Herbal Treatment for Perennial Allergic Rhinitis - Tabular View

Tracking Information

First Received Date ^ICMJE

April 4, 2007

Last Updated Date

April 4, 2007

Start Date ^ICMJE

March 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Allergic rhinitis symptom score including rhinorrhea, nasal obstruction, sneezing, itchy nose and itchy eyes.
Immunological parameters in peripheral blood.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Quality of life
Adverse event

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Herbal Treatment for Perennial Allergic Rhinitis

Official Title ^ICMJE

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

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.

Detailed Description

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Perennial Allergic Rhinitis

Intervention ^ICMJE

Drug: Cang Er Zhi San Plus

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

126

Completion Date

April 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Hong Kong

Administrative Information

NCT ID ^ICMJE

NCT00456755

Responsible Party

Study ID Numbers ^ICMJE

ICM/CTS/03/333

Study Sponsor ^ICMJE

Chinese University of Hong Kong

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Zhao Yu, PhD

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

Information Provided By

Chinese University of Hong Kong

Verification Date

April 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP