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

August 5, 2015 updated by: Chang Gung Memorial Hospital

Phase 3 Study of Qi-tonifying Chinese Herbal Products for Treatment of Allergic Rhinitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan
        • Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Okuda scoring system for allergic rhinitis severity, Short-form 36 (SF-36) for life quality, visual analogue scale for fatigue severity
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
immunologic biomarker assessment includes: CD4/CD8 count and ratio, relative cytokines of T Cell, activator mediator of PMNs and phargocytosis.
Laboratory examination on starting day (day 0), once a month during treatment course (day 30 and day 60)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Collaborators

Committee on Chinese Medicine and Pharmacy

Investigators

  • Principal Investigator: Sien-hung Yang, Ph.D., Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

June 17, 2012

First Submitted That Met QC Criteria

June 27, 2012

First Posted (Estimate)

June 28, 2012

Study Record Updates

Last Update Posted (Estimate)

August 7, 2015

Last Update Submitted That Met QC Criteria

August 5, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMRPD1B0081

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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