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临床试验/NCT06608017
NCT06608017招募中2 期

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

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年3月27日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
入组人数
140
试验地点
1
主要终点
The change in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score

研究概览

简要总结

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.

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.

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 Powder 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 Powder 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, a double-blind, randomized, placebo-controlled clinical trial design with strong scientific rigor will be employed in this study, and it would be able to provide robust clinical evidence on the efficacy and safety of Yupingfeng Powder with variation for AR.

Recruited subjects will be 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.

In our previous study, it is shown that Yupingfeng Powder can significantly improve the symptoms of AR, and there was no serious adverse event reported by the subjects. And in this project, we modify the design of the trial to further investigate the efficacy of Yupingfeng Powder with variation for AR patients with a larger sample size.

详细描述

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. Severe AR has been associated with significant impairments in quality of life, sleep and work performance. AR is a prevalent clinical disease that can occur at any age. The pathogenesis of this disease is mainly due to that patient has an allergic physique. Still, it is also related to patients' living habits and affected by the patients' living environment.

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. If the condition is not handled properly, it can cause various complications such as sleep disturbance, general fatigue, loss of appetite, loss of attention and disturbance to learning.

The development of AR requires an interaction between the environment, immune system, and genetic susceptibility. Several cells, cytokines, and chemokines orchestrate and maintain allergic inflammation. Cytokines play an essential role in mediating allergic inflammation. The importance of the T helper cell (Th) 2 cytokines in both the development of allergic sensitization and pathology of allergic inflammation is well established. While healthy subjects are predominated by Th1-type cells, nasal mucosa and epithelial tissues of AR subjects are dominated by Th2-type lymphocytes. AR is determined by a disequilibrium of T helper cells with a predominance of Th2-type cytokines but normal levels of Th1-type cytokines. Another subtype of T-cell, regulatory T-cell (Tregs), suppresses both Th1 and Th2-type cytokine expression. Thus, it has been suggested that in AR, an imbalance between Th2 and Treg-cells exists as well.

Characteristic cytokine known for Th1 cell such as IFN-γ is a key cytokine in bridging the innate and the adaptive arms of the immune system. In addition to its role in the development of a Th1-type response, IFN-γ plays a role in the regulation of local leukocyte-endothelial interactions.

On the other hand, Tregs has restrictive influences on both Th1 and Th2 cell-mediated inflammation. The lack of Tregs causes the emergence of allergic inflammation along with the increase in Th2 cells. The Tregs bring the allergic inflammation under control by synthesizing IL-10 and the transforming growth factor-β (TGF-β). Allergic patients show an allergen-specific functional defect in Treg that promotes Th2 polarization and consequently IgE synthesis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Aged 18 or above;
  • •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;
  • •Understand Chinese;
  • •Voluntary written consent.

排除标准

  • •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 exceeds the upper limit of the reference value by 2 times ;
  • •Known alcohol and / or drug abuse;
  • •Known allergic history to any Chinese herbal medicines;
  • •Known pregnant or lactating.

研究组 & 干预措施

Yupingfeng Powder with variation

Experimental

Granules form, 2 times per day for 8 weeks

干预措施: Chinese Herbal Medicine granules (Drug)

Placebo

Placebo Comparator

Granules form, 2 times per day for 8 weeks

干预措施: Placebo (Other)

结局指标

主要结局

The change in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score

时间窗: week 8

The RQLQ is a disease-specific questionnaire that can assess quality of life impairment in AR patients. This questionnaire consists of 28 questions covering 7 domains including activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms and emotional problems. The lower the score the higher the quality of life.

次要结局

  • The change in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score(week 4)
  • The change in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score(week 12)
  • The changes in frequency of AR episodes and their severity (visual analog scale, VAS)(week 4)
  • The changes in frequency of AR episodes and their severity (visual analog scale, VAS)(week 8)
  • The changes in frequency of AR episodes and their severity (visual analog scale, VAS)(week 12)
  • The changes in the Total Nasal Symptom Score (TNSS)(week 4)
  • The changes in the Total Nasal Symptom Score (TNSS)(week 8)
  • The changes in the Total Nasal Symptom Score (TNSS)(week 12)
  • The changes in the serum levels of total IgE and cytokines (IL-10 and IL-17)(week 8)
  • The change in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score(week 16)
  • The changes in frequency of AR episodes and their severity (visual analog scale, VAS)(week 16)
  • The changes in the Total Nasal Symptom Score (TNSS)(week 16)
  • The changes in the serum levels of total IgE and cytokines (IL-10 and IL-17)(week 12)
  • The changes in the gut microbiota composition in stools(week 8)
  • Adverse events (graded by CTCAE) related to study treatment(During study for 16 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Lin Zhixiu

Professor

Chinese University of Hong Kong

研究点 (1)

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