Study of Yupingfeng Powder Treating Allergic Rhinitis (AR)
ConditionAllergic Rhinitis
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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 ;
Trial design
Design model
Parallel
Treatments tested in this trial
Chinese Herbal Medicine granules
DrugTreatment group
Placebo
Other interventionPlacebo-controlled group
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Yupingfeng Powder with variationExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
The change in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score
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.
Time frame
week 8Secondary outcomes
1
The change in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score
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.
Time frame
week 42
The change in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score
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.
Time frame
week 123
The change in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score
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.
Time frame
week 164
The changes in frequency of AR episodes and their severity (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 and has been validated for use in the quantitative evaluation of AR severity. The higher the score, the more severity of the symptoms.
Time frame
week 4Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov