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NCT Number: NCT04976023

The Effects of Using Yupingfeng Powder with Variation for the Treatment of Allergic Rhinitis

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.

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Key information

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Chinese University of Hong Kong

Shatin, Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Yupingfeng Powder granules

Drug

14.5 5 g twice daily for 8 weeks

Other names: Yupingfeng Powder with variation

Placebo

Other

14.5 5 g twice daily for 8 weeks

Other names: Placebo granules

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. The change in the Total Nasal Symptom Score (TNSS)

    Time frame: week 4, week 12 and week 16

    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

  2. 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 VAS ranges from 0 (nasal symptom free) to 10 (nasal symptom extremely bothersome) to assess the severity of nasal symptom disturbance

  3. 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 lower the score the higher the quality of life

  4. 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 lower the score the higher the quality of life

  5. The changes in the serum levels of specific IgE

    Time frame: week 8 and week 12

    The serum levels of cytokines and IgE will be tested. The higher the value, the more severity of the symptoms.

  6. The changes in the serum levels of cytokines (IL-10 and IL-17)

    Time frame: week 8 and week 12

    Serum responses will correlate with the nasal symptoms scores.

  7. The changes in the gut microbiota composition in stools

    Time frame: week 8

    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.

  8. Adverse events related to study treatment

    Time frame: During study for 16 weeks

    All adverse events that are related to the study treatment will be captured for analysis.

Sponsors and collaborators

Lead sponsor

Prof. Lin Zhixiu

Other

Registry information

Official study title

The Effects of Using Yupingfeng Powder with Variation for the Treatment of Allergic Rhinitis(AR):a Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 26, 2021
Registry last updated
Nov 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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