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

NCT ID: NCT04976023

Last Updated: 2024-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-12
• Study Completion Date: 2023-06-20

Brief 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.

Detailed 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.

Conditions

Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active Arm

14.55g of Yupingfeng Powder granules twice daily for 8 weeks

Group Type: ACTIVE_COMPARATOR

Yupingfeng Powder granules

Intervention Type: DRUG

14.5 5 g twice daily for 8 weeks

Placebo Arm

14.55g of placebo granules twice daily for 8 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

14.5 5 g twice daily for 8 weeks

Interventions

Yupingfeng Powder granules

14.5 5 g twice daily for 8 weeks

Intervention Type: DRUG

Placebo

14.5 5 g twice daily for 8 weeks

Intervention Type: OTHER

Other Intervention Names

Yupingfeng Powder with variation; Placebo granules

Eligibility Criteria

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.

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prof. Lin Zhixiu

OTHER

Sponsor Role: lead

Responsible Party

Prof. Lin Zhixiu

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Zhixiu Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

Hong Kong Institute of Integrative Medicine, The Chinese University of Hong Kong

Locations

The Chinese University of Hong Kong

Shatin, , Hong Kong

Countries

Hong Kong

References

Lin ZX, Ho TM, Xian YF, Chan KL, Xu QQ, Lo CW, Wu JCY, Hon KL, Leung SB, Chia CP, Sum CH, Chow TY, Cheong PK, Ching JYL, Zhang H, Leung KC, Lin WL. Exploring the efficacy and safety of Yu-Ping-Feng powder with variation against allergic rhinitis: a randomized, double-blind, placebo-controlled trial. Chin Med. 2025 May 26;20(1):70. doi: 10.1186/s13020-025-01120-2.

Reference Type: DERIVED

PMID: 40420199 (View on PubMed)

Cheong PK, Ho TM, Chan KL, Lo CW, Leung SB, Hon KL, Leung KC, Siu THC, Song TH, Zhang H, Ching JYL, Chow TY, Sum CH, Chia CP, Lin ZX. The efficacy and safety of Yupingfeng Powder with variation in the treatment of allergic rhinitis: Study protocol for a randomized, double-blind, placebo-controlled trial. Front Pharmacol. 2022 Dec 16;13:1058176. doi: 10.3389/fphar.2022.1058176. eCollection 2022.

Reference Type: DERIVED

PMID: 36588672 (View on PubMed)

Other Identifiers

A.Rhinitis study

Identifier Type: -

Identifier Source: org_study_id