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

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ClinicalTrials.gov Identifier: NCT04976023
Recruitment Status : Recruiting
First Posted : July 26, 2021
Last Update Posted : June 27, 2022
Sponsor:
Information provided by (Responsible Party):
Prof. Lin Zhixiu, Chinese University of Hong Kong

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.


Condition or disease Intervention/treatment Phase
Allergic Rhinitis Drug: Yupingfeng Powder granules Other: Placebo Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Using Yupingfeng Powder With Variation for the Treatment of Allergic Rhinitis(AR):a Randomized Controlled Trial
Actual Study Start Date : April 12, 2022
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : December 31, 2023

Arm Intervention/treatment
Active Comparator: Active Arm
14.55g of Yupingfeng Powder granules twice daily for 8 weeks
Drug: Yupingfeng Powder granules
14.5 5 g twice daily for 8 weeks
Other Name: Yupingfeng Powder with variation

Placebo Comparator: Placebo Arm
14.55g of placebo granules twice daily for 8 weeks
Other: Placebo
14.5 5 g twice daily for 8 weeks
Other Name: Placebo granules




Primary Outcome Measures :
  1. The change in the Total Nasal Symptom Score (TNSS) [ Time Frame: Week 8 ]
    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


Secondary Outcome Measures :
  1. The change in the Total Nasal Symptom Score (TNSS) [ Time Frame: week 4, week 12 and week 16 ]
    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

  2. The changes in frequency of AR episodes and their severity on visual analog scale (VAS) [ Time Frame: week 4, week 8, week 12 and week 16 ]
    The VAS ranges from 0 (nasal symptom free) to 10 (nasal symptom extremely bothersome) to assess the severity of nasal symptom disturbance

  3. The changes in quality of life by using The changes in the Paediatric Allergic Disease Quality of Life Questionnaire (PADQLQ) [ Time Frame: week 4, week 8, week 12 and week 16 ]
    The lower the score the higher the quality of life

  4. The changes in quality of life by using The changes in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) [ Time Frame: week 4, week 8, week 12 and week 16 ]
    The lower the score the higher the quality of life

  5. The changes in the serum levels of specific IgE [ Time Frame: week 8 and week 12 ]
    The serum levels of cytokines and IgE will be tested. The higher the value, the more severity of the symptoms.

  6. The changes in the serum levels of cytokines (IL-10 and IL-17) [ Time Frame: week 8 and week 12 ]
    Serum responses will correlate with the nasal symptoms scores.

  7. The changes in the gut microbiota composition in stools [ Time Frame: week 8 ]
    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.

  8. Adverse events related to study treatment [ Time Frame: During study for 16 weeks ]
    All adverse events that are related to the study treatment will be captured for analysis.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04976023


Contacts
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Contact: Zhixiu Lin, PhD 35053476 linzx@cuhk.edu.hk
Contact: Jessica Y.L. Ching, MPH 35053524 jessicaching@cuhk.edu.hk

Locations
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Hong Kong
The Chinese University of Hong Kong Recruiting
Shatin, Hong Kong
Contact: Zhi-xiu Lin, PhD       linzx@cuhk.edu.hk   
Sponsors and Collaborators
Prof. Lin Zhixiu
Investigators
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Principal Investigator: Zhixiu Lin, PhD Hong Kong Institute of Integrative Medicine, The Chinese University of Hong Kong
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Responsible Party: Prof. Lin Zhixiu, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04976023    
Other Study ID Numbers: A.Rhinitis study
First Posted: July 26, 2021    Key Record Dates
Last Update Posted: June 27, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Lin Zhixiu, Chinese University of Hong Kong:
Allergic Rhinitis
Yupingfeng Powder variation
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Respiratory Tract Infections
Infections
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases