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Herbal Treatment for Perennial Allergic Rhinitis

Primary Purpose

Perennial Allergic Rhinitis

Status
Completed
Phase
Phase 2
Locations
Hong Kong
Study Type
Interventional
Intervention
Shi-Bi-Lin
Placebo
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perennial Allergic Rhinitis focused on measuring Perennial Allergic rhinitis, Traditional Chinese Medicine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of ENT, Prince of Wales Hospital
  • Department of ENT, Yan Chai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Shi-Bi-Lin

Placebo

Arm 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).

The placebo contained brown colored starch resembling the SBL powder

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
April 4, 2007
Last Updated
November 23, 2009
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT00456755
Brief Title
Herbal Treatment for Perennial Allergic Rhinitis
Official Title
A Herbal Formula (SBL) for the Treatment of Perennial Allergic Rhinitis: A Randomized, Double-blind, Placebo-controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perennial Allergic Rhinitis
Keywords
Perennial Allergic rhinitis, Traditional Chinese Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shi-Bi-Lin
Arm Type
Active Comparator
Arm 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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The placebo contained brown colored starch resembling the SBL powder
Intervention Type
Drug
Intervention Name(s)
Shi-Bi-Lin
Other Intervention Name(s)
Modified from the classic formula Cang-Er-Zi-San.
Intervention Description
4 weeks of treatment, dose of 1 g (two capsules), twice daily
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
4 weeks of colormatched placebo capsules, dose of 1 g (two capsules), twice daily
Primary Outcome Measure Information:
Title
Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4
Description
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.
Time Frame
4 week
Secondary Outcome Measure Information:
Title
Quality of Life (Difference Between Baseline and Week 4)
Description
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).
Time Frame
4 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhao Yu, PhD
Organizational Affiliation
Department of ENT, Prince of Wales Hospital, The Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of ENT, Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Department of ENT, Yan Chai Hospital
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Citations:
PubMed Identifier
7878553
Citation
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Results Reference
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PubMed Identifier
9042070
Citation
Spector SL. Overview of comorbid associations of allergic rhinitis. J Allergy Clin Immunol. 1997 Feb;99(2):S773-80. doi: 10.1016/s0091-6749(97)70126-x.
Results Reference
background
PubMed Identifier
9643741
Citation
Worldwide variation in prevalence of symptoms of asthma, allergic rhinoconjunctivitis, and atopic eczema: ISAAC. The International Study of Asthma and Allergies in Childhood (ISAAC) Steering Committee. Lancet. 1998 Apr 25;351(9111):1225-32.
Results Reference
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PubMed Identifier
11009751
Citation
Nash DB, Sullivan SD, Mackowiak J. Optimizing quality of care and cost effectiveness in treating allergic rhinitis in a managed care setting. Am J Manag Care. 2000 Jan;6(1 Suppl):S3-15; quiz S19-20.
Results Reference
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PubMed Identifier
10077136
Citation
Bielory L, Lupoli K. Herbal interventions in asthma and allergy. J Asthma. 1999;36(1):1-65. doi: 10.3109/02770909909065150.
Results Reference
background
PubMed Identifier
11031328
Citation
Ziment I, Tashkin DP. Alternative medicine for allergy and asthma. J Allergy Clin Immunol. 2000 Oct;106(4):603-14. doi: 10.1067/mai.2000.109432.
Results Reference
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PubMed Identifier
11562075
Citation
Schmolz M, Ottendorfer D, Marz RW, Sieder C. Enhanced resistance to Sendai virus infection in DBA/2J mice with a botanical drug combination (Sinupret). Int Immunopharmacol. 2001 Sep;1(9-10):1841-8. doi: 10.1016/s1567-5769(01)00108-4.
Results Reference
background

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Herbal Treatment for Perennial Allergic Rhinitis

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