Herbal Treatment for Perennial Allergic Rhinitis
|ClinicalTrials.gov Identifier: NCT00456755|
Recruitment Status : Completed
First Posted : April 5, 2007
Results First Posted : January 6, 2010
Last Update Posted : January 6, 2010
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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).
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
4 weeks of colormatched placebo capsules, dose of 1 g (two capsules), twice daily
- Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4 [ Time Frame: 4 week ]
- Quality of Life (Difference Between Baseline and Week 4) [ Time Frame: 4 week ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00456755
|Department of ENT, Prince of Wales Hospital|
|Hong Kong, Hong Kong|
|Department of ENT, Yan Chai Hospital|
|Hong Kong, Hong Kong|
|Principal Investigator:||Zhao Yu, PhD||Department of ENT, Prince of Wales Hospital, The Chinese University of Hong Kong|