Herbal Treatment for Perennial Allergic Rhinitis - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Perennial Allergic Rhinitis
Interventions:	Drug: Shi-Bi-Lin Other: Placebo

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment started at Jan 2004. Patients were recruited as volunteers from the Prince of Wales hospital, the Yan Chai hospital and the Alice Ho Mui Ling Nethersole Hospital specialist clinics.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Confirmed perennial allergic rhinitis and have a positive skin test to house-dust mite, mold antigens and/or animal dander was required. Enter 1-week run-in-period, during which symptom diary was given to each subject for the evaluation of symptoms. Eligible case with total score higher than 4.

Reporting Groups

	Description
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	The placebo contained brown colored starch resembling the SBL powder

Participant Flow: Overall Study

	Shi-Bi-Lin	Placebo
STARTED	63	63
COMPLETED	61	62
NOT COMPLETED	2	1
Lost to Follow-up	2	1

Baseline Characteristics

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Reporting Groups

	Description
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	The placebo contained brown colored starch resembling the SBL powder

Baseline Measures

	Shi-Bi-Lin	Placebo	Total
Number of Participants [units: participants]	63	63	126
Age [units: Year] Mean ± Standard Deviation
Age	41.19 ± 12.38	36.02 ± 11.14	38.60 ± 12.01
Gender [units: Participants]
Female	40	43	83
Male	23	20	43
Region of Enrollment [units: participants]
Hong Kong	63	63	126

Outcome Measures

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1. Primary:

Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4 [ Time Frame: 4 week ]

Show Outcome Measure 1

2. Secondary:

Quality of Life (Difference Between Baseline and Week 4) [ Time Frame: 4 week ]

Show Outcome Measure 2

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Zhao Yu
Organization: Department of Otorhinolaryngology, Head & Neck Surgery, West China Hospital, Sichuan University, China
e-mail: yutzhao@gmail.com

Publications:

Leung R, Ho P. Asthma, allergy, and atopy in three south-east Asian populations. Thorax. 1994 Dec;49(12):1205-10.

Spector SL. Overview of comorbid associations of allergic rhinitis. J Allergy Clin Immunol. 1997 Feb;99(2):S773-80. Review.

[No authors listed] 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.

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.

Bielory L, Lupoli K. Herbal interventions in asthma and allergy. J Asthma. 1999;36(1):1-65. Review.

Ziment I, Tashkin DP. Alternative medicine for allergy and asthma. J Allergy Clin Immunol. 2000 Oct;106(4):603-14. Review.

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.

Responsible Party:	Zhao Yu, Department of Otorhinolaryngology, Head & Neck Surgery, West China Hospital, Sichuan University, Institute of Chinese Medicine, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00456755 History of Changes
Other Study ID Numbers:	ICM/CTS/03/333
Study First Received:	April 4, 2007
Results First Received:	November 23, 2009
Last Updated:	November 23, 2009
Health Authority:	Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee