (4) Children with severe autoimmune diseases or immunodeficiencies, including AIDS, inflammatory bowel disease, etc., as well as those currently using immunosuppressants; (5) Children with severe cardiovascular diseases or malignant tumors; (6) Children with incomplete clinical data.
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
The Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Yujia Xiao, PhD, 86+13397813805, hero.xiaoxiao@icloud.com
About this study
Official title: A Multicenter Registry Study Examining the Efficacy of Specific Immunotherapy Guided by Component-Resolved Diagnosis for Dust Mite Allergens in Chinese Pediatric Patients With Rhinitis and/or Asthma（EXPLORER STUDY）
This study is a Study to Understand How to Better Match Allergy Shots to a Child's Unique Mite Allergy Profile
- Why is this study being done? For many children, tiny house dust mites are a major cause of persistent allergies, leading to uncomfortable symptoms like a stuffy nose, sneezing, and even asthma. A common long-term treatment is allergy shots, also known as allergen immunotherapy (AIT). These shots work like a vaccine, slowly training the body's immune system to stop overreacting to mites. However, not every child responds to this treatment in the same way. The investigators now know that children can be allergic to different parts of the dust mite. While most treatments focus on the most common parts (called "major allergens"), some children are allergic to other, less common parts (called "intermediate or minor allergens"). The EXPLORER study wants to find out if a child's unique allergy profile-meaning which specific mite proteins they are allergic to-affects how well they respond to allergy shots. Our goal is to move away from a "one-size-fits-all" approach and toward more personalized care for children with dust mite allergies.
- Who is this study for? The investigators are looking for children and teenagers (ages 5 to 18) in China who have a confirmed dust mite allergy and are planning to start allergy shots.
- What will happen during the study? This is an "observational" study, which means the investigators will simply observe and track the progress of children who are already receiving a standard, approved allergy shot treatment as part of their regular medical care. The investigators won't be testing a new drug. Here's what participation involves: A Detailed Allergy Test: At the beginning, participants will have a special blood test. This test will look for allergies to nine different specific parts of the dust mite, giving us a very detailed map of their allergy. Grouping: Based on the results of this test, participants will be placed into different groups according to their specific allergy patterns. Tracking Progress: The investigators will follow their treatment journey for three years. The investigators will collect information at regular check-ups (at 0, 3, 6, 12, 24, and 36 months) on: How well their symptoms are controlled. How much allergy medication they need. Their overall quality of life. Any side effects from the shots. Annual Blood Tests: Once a year, the investigators will repeat the detailed blood test to see how their immune system is changing in response to the treatment.
- What do the investigators hope to learn? The investigators have a main theory, or hypothesis: Children who are allergic to many different parts of the dust mite (including the minor ones) will show greater improvement from the allergy shots, compared to children who are only allergic to the most common parts. By studying a large group of 1,000 children, the investigators hope to provide clear evidence that can help doctors choose the right treatment for the right child. This will help fill a current gap in medical guidelines and bring us closer to truly personalized treatment for pediatric allergies.
- Why is this study important? This is the first large-scale study of its kind in a real-world setting. The results could change how doctors diagnose and treat dust mite allergies in children. Instead of just knowing a child is allergic to mites, the investigators will be able to see the full picture of how they are allergic. This knowledge will help ensure that every child receives the treatment that gives them the best chance for long-term relief.
- Conditions
- Allergic Rhinitis Due to House Dust Mite
- Keywords
- House dust mite, allergic rhinitis, Component-Resolved Diagnosis, Allergen Immunotherapy, subcutaneous immunotherapy, asthma
- Medical subject headings
- Rhinitis, Allergic, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| major allergens group | The group containing only major allergen components detected by Component-Resolved Diagnosis | |
| intermediate/minor allergens group | The group containing intermediate/minor allergens with or without major components. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Changes of CSMS
the change from baseline in Combined Symptom and Medication Scores (CSMS). CSMS includes a symptom score and a medication score. The minimum value for the symptom score is 0 and the maximum is 3. The minimum value for the medication score is 0 and the maximum is 3. The combined score is the sum of these two scores, with a higher score indicating more severe symptoms.
