Allergic RhinitisPhase 2NCT04976023
The Effects of Using Yupingfeng Powder with Variation for the Treatment of Allergic Rhinitis
A Phase 2 study testing Yupingfeng Powder granules in people with Allergic Rhinitis, run by Prof. Lin Zhixiu at 1 site in Hong Kong.
Trial summary
Allergic rhinitis (AR) is an IgE mediated chronic inflammatory disease of the upper airways characterized by symptoms of sneezing, rhinorrhea, nasal itching, and nasal obstruction . Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Yupingfeng Powder granules
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteHong Kong
- Study dates
- 12 Apr 2022to 20 Jun 2023
- Phase
- Phase 2
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age d above 5;
- Subjects with deficiency of lung and spleen Qi;
- At least 2 or more allergic symptoms rhinorrhea , sneezing , nasal obstruction and nasal itching for a cumulative period greater than 1 hour per day. These symptoms may be accompanied by itchy and red eyes and tears;
- Positive srum IgE test;
- Voluntary written consent.
Who cannot join
- Known chronic disease such as asthma, rhinosinusitis, nasal polyposis;
- Known severe medical conditions, such as cardiovascular, liver or renal dysfunction, diabetes mellitus, cancers, cerebrovascular diseases, blood system diseases;
- Concomitant steroid, nonsteroidal anti inflammatory drugs (NSAIDs), anticoagulant, and immunotherapy within past month;
- Impaired hematological profile and liver / renal function;
- Known alcohol and / or drug abuse;
- Known allergic history to any Chinese herbal medicines;
- Subjects who are pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Using Yupingfeng Powder with Variation for the Treatment of Allergic Rhinitis(AR):a Randomized Controlled Trial
Allergic rhinitis (AR) is an IgE mediated chronic inflammatory disease of the upper airways characterized by symptoms of sneezing, rhinorrhea, nasal itching, and nasal obstruction . However, not only this disease is difficult to cure, but also its relapse rate is high, therefore exerting a certain impact on their daily life, work and study. Nowadays, the main treatment for allergic rhinitis is the use of western medicine, such as steroids and antihistamines. However, many clinical studies have found that the curative effect of western medicine is often not ideal.
Allergic rhinitis belongs to the category of "Rhinitis" in Chinese medicine. From the perspective of Chinese medicine, this disease is resulted from the deficiency of Qi and Yang Qi in the lungs, spleen and kidneys. Therefore, according to Chinese medicine theory, tonifying lung and spleen qi is the treatment principle for AR patients. Among different Chinese herbal formulae for AR, Yupingfeng san is commonly used for allergic diseases and in AR patients, due to its warm nature and able to improve the functions of the lungs and spleen. Yupingfeng san can improve symptoms and quality of life, as well as decrease the levels of interleukin and IgE in AR patients. This study will use Yupingfeng Powder with variation to evaluate its effectiveness and safety in treating AR. Hence, this study would be able to provide evidence on the efficacy and safety of Yupingfeng Powder with variation for AR.
Read the detailed description
Rhinitis is broadly defined as inflammation of the nasal mucosa. It is a common disorder that affects up to 40% of the population. Allergic rhinitis (AR) is the most common type of chronic rhinitis, affecting 10-20% of the population, and evidence suggests that the prevalence of the disorder is increasing. AR is a very common clinical disease that can occur at any age. Severe allergic rhinitis has been associated with significant impairments in quality of life, sleep and work performance.
Allergic rhinitis is a complex immune and inflammatory disease. Its pathogenesis has not yet been fully known, and there is no clear way to cure. It is an IgE-mediated chronic inflammatory disease of the upper airways characterized by symptoms of sneezing, rhinorrhea, nasal itching, and nasal obstruction, and cytokines such as IL-17 and IL-10 play an essential role in mediating allergic inflammation. Nowadays, the main treatment for allergic rhinitis is the use of western medicine, such as steroids and antihistamines. However, many clinical studies have found that the curative effect of western medicine is often not ideal.
