Herbal Treatment for Perennial Allergic Rhinitis

The Chinese University of Hong Kong

Status and phase: Completed; Phase 2

Conditions: Perennial Allergic Rhinitis

Treatments: Drug: Shi-Bi-Lin; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00456755

ICM/CTS/03/333

Details and patient eligibility

About

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.

Full description

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

Enrollment: 126 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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126 participants in 2 patient groups, including a placebo group

Shi-Bi-Lin

Active Comparator group

Description:

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).

Treatment:

Drug: Shi-Bi-Lin

Placebo

Placebo Comparator group

Description:

The placebo contained brown colored starch resembling the SBL powder

Treatment:

Other: Placebo