Measured: evaluated at months 3, 6, 12, 24, and 36
Secondary outcomes (2)
serological markers
sIgE/sIgG4 ratios of HDM components
Measured: at years 1, 2, and 3
Visual Analog Scale (VAS) scores
the change from baseline in Visual Analog Scale (VAS) scores. The minimum value for the VAS is 0 and the maximum is 10, with a higher score indicating more severe symptoms.
Measured: evaluated at months 3, 6, 12, 24, and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Nov 2025
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Allergic Rhinitis Due to House Dust MiteStudies of the same condition, open and under way.
- More trials run by The Children's Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TANG LANFANG, The Children's Hospital of Zhejiang University School of Medicine
- Investigators
- Lanfang Tang, PhD, Study director, The Children's Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452380
- Sponsor's protocol ID
- 2025-IRB-0386-P-01
- Status last verified
- Mar 2026
- First submitted
- 1 Mar 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In the EDC system, only the data entry personnel at the principal investigator's site and sub-centers are permitted to input data, and only the data monitoring personnel are permitted to view it.
Publications
Schuster A, Caimmi D, Nolte H, Novakova S, Mikler J, Foss-Skiftesvik MH, Osterdal AS, Emeryk A, Gagnon R, Pfaar O. Efficacy and safety of SQ house dust mite sublingual immunotherapy-tablet (12 SQ-HDM) in children with allergic rhinitis/rhinoconjunctivitis with or without asthma (MT-12): a randomised, double-blind, placebo-controlled, phase III trial. Lancet Reg Health Eur. 2024 Nov 26;48:101136. doi: 10.1016/j.lanepe.2024.101136. eCollection 2025 Jan.
PubMed 39678704Rodriguez-Dominguez A, Berings M, Rohrbach A, Huang HJ, Curin M, Gevaert P, Matricardi PM, Valenta R, Vrtala S. Molecular profiling of allergen-specific antibody responses may enhance success of specific immunotherapy. J Allergy Clin Immunol. 2020 Nov;146(5):1097-1108. doi: 10.1016/j.jaci.2020.03.029. Epub 2020 Apr 13.
PubMed 32298697Gan H, Luo W, Huang Z, Zhang T, Hou X, Chen Y, Zhu Z, Sun B. House dust mite components sensitization profile in China, a multi-centre study. Clin Exp Allergy. 2023 Feb;53(2):226-229. doi: 10.1111/cea.14255. Epub 2022 Dec 15. No abstract available.
PubMed 36519672Chen KW, Zieglmayer P, Zieglmayer R, Lemell P, Horak F, Bunu CP, Valenta R, Vrtala S. Selection of house dust mite-allergic patients by molecular diagnosis may enhance success of specific immunotherapy. J Allergy Clin Immunol. 2019 Mar;143(3):1248-1252.e12. doi: 10.1016/j.jaci.2018.10.048. Epub 2018 Nov 14. No abstract available.
PubMed 30445063Luo W, Chen H, Cheng L, Cui Y, Guo Y, Gao Z, Guan K, Han K, Hong H, Ji K, Li J, Liu G, Meng J, Sun JL, Tao A, Tang W, Wang H, Wang X, Wei J, Shao X, Xiang L, Tsui SK, Zhang H, Yu Y, Zhao L, Huang Z, Gan H, Zhang J, Zheng X, Zheng P, Huang H, Hao C, Zhu R, Sun B. Chinese expert consensus on allergen component resolved diagnosis. Pediatr Allergy Immunol. 2024 Nov;35(11):e14272. doi: 10.1111/pai.14272.
