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Herbal Treatment for Perennial Allergic Rhinitis

This study has been completed.
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00456755
First received: April 4, 2007
Last updated: November 23, 2009
Last verified: November 2009
History of Changes
  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 2

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

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:

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 May 23, 2013