Clinical trial NCT00456755: Herbal Treatment for Perennial Allergic Rhinitis
Official title: A Herbal Formula (SBL) for the Treatment of Perennial Allergic Rhinitis: A Randomized, Double-blind, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Perennial Allergic Rhinitis
Keywords: Perennial Allergic rhinitis
Traditional Chinese Medicine
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2007-04-05
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Allergic rhinitis(AR) is one of the most common allergic disorders throughout the world.The conventional therapies are effective in alleviating symptoms but the efficacy are limited and not persistent. Furthermonre, the cost and side-effect are known defects. A classical Chinese herbal formula, has been used for AR for centries. Our study purpose is to evaluate the clinical efficacy and safety of this formula verus placebo in perennial allergic rhinitis (PAR).

Hypothesis: the classical herbal formula would improve the symptoms of PAR patients and change some immunological parameters in the peripheral blood when comparing with the placebo.

Detailed description: It is a randomized, double-blind, placebo-controlled trial.

Eligibility criteria: Inclusion Criteria:

* Aged from 18 to 65 years old
* Have typical symotoms of PAR including rhinirrhea, sneezing, nasal obstruction and itching in nose and eyes for at least 2 previous consecutive years.
* Postive skin prick test(SPT) to hose dust mite, mold, animal dander and cockcroach with regular AR medications withould for 3 days prior to the test

Exclusion Criteria:

* Pregnant women and women at risk of conception
* Received allergen injections in previous 2 years
* Regular medications for AR or cold and other allergic disorder
* Seasonal allergic rhinitis, vasomotor rhinitis and rhinitis medicamentosa
* Nasal structure deformities, nasal polyps and hypertrophic rhinitis
* Systematic cortisosteroid used within recent 3 months or nasal cortisosteroid with 15 days
* Other active respiratory disorders
* Active medical disorders: cancer, infection, hematology, renal, hepatic, cardiovascular, metabolic and gastrointestinal diseases

Primary outcomes:
measure: Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4
timeFrame: 4 week
Secondary outcomes:
measure: Quality of Life (Difference Between Baseline and Week 4)
timeFrame: 4 week
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of ENT, Prince of Wales Hospital
city: Hong Kong
country: Hong Kong
facility: Department of ENT, Yan Chai Hospital
Study officials:
affiliation: Department of ENT, Prince of Wales Hospital, The Chinese University of Hong Kong
name: Zhao Yu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leung R, Ho P. Asthma, allergy, and atopy in three south-east Asian populations. Thorax. 1994 Dec;49(12):1205-10. doi: 10.1136/thx.49.12.1205.
citation: Spector SL. Overview of comorbid associations of allergic rhinitis. J Allergy Clin Immunol. 1997 Feb;99(2):S773-80. doi: 10.1016/s0091-6749(97)70126-x.
citation: Worldwide variation in prevalence of symptoms of asthma, allergic rhinoconjunctivitis, and atopic eczema: ISAAC. The International Study of Asthma and Allergies in Childhood (ISAAC) Steering Committee. Lancet. 1998 Apr 25;351(9111):1225-32.
citation: Nash DB, Sullivan SD, Mackowiak J. Optimizing quality of care and cost effectiveness in treating allergic rhinitis in a managed care setting. Am J Manag Care. 2000 Jan;6(1 Suppl):S3-15; quiz S19-20.
citation: Bielory L, Lupoli K. Herbal interventions in asthma and allergy. J Asthma. 1999;36(1):1-65. doi: 10.3109/02770909909065150.
citation: Ziment I, Tashkin DP. Alternative medicine for allergy and asthma. J Allergy Clin Immunol. 2000 Oct;106(4):603-14. doi: 10.1067/mai.2000.109432.
citation: Schmolz M, Ottendorfer D, Marz RW, Sieder C. Enhanced resistance to Sendai virus infection in DBA/2J mice with a botanical drug combination (Sinupret). Int Immunopharmacol. 2001 Sep;1(9-10):1841-8. doi: 10.1016/s1567-5769(01)00108-4.