Herbal Treatment for Perennial Allergic Rhinitis

NCT ID: NCT00456755

Last Updated: 2010-01-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2006-04-30

Brief Summary

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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

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

Conditions

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Perennial Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Shi-Bi-Lin

Intervention Type DRUG

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

Placebo

The placebo contained brown colored starch resembling the SBL powder

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Shi-Bi-Lin

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

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Other Intervention Names

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Modified from the classic formula Cang-Er-Zi-San.

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Institute of Chinese Medicine, Chinese University of Hong Kong

Principal Investigators

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Zhao Yu, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Department of ENT, Prince of Wales Hospital

Hong Kong, , Hong Kong

Site Status

Department of ENT, Yan Chai Hospital

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

References

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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.

Reference Type BACKGROUND
PMID: 7878553 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9042070 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9643741 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11009751 (View on PubMed)

Bielory L, Lupoli K. Herbal interventions in asthma and allergy. J Asthma. 1999;36(1):1-65. doi: 10.3109/02770909909065150.

Reference Type BACKGROUND
PMID: 10077136 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11031328 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11562075 (View on PubMed)

Other Identifiers

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ICM/CTS/03/333

Identifier Type: -

Identifier Source: org_study_id

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