Allergic RhinitisNCT06173882
Moxibustion Reduces Symptoms and Improves Quality of Life in Patients With Allergic Rhinitis
A study testing Ordinary moxibustion volume group, First group of heavy moxibustion and Second groups of heavy moxibustion in people with Allergic Rhinitis, run by Henan University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The objective of this randomized controlled clinical trial is to compare the therapeutic effect of moxibustion on allergic rhinitis. The main questions it aims to answer are: Based on randomized controlled trials, verify the effectiveness of moxibustion in treating allergic rhinitis Based on a real-time monitoring… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Ordinary moxibustion volume group, First group of heavy moxibustion and Second groups of heavy moxibustion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 1 Aug 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those who meet the diagnostic criteria of Chinese and Western medicine for AR;
- Age range from 18 to 75 years old, regardless of gender;
- Patients and their families are informed and agree to the study.
Who cannot join
- Those who are undergoing other traditional Chinese medicine external treatment methods;
- Those who have taken traditional Chinese medicine recently or during treatment;
- Individuals who are allergic to heavy moxibustion smoke and dust;
- Individuals with concomitant bronchial asthma or other respiratory system diseases;
- Patients with severe skin diseases or ulcers in the local area where moxibustion is applied;
- Pregnant and lactating patients;
- Patients with severe diseases of important organs such as the heart, liver, lungs, and kidneys;
- Those who are unable to receive treatment according to regulations due to inconvenience in work, study, transportation, or personal activities
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou
Yang Xie, MD, 0371-66248624, xieyanghn@163.com
About this study
Official title: The Therapeutic Effect and Standardization of Moxibustion in the Treatment of Allergic Rhinitis
The objective of this randomized controlled clinical trial is to compare the therapeutic effect of moxibustion on allergic rhinitis. The main questions it aims to answer are:
Based on randomized controlled trials, verify the effectiveness of moxibustion in treating allergic rhinitis Based on a real-time monitoring system for human surface temperature, discuss the differences in therapeutic effects of different moxibustion doses on allergic rhinitis
Read the detailed description
Allergic rhinitis has a high incidence and is difficult to cure, seriously affecting the quality of life of patients Compare the effects of different moxibustion durations on the clinical efficacy and body surface temperature of patients with allergic rhinitis, and preliminarily explore the impact of different moxibustion doses on the efficacy of heavy moxibustion treatment for allergic rhinitis, providing evidence-based basis for clinical practice.
- Conditions
- Allergic Rhinitis
- Being tested
- Ordinary moxibustion volume group, First group of heavy moxibustion, Second groups of heavy moxibustion
- Keywords
- allergic rhinitis, moxibustion, body surface temperature
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ordinary moxibustion volume groupBehavioural
Moxibustion for 10 minutes per acupoint
First group of heavy moxibustionBehavioural
Moxibustion for 20 minutes per acupoint
Second groups of heavy moxibustionBehavioural
Moxibustion for 30 minutes per acupoint
| Study group | Role | What they receive |
|---|---|---|
| Ordinary moxibustion volume group | Placebo comparator | Not described Receives: Behavioral: Ordinary moxibustion volume group |
| First group of heavy moxibustion | Experimental | Not described Receives: Behavioral: First group of heavy moxibustion |
| Second groups of heavy moxibustion | Experimental | Not described Receives: Behavioral: Second groups of heavy moxibustion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rhinitis VAS Visual Analog Scale（AR-VAS）
VAS will be used to evaluate the relief of rhinitis symptoms, with a total score of 0-10. The higher the score, the more severe the symptoms will be
Measured: Change from baseline VAS scores at week 0(before treatment)，4 and 12.
Total nasal symptom scores（TNSS）
The main symptoms of allergic rhinitis, the higher the score, the worse the condition
Measured: Change from baseline TNSS scores at week 0(before treatment)，4 and 12.
Secondary outcomes (3)
Total non nasal symptom scores（TNNSS）
The nasal accompanying symptoms of allergic rhinitis, qualitative evaluation of the severity of the disease, with some indicating severity and none indicating milder severity
Measured: Change from baseline TNNSS scores at week0(before treatment)，4 and 12.
Rhino-conjunctivitis Quality of Life Questionnaire （RQLQ）
RQLQ consists of 28 items, including daily life (1-3), sleep (4-6), non nasal eye symptoms (7-13), life problems (14-16), nasal symptoms (17-20), eye symptoms (21-24), and emotions (25-28). In the 7-point system, 1 point is the best and 7 points are the worst.
