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

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04976023
• Other study ID #: A.Rhinitis study
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 12, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2022
• Source: Chinese University of Hong Kong
• Contact: Zhixiu Lin, PhD
• Phone: 35053476
• Email: linzx[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 . 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: December 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• Yupingfeng Powder granules
14.5 5 g twice daily for 8 weeks

Other:
• Placebo
14.5 5 g twice daily for 8 weeks

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Lin Zhixiu

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Week 8
Secondary	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	week 4, week 12 and week 16
Secondary	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	week 4, week 8, week 12 and week 16
Secondary	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	week 4, week 8, week 12 and week 16
Secondary	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	week 4, week 8, week 12 and week 16
Secondary	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.	week 8 and week 12
Secondary	The changes in the serum levels of cytokines (IL-10 and IL-17)	Serum responses will correlate with the nasal symptoms scores.	week 8 and week 12
Secondary	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.	week 8
Secondary	Adverse events related to study treatment	All adverse events that are related to the study treatment will be captured for analysis.	During study for 16 weeks