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Completed

NCT Number: NCT00456755

Herbal Treatment for Perennial Allergic Rhinitis

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.

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Key information

Conditions

Perennial Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Perennial

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of ENT, Prince of Wales Hospital, Hong Kong

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shi-Bi-Lin

Drug

4 weeks of treatment, dose of 1 g (two capsules), twice daily

Other names: Modified from the classic formula Cang-Er-Zi-San.

Placebo

Other

4 weeks of colormatched placebo capsules, dose of 1 g (two capsules), twice daily

Primary outcomes

  1. Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4

    Time frame: 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 outcomes

  1. Quality of Life (Difference Between Baseline and Week 4)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Apr 5, 2007
Registry last updated
Jan 6, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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