Effect of Qi-tonifying Chinese Herbal Products for Treatment of Allergic Rhinitis
Phase 3 Study of Qi-tonifying Chinese Herbal Products for Treatment of Allergic Rhinitis
1 other identifier
interventional
112
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2012
CompletedFirst Posted
Study publicly available on registry
June 28, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedAugust 7, 2015
August 1, 2015
1.4 years
June 17, 2012
August 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes from Baseline in symptom severity at 3 months
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 Outcomes (1)
Change from Baseline in immunologic biomarkers at 3 months
Laboratory examination on starting day (day 0), once a month during treatment course (day 30 and day 60)
Study Arms (2)
Control
PLACEBO COMPARATORcontrol 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.
Chinese herbal products (CHP)
EXPERIMENTALCHP group receive Qi-tonifying Chinese herbal products capsule, 3 times a day, 3gm each time, total 9gm per day
Interventions
Chinese herbal products in capsule, 3 times a day, 3gm (6PC of 500mg capsule) each time, total 9gm per day
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chang Gung Memorial Hospital
Taoyuan District, Taiwan
Related Publications (5)
Yang SH, Hong CY, Yu CL. Decreased serum IgE level, decreased IFN-gamma and IL-5 but increased IL-10 production, and suppressed cyclooxygenase 2 mRNA expression in patients with perennial allergic rhinitis after treatment with a new mixed formula of Chinese herbs. Int Immunopharmacol. 2001 Jun;1(6):1173-82. doi: 10.1016/s1567-5769(01)00051-0.
PMID: 11407311BACKGROUNDYang SH, Hong CY, Yu CL. The stimulatory effects of nasal discharge from patients with perennial allergic rhinitis on normal human neutrophils are normalized after treatment with a new mixed formula of Chinese herbs. Int Immunopharmacol. 2002 Nov;2(12):1627-39. doi: 10.1016/s1567-5769(02)00133-9.
PMID: 12469937BACKGROUNDYang SH, Yu CL. Antiinflammatory effects of Bu-zhong-yi-qi-tang in patients with perennial allergic rhinitis. J Ethnopharmacol. 2008 Jan 4;115(1):104-9. doi: 10.1016/j.jep.2007.09.011. Epub 2007 Sep 19.
PMID: 17980528BACKGROUNDYang SH, Yu CL, Chen YL, Chiao SL, Chen ML. Traditional Chinese medicine, Xin-yi-san, reduces nasal symptoms of patients with perennial allergic rhinitis by its diverse immunomodulatory effects. Int Immunopharmacol. 2010 Aug;10(8):951-8. doi: 10.1016/j.intimp.2010.05.008. Epub 2010 May 28.
PMID: 20546945BACKGROUNDFokkens WJ. Antigen-presenting cells in nasal allergy. Allergy. 1999 Nov;54(11):1130-41. doi: 10.1034/j.1398-9995.1999.00104.x. No abstract available.
PMID: 10604548BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sien-hung Yang, Ph.D.
Chang Gung Memorial Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2012
First Posted
June 28, 2012
Study Start
July 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
August 7, 2015
Record last verified: 2015-08