Herbal Treatment for Perennial Allergic Rhinitis

Perennial Allergic Rhinitis Clinical Trial

Official title:

A Herbal Formula (SBL) for the Treatment of Perennial Allergic Rhinitis: A Randomized, Double-blind, Placebo-controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00456755
• Other study ID #: ICM/CTS/03/333
• Status: Completed
• Phase: Phase 2
• First received: April 4, 2007
• Last updated: November 23, 2009
• Start date: March 2004
• Est. completion date: April 2006

Study information

• Verified date: November 2009
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Perennial Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic, Perennial

Intervention

Drug:
• Shi-Bi-Lin
4 weeks of treatment, dose of 1 g (two capsules), twice daily

Other:
• Placebo
4 weeks of colormatched placebo capsules, dose of 1 g (two capsules), twice daily

Locations

Country	Name	City	State
Hong Kong	Department of ENT, Prince of Wales Hospital	Hong Kong
Hong Kong	Department of ENT, Yan Chai Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (7)

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

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

Schmolz M, Ottendorfer D, März 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. — View Citation

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4		4 week	No
Secondary	Quality of Life (Difference Between Baseline and Week 4)		4 week	No