Herbal Treatment for Perennial Allergic Rhinitis - Full Text View

Sponsor:	Chinese University of Hong Kong
Information provided by:	Chinese University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00456755

Purpose

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.

Condition	Intervention	Phase
Perennial Allergic Rhinitis	Drug: Shi-Bi-Lin Other: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Herbal Formula (SBL) for the Treatment of Perennial Allergic Rhinitis: A Randomized, Double-blind, Placebo-controlled Clinical Trial

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:

Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4 [ Time Frame: 4 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of Life (Difference Between Baseline and Week 4) [ Time Frame: 4 week ] [ Designated as safety issue: No ]

Enrollment:	126
Study Start Date:	March 2004
Study Completion Date:	April 2006
Primary Completion Date:	April 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Shi-Bi-Lin Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba).	Drug: Shi-Bi-Lin 4 weeks of treatment, dose of 1 g (two capsules), twice daily Other Name: Modified from the classic formula Cang-Er-Zi-San.
Placebo Comparator: Placebo The placebo contained brown colored starch resembling the SBL powder	Other: Placebo 4 weeks of colormatched placebo capsules, dose of 1 g (two capsules), twice daily Other Name: Placebo

Arms

Assigned Interventions

Active Comparator: Shi-Bi-Lin

Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba).

Drug: Shi-Bi-Lin

4 weeks of treatment, dose of 1 g (two capsules), twice daily

Other Name: Modified from the classic formula Cang-Er-Zi-San.

Placebo Comparator: Placebo

The placebo contained brown colored starch resembling the SBL powder

Other: Placebo

4 weeks of colormatched placebo capsules, dose of 1 g (two capsules), twice daily

Other Name: Placebo

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00456755

Locations

Hong Kong
Department of ENT, Prince of Wales Hospital
Hong Kong, Hong Kong
Department of ENT, Yan Chai Hospital
Hong Kong, Hong Kong

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

Principal Investigator:

Zhao Yu, PhD

Department of ENT, Prince of Wales Hospital, The Chinese University of Hong Kong

More Information

Publications:

Leung R, Ho P. Asthma, allergy, and atopy in three south-east Asian populations. Thorax. 1994 Dec;49(12):1205-10.

Spector SL. Overview of comorbid associations of allergic rhinitis. J Allergy Clin Immunol. 1997 Feb;99(2):S773-80. Review.

[No authors listed] 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.

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.

Bielory L, Lupoli K. Herbal interventions in asthma and allergy. J Asthma. 1999;36(1):1-65. Review.

Ziment I, Tashkin DP. Alternative medicine for allergy and asthma. J Allergy Clin Immunol. 2000 Oct;106(4):603-14. Review.

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.

Responsible Party:	Zhao Yu, Department of Otorhinolaryngology, Head & Neck Surgery, West China Hospital, Sichuan University, Institute of Chinese Medicine, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00456755 History of Changes
Other Study ID Numbers:	ICM/CTS/03/333
Study First Received:	April 4, 2007
Results First Received:	November 23, 2009
Last Updated:	November 23, 2009
Health Authority:	Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:

Perennial Allergic rhinitis
Traditional Chinese Medicine

Additional relevant MeSH terms:

Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on February 12, 2012