Enhancing Treatment Outcomes for Patients With Allergic RhinitisNCT06998472
Evaluation of Pediatric Massage in the Treatment of Allergic Rhinitis in Children
A study testing Tuina and Maintain the original treatment approach in people with Enhancing Treatment Outcomes for Patients With Allergic Rhinitis, run by Taichung Tzu Chi Hospital at 1 site in Taiwan.
Trial summary
The purpose of this clinical trial is to evaluate the effectiveness of pediatric tuina (traditional Chinese pediatric massage therapy) in children with allergic rhinitis, aiming to provide an effective, non-invasive treatment option. This study will last for 12 weeks. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Enhancing Treatment Outcomes for Patients With Allergic Rhinitis
- What is being tested?
- Tuina and Maintain the original treatment approach
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Jul 2023to 28 Mar 2025
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- (1) no skin surface damage (2) no mental or cognitive impairments, with clear consciousness, and (3) a patient who has been medically diagnosed with allergic rhinitis.
Who cannot join
- (1) the presence of inflammatory wounds or ulcers on the skin surface; (2) pregnant or breastfeeding women; (3) individuals with congenital genetic diseases, heart disease, tumors, or chronic illnesses.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taichung Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Taichung, Taiwan, 427
About this study
The purpose of this clinical trial is to evaluate the effectiveness of pediatric tuina (traditional Chinese pediatric massage therapy) in children with allergic rhinitis, aiming to provide an effective, non-invasive treatment option. This study will last for 12 weeks. If you meet the eligibility criteria, agree to participate, and sign the informed consent form, you will be randomly assigned to one of two groups: the treatment group or the control group. Random assignment is similar to a dice roll, giving you a 50% chance of being placed in either group.
Participants in the treatment group will receive pediatric tuina in combination with standard Western medical treatment. Participants in the control group will receive only the standard Western medical treatment. At the beginning of the trial, a pediatrician will collect your medical history and basic information. In addition, a traditional Chinese medicine (TCM) practitioner will conduct a meridian energy assessment and perform a TCM diagnostic evaluation (including the Four Diagnostic Methods and Heat Syndrome Assessment), which will take approximately 20 minutes. A research assistant will help administer a 22-item nasal symptom questionnaire and an allergic rhinitis quality of life questionnaire, which will take about 10 minutes. During the 12-week treatment period, follow-up assessments will be conducted twice-once at week 4 and again at the end of the treatment period in week 12. Both follow-ups will include the meridian energy test, TCM diagnostic evaluation, and allergic rhinitis questionnaires. Throughout the 12-week trial, participants in the treatment group will receive pediatric tuina therapy once a week. Each session will last approximately 15 minutes and will be conducted by a licensed TCM practitioner on a treatment table in the clinic.
Read more
The pediatric tuina treatment in this study will primarily focus on regulating the Bladder Meridian (dorsal fascia), Stomach Meridian (abdominal fascia), and the Lower Jiao (pelvic region). The techniques used are based on the Formless Qi Manipulation Tuina method developed by Master Chen Ming-Tang.
The treatment sequence begins with the "Swimming Belt to Search for Food" technique, which is used to relax the upper and middle segments of the spine, release tension in the paraspinal muscles, and correct spinal distortions. This is followed by the "Scooping Water to Splash the Face" technique to loosen the lower spine and pelvic region, helping to restore balance and alignment in the pelvis. Finally, the "Master Pulling the Spinning Top" technique is used to regulate the tibia, thereby improving gait and correcting imbalances in the pelvis and spine caused by improper walking posture.
The goal of this tuina treatment is to restore the body's structural balance. By adjusting muscles, tendons, ligaments, and fascia back to their proper alignment, qi and blood can circulate smoothly throughout the body. This supports the TCM principle that "when vital qi is strong, pathogenic factors cannot invade," thereby promoting a healthy internal environment.
The Meridian Energy Analysis Device (MEAD) is a computerized, non-invasive diagnostic tool commonly used in traditional Chinese medicine. It measures the activity level of the body's meridians and helps provide more accurate diagnostic insight from a TCM perspective. During the test, the practitioner will ask you to hold a testing probe while another probe touches 24 specific acupuncture points around the wrists and ankles. The assessment takes approximately 20 minutes to complete.