Measured: Change from baseline RQLQ scores at week0(before treatment)，4 and 12.
Detection of serum IgE and IL-33 levels
Immunoglobulin IgE and serum inflammatory cytokine IL-33 levels
Measured: Week0(before treatment), week 4（after treatment）.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start1 Aug 2022
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2025 (estimated)
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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yang Xie, MD, Study director, Henan University of Traditonal Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173882
- Sponsor's protocol ID
- TCM for AR
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Therapeutic Effect and Standardization of Moxibustion in the Treatment of Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT06173882
- Acronym / sponsor ID
- TCM for AR
- Conditions
- Allergic Rhinitis
- Keywords
- allergic rhinitis, moxibustion, body surface temperature
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 18 Dec 2023 (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 objective of this randomized controlled clinical trial is to compare the therapeutic effect of moxibustion on allergic rhinitis. The main questions it aims to answer are:
Based on randomized controlled trials, verify the effectiveness of moxibustion in treating allergic rhinitis Based on a real-time monitoring system for human surface temperature, discuss the differences in therapeutic effects of different moxibustion doses on allergic rhinitis
Detailed description
Allergic rhinitis has a high incidence and is difficult to cure, seriously affecting the quality of life of patients Compare the effects of different moxibustion durations on the clinical efficacy and body surface temperature of patients with allergic rhinitis, and preliminarily explore the impact of different moxibustion doses on the efficacy of heavy moxibustion treatment for allergic rhinitis, providing evidence-based basis for clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ordinary moxibustion volume group | Placebo comparator | Behavioral: Ordinary moxibustion volume group |
| First group of heavy moxibustion | Experimental | Behavioral: First group of heavy moxibustion |
| Second groups of heavy moxibustion | Experimental | Behavioral: Second groups of heavy moxibustion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Those who meet the diagnostic criteria of Chinese and Western medicine for AR;
- Age range from 18 to 75 years old, regardless of gender;
- Patients and their families are informed and agree to the study.
Key exclusion criteria (8 listed)
- Those who are undergoing other traditional Chinese medicine external treatment methods;
- Those who have taken traditional Chinese medicine recently or during treatment;
- Individuals who are allergic to heavy moxibustion smoke and dust;
- Individuals with concomitant bronchial asthma or other respiratory system diseases;
- Patients with severe skin diseases or ulcers in the local area where moxibustion is applied;
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 |
|---|---|---|
| Ordinary moxibustion volume groupMoxibustion for 10 minutes per acupoint | Behavioural | Ordinary moxibustion volume group |
| First group of heavy moxibustionMoxibustion for 20 minutes per acupoint | Behavioural | First group of heavy moxibustion |
| Second groups of heavy moxibustionMoxibustion for 30 minutes per acupoint | Behavioural | Second groups of heavy moxibustion |
Primary outcome
Rhinitis VAS Visual Analog Scale（AR-VAS）
Time frame: Change from baseline VAS scores at week 0(before treatment)，4 and 12.
VAS will be used to evaluate the relief of rhinitis symptoms, with a total score of 0-10. The higher the score, the more severe the symptoms will be
Total nasal symptom scores（TNSS）
Time frame: Change from baseline TNSS scores at week 0(before treatment)，4 and 12.
The main symptoms of allergic rhinitis, the higher the score, the worse the condition
3 secondary outcomes
Total non nasal symptom scores（TNNSS）
Time frame: Change from baseline TNNSS scores at week0(before treatment)，4 and 12.
Rhino-conjunctivitis Quality of Life Questionnaire （RQLQ）
Time frame: Change from baseline RQLQ scores at week0(before treatment)，4 and 12.
Detection of serum IgE and IL-33 levels
Time frame: Week0(before treatment), week 4（after treatment）.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
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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.
Yang Xie, MD study director
Henan University of Traditonal Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ordinary moxibustion volume group, First group of heavy moxibustion and Second groups of heavy moxibustion in people with Allergic Rhinitis, run by Henan University of Traditional Chinese 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 3 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: status not confirmed, as of the sponsor's last update on 18 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Xie, MD (0371-66248624, xieyanghn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rhinitis VAS Visual Analog Scale（AR-VAS） (time frame: Change from baseline VAS scores at week 0(before treatment)，4 and 12.). The study lists 2 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 18 Dec 2023.