PubMed 39503267Xu Q, Zhou Q, Chen J, Li T, Ma J, Du R, Su M, Li J, Xu M, Sun S, Ma J, Ramanathan M Jr, Zhang Z. The incidence of asthma attributable to temperature variability: An ecological study based on 1990-2019 GBD data. Sci Total Environ. 2023 Dec 15;904:166726. doi: 10.1016/j.scitotenv.2023.166726. Epub 2023 Sep 1.
PubMed 37659541Chan A, De Simoni A, Wileman V, Holliday L, Newby CJ, Chisari C, Ali S, Zhu N, Padakanti P, Pinprachanan V, Ting V, Griffiths CJ. Digital interventions to improve adherence to maintenance medication in asthma. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD013030. doi: 10.1002/14651858.CD013030.pub2.
PubMed 35691614Venkatesan P. 2023 GINA report for asthma. Lancet Respir Med. 2023 Jul;11(7):589. doi: 10.1016/S2213-2600(23)00230-8. Epub 2023 Jun 8. No abstract available.
PubMed 37302397Hao Y, Yang Y, Zhao H, Chen Y, Zuo T, Zhang Y, Yu H, Cui L, Song X. Multi-omics in Allergic Rhinitis: Mechanism Dissection and Precision Medicine. Clin Rev Allergy Immunol. 2025 Feb 18;68(1):19. doi: 10.1007/s12016-025-09028-3.
PubMed 39964644
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Registry Study Examining the Efficacy of Specific Immunotherapy Guided by Component-Resolved Diagnosis for Dust Mite Allergens in Chinese Pediatric Patients With Rhinitis and/or Asthma（EXPLORER STUDY）
- ClinicalTrials.gov ID
- NCT07452380
- Acronym / sponsor ID
- 2025-IRB-0386-P-01
- Conditions
- Allergic Rhinitis Due to House Dust Mite
- Keywords
- House dust mite, allergic rhinitis, Component-Resolved Diagnosis, Allergen Immunotherapy, subcutaneous immunotherapy, asthma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The Children's Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 5 Mar 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 is a Study to Understand How to Better Match Allergy Shots to a Child's Unique Mite Allergy Profile
- Why is this study being done? For many children, tiny house dust mites are a major cause of persistent allergies, leading to uncomfortable symptoms like a stuffy nose, sneezing, and even asthma. A common long-term treatment is allergy shots, also known as allergen immunotherapy (AIT). These shots work like a vaccine, slowly training the body's immune system to stop overreacting to mites. However, not every child responds to this treatment in the same way. The investigators now know that children can be allergic to different parts of the dust mite. While most treatments focus on the most common parts (called "major allergens"), some children are allergic to other, less common parts (called "intermediate or minor allergens"). The EXPLORER study wants to find out if a child's unique allergy profile-meaning which specific mite proteins they are allergic to-affects how well they respond to allergy shots. Our goal is to move away from a "one-size-fits-all" approach and toward more personalized care for children with dust mite allergies.
- Who is this study for? The investigators are looking for children and teenagers (ages 5 to 18) in China who have a confirmed dust mite allergy and are planning to start allergy shots.
- What will happen during the study? This is an "observational" study, which means the investigators will simply observe and track the progress of children who are already receiving a standard, approved allergy shot treatment as part of their regular medical care. The investigators won't be testing a new drug. Here's what participation involves: A Detailed Allergy Test: At the beginning, participants will have a special blood test. This test will look for allergies to nine different specific parts of the dust mite, giving us a very detailed map of their allergy. Grouping: Based on the results of this test, participants will be placed into different groups according to their specific allergy patterns. Tracking Progress: The investigators will follow their treatment journey for three years. The investigators will collect information at regular check-ups (at 0, 3, 6, 12, 24, and 36 months) on: How well their symptoms are controlled. How much allergy medication they need. Their overall quality of life. Any side effects from the shots. Annual Blood Tests: Once a year, the investigators will repeat the detailed blood test to see how their immune system is changing in response to the treatment.
