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

NCT04976023 | Completed Phase 2 DMC

• 1 other identifier: A.Rhinitis study
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis

Keywords

Allergic Rhinitis; Yupingfeng Powder variation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 8

Secondary Outcomes (8)

• The change in the Total Nasal Symptom Score (TNSS)

  week 4, week 12 and week 16

• The changes in frequency of AR episodes and their severity on visual analog scale (VAS)

  week 4, week 8, week 12 and week 16

• The changes in quality of life by using The changes in the Paediatric Allergic Disease Quality of Life Questionnaire (PADQLQ)

  week 4, week 8, week 12 and week 16

• The changes in quality of life by using The changes in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)

  week 4, week 12 and week 16

• The changes in the serum levels of specific IgE

  week 8 and week 12

Study Arms (2)

Active Arm

ACTIVE COMPARATOR

14.55g of Yupingfeng Powder granules twice daily for 8 weeks

Drug: Yupingfeng Powder granules

Placebo Arm

PLACEBO COMPARATOR

14.55g of placebo granules twice daily for 8 weeks

Other: Placebo

Interventions

Yupingfeng Powder granules DRUG

14.5 5 g twice daily for 8 weeks

Also known as: Yupingfeng Powder with variation

Active Arm

Placebo OTHER

14.5 5 g twice daily for 8 weeks

Also known as: Placebo granules

Placebo Arm

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prof. Lin Zhixiu: lead

Study Sites (1)

The Chinese University of Hong Kong

Shatin, Hong Kong

Location

Related Publications (2)

• 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.

  PMID: 40420199 DERIVED

• 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.

  PMID: 36588672 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Zhixiu Lin, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: July 26, 2021
• Study Start: April 12, 2022
• Primary Completion: June 20, 2023
• Study Completion: June 20, 2023
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)