Effect of Qi-tonifying Chinese Herbal Products for Treatment of Allergic Rhinitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Chang Gung Memorial Hospital
Sponsor:
Collaborator:
Committee on Chinese Medicine and Pharmacy
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01631032
First received: June 17, 2012
Last updated: March 15, 2013
Last verified: July 2012
  Purpose

Allergic rhinitis is a common but complicated immunologic disorder disease and multiple western medicine has been used for symptom control. Chinese herbal medicine, one of the most commonly used complementary and alternative medicine in Taiwan, has also be used for allergic rhinitis control. This study is designed to explore the efficacy and possible underlying immune-modulation effect of the BZYQT, which is one of the most famous Chinese herbal medicine used for allergic rhinitis in daily practice.


Condition Intervention Phase
Allergic Rhinitis
Drug: Qi-tonifying Chinese herbal products
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Qi-tonifying Chinese Herbal Products for Treatment of Allergic Rhinitis

Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Changes from Baseline in symptom severity at 3 months [ Time Frame: Assessment of symptom severity on starting day (day 0), once a month during treatment course (day 30 and day 60), and 1 month after completed treatment (day 90) ] [ Designated as safety issue: No ]
    Okuda scoring system for allergic rhinitis severity, Short-form 36 (SF-36) for life quality, visual analogue scale for fatigue severity


Secondary Outcome Measures:
  • Change from Baseline in immunologic biomarkers at 3 months [ Time Frame: Laboratory examination on starting day (day 0), once a month during treatment course (day 30 and day 60) ] [ Designated as safety issue: No ]
    immunologic biomarker assessment includes: CD4/CD8 count and ratio, relative cytokines of T Cell, activator mediator of PMNs and phargocytosis.


Estimated Enrollment: 120
Study Start Date: July 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
control group receive placebo capsule with same look, smell and flavor compared with experiment group. The scheme for medication is 3 times a day, 3gm each time, total 9gm per day.
Experimental: Chinese herbal products (CHP)
CHP group receive Qi-tonifying Chinese herbal products capsule, 3 times a day, 3gm each time, total 9gm per day
Drug: Qi-tonifying Chinese herbal products
Chinese herbal products in capsule, 3 times a day, 3gm (6PC of 500mg capsule) each time, total 9gm per day
Other Names:
  • Bu Zhong Yi Qi Tang
  • Hochu-ekki-to

Detailed Description:

Allergic rhinitis is the type I hypersensitivity reaction of nasal mucosa to environmental allergen. It is characterized by one or more symptoms including sneezing, itching , rhinorrhea and nasal congestion. The prevalence of allergic rhinitis in Taiwan is approximately 20%-30% and increases annually. However, symptom relapse still bothered the majority of patients though there were certain advances in western medicine. In addition, side effects of western medicine, such as lethargy, mouth dryness after taking anti-histamine and immunosuppression after using steroid are also concerned by patient.

Traditional Chinese medicine has been used widely in Taiwan for several disease, especially allergic diseases, such as allergic rhinitis. Among all Chinese herbal products, qi-tonifying regimen play a central role for allergic diseases control. Bu-zhong-yi-qi-tang (BZYQT), one of the famous qi-tonifying herbal products, has been proved to have immuno-modulation effect in previous studies. However, proof of clinical investigation of therapeutic efficacy and cellular level response are still lacking.

In this study, a double-blinded, randomized, placebo control design is applied and total 120 intermittent allergic rhinitis patients will be enrolled in our study. All subjects will be divided into BZYQT and placebo control groups, each group will have 60 subjects. Subjects of BZYQT group will receive capsule of BZYQT, 3gm tid, 9gm a day, while control group will receive similar placebo capsule with same scheme. Total 2 month treatment course will be done. Clinical evaluation, including symptom severity, quality of life and chronic fatigue degree will be done once per month and one month after completed treatment. Additionally, various parameters for immunologic response will be checked before and after the treatment, including the total IgE amount, the ratio of CD4/CD8 of T lymphocytes, the profile of cytokine such as IL-4,IL-5,IL-8,IL-10,IL-13, IFN-γ as well as PGE2, LTC4, sICAM-1 , the mRNA expression of COX2 and neutrophil phagocytosis. Dendritic cell function, presumably the most important immune-response inducer, will also be checked through test for IL-10 and IL-12.

Results will be analyzed statistically including gender analysis. We hope that therapeutic efficacy and possible cellular mechanism of immune-modulation will be elucidated after completing this clinical trial.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with one or more following symptoms: nose itching, sneezing, rhinorrhea with clear nasal discharge, stuffy nose.
  • exacerbation times less than 4 days a week or consecutive episodes less than four weeks
  • Mite allergy confirmed by Childhood Allergy Panel (CAP)

Exclusion Criteria:

  • Use of steroid, antihistamine, Montelukast or other immuno-modulation drugs or duration of drug discontinuation less than one month
  • Active infection, including sinusitis
  • Vasomotor rhinitis
  • Unable to swallow capsule or history of poor medication compliance
  • Major organ dysfunction with relevant impaired physical performance status
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01631032

Contacts
Contact: Sien-hung Yang, Ph.D. +886-3-3196200 ext 2611 dryang@ms1.hinet.net
Contact: Hsing-yu Chen, M.D. +886-3-3196200 ext 2611 b8705016@gmail.com

Locations
Taiwan
Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan
Contact: Hsing-yu Chen, M.D.    +886-3-3196200 ext 2611      
Principal Investigator: Sien-hung Yang, Ph.D.         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Committee on Chinese Medicine and Pharmacy
Investigators
Principal Investigator: Sien-hung Yang, Ph.D. Chang Gung Memorial Hospital
  More Information

Publications:
Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01631032     History of Changes
Other Study ID Numbers: PMRPD1B0081
Study First Received: June 17, 2012
Last Updated: March 15, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by Chang Gung Memorial Hospital:
Allergic rhinitis
Chinese herbal products
Qi deficiency

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on July 20, 2014