Herbal Treatment for Perennial Allergic Rhinitis

Study Overview
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Brief Summary
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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
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It is a randomized, double-blind, placebo-controlled trial.

Official Title
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A Herbal Formula (SBL) for the Treatment of Perennial Allergic Rhinitis: A Randomized, Double-blind, Placebo-controlled Clinical Trial

Conditions
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Perennial Allergic Rhinitis

Intervention / Treatment
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* Drug: Shi-Bi-Lin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Shi-Bi-Lin<br>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<br>* 4 weeks of treatment, dose of 1 g (two capsules), twice daily<br>* Other names: Modified from the classic formula Cang-Er-Zi-San.;|
| Placebo Comparator: Placebo<br>The placebo contained brown colored starch resembling the SBL powder | Other: Placebo<br>* 4 weeks of colormatched placebo capsules, dose of 1 g (two capsules), twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4 | 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. | 4 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (Difference Between Baseline and Week 4) | 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). | 4 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perennial Allergic rhinitis, Traditional Chinese Medicine