Chinese herbal medicine (CHM) is a well tolerated choice for AR patients seeking complementary and alternative therapies to reduce AR symptoms. In recent years, studies have found that Yupingfeng Powder not only has few side effects (feeling of abdominal distension or increased in acne are reported), it can al so increase anti allergic ability and improve body's resistance, thus showing the advantages of oral Chinese medicine in the treatment of AR. Accordingly, CHM may influence the gastrointestinal system, including the intestinal mucosa and gut microbiota, the latter of which is essential for health and closely linked to diseases. A few systematic reviews and studies indicate that certain probiotics are beneficial for patients with AR.
In this study, fifty-eight eligible subjects will be recruited from Paediatric out-patient clinic and community, and randomly assigned to receive orally Yupingfeng Powder with variation or placebo twice a day for 8 weeks, with follow-up for another 8 weeks after stopping the treatment to observe the duration of efficacy and to explore the mechanism of Yupingfeng Powder in treating AR with respect to the immune response and gut microbiota.
- Conditions
- Allergic Rhinitis
- Being tested
- Yupingfeng Powder granules, Placebo
- Keywords
- Allergic Rhinitis, Yupingfeng Powder variation
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yupingfeng Powder granulesDrug
Also called Yupingfeng Powder with variation
14.5 5 g twice daily for 8 weeks
PlaceboOther
Also called Placebo granules
14.5 5 g twice daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Active Arm | Active comparator | 14.55g of Yupingfeng Powder granules twice daily for 8 weeks Receives: Drug: Yupingfeng Powder granules |
| Placebo Arm | Placebo comparator | 14.55g of placebo granules twice daily for 8 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the Total Nasal Symptom Score (TNSS)
The TNSS evaluates 4 nasal symptoms ( rhinorrhea, sneezing, nasal obstruction and nasal itching) which will be self assessed by subjects using a four point scale, with low scores indicating less severe nasal symptoms
Measured: Week 8
The changes in quality of life by using The changes in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
The lower the score the higher the quality of life
Measured: week 8
Secondary outcomes (8)
The change in the Total Nasal Symptom Score (TNSS)
The TNSS evaluates 4 nasal symptoms ( rhinorrhea, sneezing, nasal obstruction and nasal itching) which will be self assessed by subjects using a four point scale, with low scores indicating less severe nasal symptoms
Measured: week 4, week 12 and week 16
The changes in frequency of AR episodes and their severity on visual analog scale (VAS)
The VAS ranges from 0 (nasal symptom free) to 10 (nasal symptom extremely bothersome) to assess the severity of nasal symptom disturbance
Measured: week 4, week 8, week 12 and week 16
The changes in quality of life by using The changes in the Paediatric Allergic Disease Quality of Life Questionnaire (PADQLQ)
The lower the score the higher the quality of life
Measured: week 4, week 8, week 12 and week 16
The changes in quality of life by using The changes in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
The lower the score the higher the quality of life
Measured: week 4, week 12 and week 16
The changes in the serum levels of specific IgE
The serum levels of cytokines and IgE will be tested. The higher the value, the more severity of the symptoms.
Measured: week 8 and week 12
The changes in the serum levels of cytokines (IL-10 and IL-17)
Serum responses will correlate with the nasal symptoms scores.
Measured: week 8 and week 12
The changes in the gut microbiota composition in stools
The composition of gut microbiota will be tested to observe the influence of Chinese. Gut microbiome compositions will be characterised by shotgun sequencing total DNA extracted from stools.
Measured: week 8
Adverse events related to study treatment
All adverse events that are related to the study treatment will be captured for analysis.
Measured: During study for 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start12 Apr 2022
- Primary completion20 Jun 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Lin Zhixiu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Lin Zhixiu, Chinese University of Hong Kong
- Investigators
- Zhixiu Lin, PhD, Principal investigator, Hong Kong Institute of Integrative Medicine, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976023
- Sponsor's protocol ID
- A.Rhinitis study
- Status last verified
- Nov 2024
- First submitted
- 10 Jun 2021
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin ZX, Ho TM, Xian YF, Chan KL, Xu QQ, Lo CW, Wu JCY, Hon KL, Leung SB, Chia CP, Sum CH, Chow TY, Cheong PK, Ching JYL, Zhang H, Leung KC, Lin WL. Exploring the efficacy and safety of Yu-Ping-Feng powder with variation against allergic rhinitis: a randomized, double-blind, placebo-controlled trial. Chin Med. 2025 May 26;20(1):70. doi: 10.1186/s13020-025-01120-2.
PubMed 40420199Cheong PK, Ho TM, Chan KL, Lo CW, Leung SB, Hon KL, Leung KC, Siu THC, Song TH, Zhang H, Ching JYL, Chow TY, Sum CH, Chia CP, Lin ZX. The efficacy and safety of Yupingfeng Powder with variation in the treatment of allergic rhinitis: Study protocol for a randomized, double-blind, placebo-controlled trial. Front Pharmacol. 2022 Dec 16;13:1058176. doi: 10.3389/fphar.2022.1058176. eCollection 2022.
PubMed 36588672
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Using Yupingfeng Powder with Variation for the Treatment of Allergic Rhinitis(AR):a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04976023
- Acronym / sponsor ID
- A.Rhinitis study
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic Rhinitis, Yupingfeng Powder variation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Prof. Lin ZhixiuUniversity, hospital or other
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 26 Jul 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 IgE mediated chronic inflammatory disease of the upper airways characterized by symptoms of sneezing, rhinorrhea, nasal itching, and nasal obstruction . However, not only this disease is difficult to cure, but also its relapse rate is high, therefore exerting a certain impact on their daily life, work and study. Nowadays, the main treatment for allergic rhinitis is the use of western medicine, such as steroids and antihistamines. However, many clinical studies have found that the curative effect of western medicine is often not ideal.
Allergic rhinitis belongs to the category of "Rhinitis" in Chinese medicine. From the perspective of Chinese medicine, this disease is resulted from the deficiency of Qi and Yang Qi in the lungs, spleen and kidneys. Therefore, according to Chinese medicine theory, tonifying lung and spleen qi is the treatment principle for AR patients. Among different Chinese herbal formulae for AR, Yupingfeng san is commonly used for allergic diseases and in AR patients, due to its warm nature and able to improve the functions of the lungs and spleen. Yupingfeng san can improve symptoms and quality of life, as well as decrease the levels of interleukin and IgE in AR patients. This study will use Yupingfeng Powder with variation to evaluate its effectiveness and safety in treating AR. Hence, this study would be able to provide evidence on the efficacy and safety of Yupingfeng Powder with variation for AR.
Detailed description
Rhinitis is broadly defined as inflammation of the nasal mucosa. It is a common disorder that affects up to 40% of the population. Allergic rhinitis (AR) is the most common type of chronic rhinitis, affecting 10-20% of the population, and evidence suggests that the prevalence of the disorder is increasing. AR is a very common clinical disease that can occur at any age. Severe allergic rhinitis has been associated with significant impairments in quality of life, sleep and work performance.
Allergic rhinitis is a complex immune and inflammatory disease. Its pathogenesis has not yet been fully known, and there is no clear way to cure. It is an IgE-mediated chronic inflammatory disease of the upper airways characterized by symptoms of sneezing, rhinorrhea, nasal itching, and nasal obstruction, and cytokines such as IL-17 and IL-10 play an essential role in mediating allergic inflammation. Nowadays, the main treatment for allergic rhinitis is the use of western medicine, such as steroids and antihistamines. However, many clinical studies have found that the curative effect of western medicine is often not ideal.
Chinese herbal medicine (CHM) is a well tolerated choice for AR patients seeking complementary and alternative therapies to reduce AR symptoms. In recent years, studies have found that Yupingfeng Powder not only has few side effects (feeling of abdominal distension or increased in acne are reported), it can al so increase anti allergic ability and improve body's resistance, thus showing the advantages of oral Chinese medicine in the treatment of AR. Accordingly, CHM may influence the gastrointestinal system, including the intestinal mucosa and gut microbiota, the latter of which is essential for health and closely linked to diseases. A few systematic reviews and studies indicate that certain probiotics are beneficial for patients with AR.
In this study, fifty-eight eligible subjects will be recruited from Paediatric out-patient clinic and community, and randomly assigned to receive orally Yupingfeng Powder with variation or placebo twice a day for 8 weeks, with follow-up for another 8 weeks after stopping the treatment to observe the duration of efficacy and to explore the mechanism of Yupingfeng Powder in treating AR with respect to the immune response and gut microbiota.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Arm | Active comparator | Drug: Yupingfeng Powder granules14.55g of Yupingfeng Powder granules twice daily for 8 weeks |
| Placebo Arm | Placebo comparator | Other: Placebo14.55g of placebo granules twice daily for 8 weeks |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age d above 5;
- Subjects with deficiency of lung and spleen Qi;
- At least 2 or more allergic symptoms rhinorrhea , sneezing , nasal obstruction and nasal itching for a cumulative period greater than 1 hour per day. These symptoms may be accompanied by itchy and red eyes and tears;
- Positive srum IgE test;
- Voluntary written consent.
Key exclusion criteria (7 listed)
- Known chronic disease such as asthma, rhinosinusitis, nasal polyposis;
- Known severe medical conditions, such as cardiovascular, liver or renal dysfunction, diabetes mellitus, cancers, cerebrovascular diseases, blood system diseases;
- Concomitant steroid, nonsteroidal anti inflammatory drugs (NSAIDs), anticoagulant, and immunotherapy within past month;
- Impaired hematological profile and liver / renal function;
- Known alcohol and / or drug abuse;
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 |
|---|---|---|
| Yupingfeng Powder granulesAlso: Yupingfeng Powder with variation14.5 5 g twice daily for 8 weeks | Drug | Active Arm |
| PlaceboAlso: Placebo granules14.5 5 g twice daily for 8 weeks | Other | Placebo Arm |
Primary outcome
The change in the Total Nasal Symptom Score (TNSS)
Time frame: Week 8
The TNSS evaluates 4 nasal symptoms ( rhinorrhea, sneezing, nasal obstruction and nasal itching) which will be self assessed by subjects using a four point scale, with low scores indicating less severe nasal symptoms
The changes in quality of life by using The changes in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
Time frame: week 8
The lower the score the higher the quality of life
8 secondary outcomes
The change in the Total Nasal Symptom Score (TNSS)
Time frame: week 4, week 12 and week 16
The changes in frequency of AR episodes and their severity on visual analog scale (VAS)
Time frame: week 4, week 8, week 12 and week 16
The changes in quality of life by using The changes in the Paediatric Allergic Disease Quality of Life Questionnaire (PADQLQ)
Time frame: week 4, week 8, week 12 and week 16
The changes in quality of life by using The changes in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
Time frame: week 4, week 12 and week 16
The changes in the serum levels of specific IgE
Time frame: week 8 and week 12
The changes in the serum levels of cytokines (IL-10 and IL-17)
Time frame: week 8 and week 12
The changes in the gut microbiota composition in stools
Time frame: week 8
Adverse events related to study treatment
Time frame: During study for 16 weeks
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 7 Nov 2024.
- Derived from this study: PubMed 40420199Lin ZX, Ho TM, Xian YF, Chan KL, Xu QQ, Lo CW, Wu JCY, Hon KL, Leung SB, Chia CP, Sum CH, Chow TY, Cheong PK, Ching JYL, Zhang H, Leung KC, Lin WL. Exploring the efficacy and safety of Yu-Ping-Feng powder with variation against allergic rhinitis: a randomized, double-blind, placebo-controlled trial. Chin Med. 2025 May 26;20(1):70. doi: 10.1186/s13020-025-01120-2.
- Derived from this study: PubMed 36588672Cheong PK, Ho TM, Chan KL, Lo CW, Leung SB, Hon KL, Leung KC, Siu THC, Song TH, Zhang H, Ching JYL, Chow TY, Sum CH, Chia CP, Lin ZX. The efficacy and safety of Yupingfeng Powder with variation in the treatment of allergic rhinitis: Study protocol for a randomized, double-blind, placebo-controlled trial. Front Pharmacol. 2022 Dec 16;13:1058176. doi: 10.3389/fphar.2022.1058176. eCollection 2022.
- 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. This study is not recruiting at the moment.
Zhixiu Lin, PhD principal investigator
Hong Kong Institute of Integrative Medicine, The Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Yupingfeng Powder granules in people with Allergic Rhinitis, run by Prof. Lin Zhixiu at 1 site in Hong Kong.
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 5 inclusion and 7 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 7 Nov 2024. 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 Hong Kong. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The change in the Total Nasal Symptom Score (TNSS) (time frame: Week 8). 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?
On the ClinicalTrials.gov record for NCT04976023, which also lists 2 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 7 Nov 2024.