Herbal Treatment for Perennial Allergic Rhinitis

Phase 2

Completed

• Conditions: Perennial Allergic Rhinitis
• Interventions: Drug: Shi-Bi-Lin; Other: Placebo

• Registration Number: NCT00456755
• Lead Sponsor: 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.

Detailed Description

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

Study Timeline

• Study Start: 2004-03
• Primary Completion: 2006-04
• Study Completion: 2006-04
• Study First Submitted: 2007-04-04
• Study First Submitted QC: 2007-04-04
• Study First Posted: 2007-04-05
• Status Verified: 2009-11
• Results First Submitted: 2009-11-23
• Results First Submitted QC: 2009-11-23
• Last Update Submitted: 2009-11-23
• Results First Posted: 2010-01-06
• Last Update Posted: 2010-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shi-Bi-Lin	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).
Placebo	Placebo	The placebo contained brown colored starch resembling the SBL powder

Primary Outcome Measures

Name	Time	Method
Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4	4 week	The severity of PAR was evaluated by means of a daily symptom diary chart. Patients were instructed to grade retrospectively everyday before bedtime, their generalwell-being, nasalsymptoms (nasal blockage, rhinorrhea, nose itching, sneezing) and non-nasal symptoms(itching eyes, tearing eyes, redness of eyes, itching of ears or palate) on the diary chart. A 4-point severity scale from no symptoms (0), mild (1), moderated (2) to severe (3) was used.

Secondary Outcome Measures

Name	Time	Method
Quality of Life (Difference Between Baseline and Week 4)	4 week	SF-36 QOL questionnaire administrated before and after treatment. It has eight domains: general health (GH), physical functioning (PF), social functioning (SF), role limitation caused by physical problems (RP), bodily pain (BP), role limitations caused by emotional problem (RE), mental health (MH), and vitality (VT). Each domain was started from 0 (worst health) to 100 (best health).

Trial Locations

Locations (2)

Department of ENT, Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong

Department of ENT, Yan Chai Hospital; 🇭🇰 Hong Kong, Hong Kong