Herbal Treatment for Perennial Allergic Rhinitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00456755
Recruitment Status : Completed
First Posted : April 5, 2007
Results First Posted : January 6, 2010
Last Update Posted : January 6, 2010
Information provided by:
Chinese University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Perennial Allergic Rhinitis Drug: Shi-Bi-Lin Other: Placebo Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2004
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4 [ Time Frame: 4 week ]

Secondary Outcome Measures :
  1. Quality of Life (Difference Between Baseline and Week 4) [ Time Frame: 4 week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00456755

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
Principal Investigator: Zhao Yu, PhD Department of ENT, Prince of Wales Hospital, The Chinese University of Hong Kong

Responsible Party: Zhao Yu, Department of Otorhinolaryngology, Head & Neck Surgery, West China Hospital, Sichuan University, Institute of Chinese Medicine, Chinese University of Hong Kong Identifier: NCT00456755     History of Changes
Other Study ID Numbers: ICM/CTS/03/333
First Posted: April 5, 2007    Key Record Dates
Results First Posted: January 6, 2010
Last Update Posted: January 6, 2010
Last Verified: November 2009

Keywords provided by Chinese University of Hong Kong:
Perennial Allergic rhinitis
Traditional Chinese Medicine

Additional relevant MeSH terms:
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases