Phase 2 N=126 Randomized Quadruple-blind Treatment

Herbal Treatment for Perennial Allergic Rhinitis

Perennial Allergic Rhinitis

Bottom Line

View on ClinicalTrials.gov: NCT00456755 ↗

Enrolled (actual)

126

Serious AEs

0.0%

Results posted

Jan 2010

Primary outcome: Primary: Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4 — 2.82; 2.8; 1.19; 1.21 Unit Score

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Shi-Bi-Lin (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Chinese University of Hong Kong
Primary completion: Apr 2006

Outcome Measures

Outcome	Result	p-value
PRIMARY Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4	2.82; 2.8; 1.19; 1.21; 1.26; 1.24	—
SECONDARY Quality of Life (Difference Between Baseline and Week 4)	4; 0; 7; 3; -3; -10	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00456755). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.