- Being tested
- Tuina, Maintain the original treatment approach
- Keywords
- Tuina
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TuinaOther
According to traditional Chinese medicine (TCM), children's physiological characteristics include immature and delicate internal organs, as well as underdeveloped qi and physical form. Pathologically, their organ systems are described as light and responsive, meaning they react quickly to both internal and external stimuli. Therefore, pediatric tuina must prioritize gentleness in technique. The applied pressure should not exceed 0.3 kilograms, and the depth of skin indentation should not go beyond 0.3 centimeters.
Maintain the original treatment approachOther
Maintain the original treatment approach
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | Maintain the original treatment approach Receives: Other: Maintain the original treatment approach |
| tuina group | Experimental | Tuina therapy is administered once a week, each session lasting 15 minutes, for a duration of three months Receives: Other: Tuina |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
The evaluation of allergic rhinitis symptom efficacy is measured using the RQLQ. The RQLQ consists of 28 questions across seven domains: activity limitations, nose symptoms, eye symptoms, non-nose/eye symptoms, practical problems, sleep problems, and emotional function Additionally, there are three patient-specific activity-related questions, allowing patients to select the three activities they most frequently engage in that are restricted by their allergic rhinitis symptoms. Subjects respond to each question using a 7-point scale (0 = not impaired at all, 6 = severely impaired). The overall RQLQ score is calculated as the mean of all 28 responses, while the domain scores represent the average score of items within each respective domain.
Measured: This study will last for 12 weeks. During this 12-week trial period, participants will receive pediatric Tuina therapy once a week. A follow-up assessment will be conducted at Week 16. Eligibility
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start7 Jul 2023
- Primary completion2 Dec 2024
- Study completion28 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enhancing Treatment Outcomes for Patients With 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
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Tzu Chi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu-Yu Yang, Taichung Tzu Chi Hospital
- Investigators
- Shu-Yu Yang, Principal investigator, Taichung Tzu Chi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998472
- Sponsor's protocol ID
- REC 111-31
- Status last verified
- May 2025
- First submitted
- 22 May 2025
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pediatric Massage in the Treatment of Allergic Rhinitis in Children
- ClinicalTrials.gov ID
- NCT06998472
- Acronym / sponsor ID
- REC 111-31
- Keywords
- Tuina
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Taichung Tzu Chi HospitalUniversity, hospital or other
- Study start
- 7 Jul 2023 (actual)
- Primary completion
- 2 Dec 2024 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 31 May 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.
The purpose of this clinical trial is to evaluate the effectiveness of pediatric tuina (traditional Chinese pediatric massage therapy) in children with allergic rhinitis, aiming to provide an effective, non-invasive treatment option. This study will last for 12 weeks. If you meet the eligibility criteria, agree to participate, and sign the informed consent form, you will be randomly assigned to one of two groups: the treatment group or the control group. Random assignment is similar to a dice roll, giving you a 50% chance of being placed in either group.
Participants in the treatment group will receive pediatric tuina in combination with standard Western medical treatment. Participants in the control group will receive only the standard Western medical treatment. At the beginning of the trial, a pediatrician will collect your medical history and basic information. In addition, a traditional Chinese medicine (TCM) practitioner will conduct a meridian energy assessment and perform a TCM diagnostic evaluation (including the Four Diagnostic Methods and Heat Syndrome Assessment), which will take approximately 20 minutes. A research assistant will help administer a 22-item nasal symptom questionnaire and an allergic rhinitis quality of life questionnaire, which will take about 10 minutes. During the 12-week treatment period, follow-up assessments will be conducted twice-once at week 4 and again at the end of the treatment period in week 12. Both follow-ups will include the meridian energy test, TCM diagnostic evaluation, and allergic rhinitis questionnaires. Throughout the 12-week trial, participants in the treatment group will receive pediatric tuina therapy once a week. Each session will last approximately 15 minutes and will be conducted by a licensed TCM practitioner on a treatment table in the clinic.
The pediatric tuina treatment in this study will primarily focus on regulating the Bladder Meridian (dorsal fascia), Stomach Meridian (abdominal fascia), and the Lower Jiao (pelvic region). The techniques used are based on the Formless Qi Manipulation Tuina method developed by Master Chen Ming-Tang.
The treatment sequence begins with the "Swimming Belt to Search for Food" technique, which is used to relax the upper and middle segments of the spine, release tension in the paraspinal muscles, and correct spinal distortions. This is followed by the "Scooping Water to Splash the Face" technique to loosen the lower spine and pelvic region, helping to restore balance and alignment in the pelvis. Finally, the "Master Pulling the Spinning Top" technique is used to regulate the tibia, thereby improving gait and correcting imbalances in the pelvis and spine caused by improper walking posture.
The goal of this tuina treatment is to restore the body's structural balance. By adjusting muscles, tendons, ligaments, and fascia back to their proper alignment, qi and blood can circulate smoothly throughout the body. This supports the TCM principle that "when vital qi is strong, pathogenic factors cannot invade," thereby promoting a healthy internal environment.
The Meridian Energy Analysis Device (MEAD) is a computerized, non-invasive diagnostic tool commonly used in traditional Chinese medicine. It measures the activity level of the body's meridians and helps provide more accurate diagnostic insight from a TCM perspective. During the test, the practitioner will ask you to hold a testing probe while another probe touches 24 specific acupuncture points around the wrists and ankles. The assessment takes approximately 20 minutes to complete.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Other: Maintain the original treatment approachMaintain the original treatment approach |
| tuina group | Experimental | Other: TuinaTuina therapy is administered once a week, each session lasting 15 minutes, for a duration of three months |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- (1) no skin surface damage (2) no mental or cognitive impairments, with clear consciousness, and (3) a patient who has been medically diagnosed with allergic rhinitis.
Key exclusion criteria (1 listed)
- (1) the presence of inflammatory wounds or ulcers on the skin surface; (2) pregnant or breastfeeding women; (3) individuals with congenital genetic diseases, heart disease, tumors, or chronic illnesses.
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 |
|---|---|---|
| TuinaAccording to traditional Chinese medicine (TCM), children's physiological characteristics include immature and delicate internal organs, as well as underdeveloped qi and physical form. Pathologically, their organ systems are described as light and responsive, meaning they react quickly to both internal and external stimuli. Therefore, pediatric tuina must prioritize gentleness in technique. The applied pressure should not exceed 0.3 kilograms, and the depth of skin indentation should not go beyond 0.3 centimeters. | Other | tuina group |
| Maintain the original treatment approachMaintain the original treatment approach | Other | control group |
Primary outcome
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
Time frame: This study will last for 12 weeks. During this 12-week trial period, participants will receive pediatric Tuina therapy once a week. A follow-up assessment will be conducted at Week 16. Eligibility
The evaluation of allergic rhinitis symptom efficacy is measured using the RQLQ. The RQLQ consists of 28 questions across seven domains: activity limitations, nose symptoms, eye symptoms, non-nose/eye symptoms, practical problems, sleep problems, and emotional function Additionally, there are three patient-specific activity-related questions, allowing patients to select the three activities they most frequently engage in that are restricted by their allergic rhinitis symptoms. Subjects respond to each question using a 7-point scale (0 = not impaired at all, 6 = severely impaired). The overall RQLQ score is calculated as the mean of all 28 responses, while the domain scores represent the average score of items within each respective domain.
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 31 May 2025.
- Individual participant dataSharing planned: Yes
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.
Shu-Yu Yang principal investigator
Taichung Tzu Chi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tuina and Maintain the original treatment approach in people with Enhancing Treatment Outcomes for Patients With Allergic Rhinitis, run by Taichung Tzu Chi Hospital at 1 site in Taiwan.
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 1 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: finished, as of the sponsor's last update on 31 May 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 Taiwan. 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?
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?
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) (time frame: This study will last for 12 weeks. During this 12-week trial period, participants will receive pediatric Tuina therapy once a week. A follow-up assessment will be conducted at Week 16. Eligibility). 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 31 May 2025.