Study of Yupingfeng Powder Treating Allergic Rhinitis (AR)

NCT06608017 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: Allergic Rhinitis Study
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

allergic rhinitis; Chinese Medicine; Yupingfeng Powder; TCM

Outcome Measures

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.

  week 8

Secondary Outcomes (15)

• The change in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score

  week 4

• The change in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score

  week 12

• The change in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score

  week 16

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

  week 4

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

  week 8

Study Arms (2)

Yupingfeng Powder with variation

EXPERIMENTAL

Granules form, 2 times per day for 8 weeks

Drug: Chinese Herbal Medicine granules

Placebo

PLACEBO COMPARATOR

Granules form, 2 times per day for 8 weeks

Other: Placebo

Interventions

Chinese Herbal Medicine granules DRUG

Treatment group

Also known as: Yupingfeng Powder with variation

Yupingfeng Powder with variation

Placebo OTHER

Placebo-controlled group

Also known as: Placebo granules

Placebo

Eligibility Criteria

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

You may qualify if:

• 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;
• 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 exceeds the upper limit of the reference value by 2 times ;
• Known alcohol and / or drug abuse;
• Known allergic history to any Chinese herbal medicines;
• Known pregnant or lactating.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

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

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhixiu LIN, PhD

CONTACT

+85235053476; linzx@cuhk.edu.hk

Cho Wing LO

CONTACT

+85235053476; louislo@cuhk.edu.hk

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: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized, double-blinded, placebo controlled trial

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: October 1, 2024
• Primary Completion: August 31, 2025
• Study Completion: October 31, 2025
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share