- What do the investigators hope to learn? The investigators have a main theory, or hypothesis: Children who are allergic to many different parts of the dust mite (including the minor ones) will show greater improvement from the allergy shots, compared to children who are only allergic to the most common parts. By studying a large group of 1,000 children, the investigators hope to provide clear evidence that can help doctors choose the right treatment for the right child. This will help fill a current gap in medical guidelines and bring us closer to truly personalized treatment for pediatric allergies.
- Why is this study important? This is the first large-scale study of its kind in a real-world setting. The results could change how doctors diagnose and treat dust mite allergies in children. Instead of just knowing a child is allergic to mites, the investigators will be able to see the full picture of how they are allergic. This knowledge will help ensure that every child receives the treatment that gives them the best chance for long-term relief.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| major allergens group | – | –The group containing only major allergen components detected by Component-Resolved Diagnosis |
| intermediate/minor allergens group | – | –The group containing intermediate/minor allergens with or without major components. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This study plans to recruit participants from multiple research centers across China between November 2025 and November 2028. The target population is children aged 5 to 18 years who have been confirmed as having dust mite allergy through allergen testing and are scheduled to receive subcutaneous specific immunotherapy with a dust mite dual-allergen preparation.
Key inclusion criteria (2 listed)
- -(1) Age: 5 years ≤ age < 18 years; (2) 1) Allergic rhinitis caused by Dermatophagoides pteronyssinus and/or Dermatophagoides farinae; 2) Or serum specific IgE ≥ 0.70 (kU/L) (for D. pteronyssinus and/or D. farinae); (3) Children meeting criteria (2) must undergo allergen component testing; (4) If accompanied by bronchial asthma, asthma must be diagnosed according to the Guidelines for the Diagnosis and Prevention of Childhood Bronchial Asthma (2025 edition) and the patient's asthma symptoms must be confirmed as well-controlled.
- Receiving treatment with dual-mite (Dermatophagoides pteronyssinus and farinae) subcutaneous immunotherapy (SCIT).
Key exclusion criteria (1 listed)
- (1) Participants and/or their parents/legal guardians are judged by the investigator to be unable to fully understand the study requirements, or to adhere to long-term treatment and identify adverse reactions (including but not limited to conditions such as cognitive impairment or mental illness); (2) Children with severe or uncontrolled asthma (FEV1 < 70% of predicted value) or with irreversible airflow obstruction; (3) Children using beta-blockers or angiotensin-converting enzyme inhibitors (ACEI); (4) Children with severe autoimmune diseases or immunodeficiencies, including AIDS, inflammatory bowel disease, etc., as well as those currently using immunosuppressants; (5) Children with severe cardiovascular diseases or malignant tumors; (6) Children with incomplete clinical data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Changes of CSMS
Time frame: evaluated at months 3, 6, 12, 24, and 36
the change from baseline in Combined Symptom and Medication Scores (CSMS). CSMS includes a symptom score and a medication score. The minimum value for the symptom score is 0 and the maximum is 3. The minimum value for the medication score is 0 and the maximum is 3. The combined score is the sum of these two scores, with a higher score indicating more severe symptoms.
2 secondary outcomes
serological markers
Time frame: at years 1, 2, and 3
Visual Analog Scale (VAS) scores
Time frame: evaluated at months 3, 6, 12, 24, and 36
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 9 Mar 2026.
- Background: PubMed 39678704Schuster A, Caimmi D, Nolte H, Novakova S, Mikler J, Foss-Skiftesvik MH, Osterdal AS, Emeryk A, Gagnon R, Pfaar O. Efficacy and safety of SQ house dust mite sublingual immunotherapy-tablet (12 SQ-HDM) in children with allergic rhinitis/rhinoconjunctivitis with or without asthma (MT-12): a randomised, double-blind, placebo-controlled, phase III trial. Lancet Reg Health Eur. 2024 Nov 26;48:101136. doi: 10.1016/j.lanepe.2024.101136. eCollection 2025 Jan.
- Background: PubMed 32298697Rodriguez-Dominguez A, Berings M, Rohrbach A, Huang HJ, Curin M, Gevaert P, Matricardi PM, Valenta R, Vrtala S. Molecular profiling of allergen-specific antibody responses may enhance success of specific immunotherapy. J Allergy Clin Immunol. 2020 Nov;146(5):1097-1108. doi: 10.1016/j.jaci.2020.03.029. Epub 2020 Apr 13.
- Background: PubMed 36519672Gan H, Luo W, Huang Z, Zhang T, Hou X, Chen Y, Zhu Z, Sun B. House dust mite components sensitization profile in China, a multi-centre study. Clin Exp Allergy. 2023 Feb;53(2):226-229. doi: 10.1111/cea.14255. Epub 2022 Dec 15. No abstract available.
- Background: PubMed 30445063Chen KW, Zieglmayer P, Zieglmayer R, Lemell P, Horak F, Bunu CP, Valenta R, Vrtala S. Selection of house dust mite-allergic patients by molecular diagnosis may enhance success of specific immunotherapy. J Allergy Clin Immunol. 2019 Mar;143(3):1248-1252.e12. doi: 10.1016/j.jaci.2018.10.048. Epub 2018 Nov 14. No abstract available.
- Background: PubMed 39503267Luo W, Chen H, Cheng L, Cui Y, Guo Y, Gao Z, Guan K, Han K, Hong H, Ji K, Li J, Liu G, Meng J, Sun JL, Tao A, Tang W, Wang H, Wang X, Wei J, Shao X, Xiang L, Tsui SK, Zhang H, Yu Y, Zhao L, Huang Z, Gan H, Zhang J, Zheng X, Zheng P, Huang H, Hao C, Zhu R, Sun B. Chinese expert consensus on allergen component resolved diagnosis. Pediatr Allergy Immunol. 2024 Nov;35(11):e14272. doi: 10.1111/pai.14272.
- Background: PubMed 37659541Xu Q, Zhou Q, Chen J, Li T, Ma J, Du R, Su M, Li J, Xu M, Sun S, Ma J, Ramanathan M Jr, Zhang Z. The incidence of asthma attributable to temperature variability: An ecological study based on 1990-2019 GBD data. Sci Total Environ. 2023 Dec 15;904:166726. doi: 10.1016/j.scitotenv.2023.166726. Epub 2023 Sep 1.
- Background: PubMed 35691614Chan A, De Simoni A, Wileman V, Holliday L, Newby CJ, Chisari C, Ali S, Zhu N, Padakanti P, Pinprachanan V, Ting V, Griffiths CJ. Digital interventions to improve adherence to maintenance medication in asthma. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD013030. doi: 10.1002/14651858.CD013030.pub2.
- Background: PubMed 37302397Venkatesan P. 2023 GINA report for asthma. Lancet Respir Med. 2023 Jul;11(7):589. doi: 10.1016/S2213-2600(23)00230-8. Epub 2023 Jun 8. No abstract available.
- Background: PubMed 39964644Hao Y, Yang Y, Zhao H, Chen Y, Zuo T, Zhang Y, Yu H, Cui L, Song X. Multi-omics in Allergic Rhinitis: Mechanism Dissection and Precision Medicine. Clin Rev Allergy Immunol. 2025 Feb 18;68(1):19. doi: 10.1007/s12016-025-09028-3.
- Individual participant dataSharing planned: No. In the EDC system, only the data entry personnel at the principal investigator's site and sub-centers are permitted to input data, and only the data monitoring personnel are permitted to view it.
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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.
Lanfang Tang, PhD study director
The Children's Hospital of Zhejiang University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinitis Due to House Dust Mite, run by The Children's Hospital of Zhejiang University School of Medicine 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 2 inclusion and 1 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 9 Mar 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?
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 Yujia Xiao, PhD (86+13397813805, 6195007@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Changes of CSMS (time frame: evaluated at months 3, 6, 12, 24, and 36). 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 NCT07452380, which also lists 9 linked publications.
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 9 Mar 2026.