Study of Yupingfeng Powder Treating Allergic Rhinitis (AR)
NCT06608017 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 140
Last updated 2024-09-25
Summary
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.
Conditions
- Allergic Rhinitis
Interventions
- DRUG
-
Chinese Herbal Medicine granules
Treatment group
- OTHER
-
Placebo
Placebo-controlled group
Sponsors & Collaborators
-
Chinese University of Hong Kong
lead OTHER
Principal Investigators
-
Zhixiu Lin, PhD · Chinese University of Hong Kong
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-10-01
- Primary Completion
- 2025-08-31
- Completion
- 2025-10-31
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