The Efficacy and Safety of Sanfujiu on Patients With Persistent Allergic Rhinitis: Randomized Controlled Study

Allergic Rhinitis Clinical Trial

Official title:

The Efficacy and Safety of Sanfujiu on Patients With Persistent Allergic Rhinitis: Randomized Controlled Study (SPAR Study)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02192645
• Other study ID #: SPAR
• Status: Active, not recruiting
• Phase: Phase 3
• First received: July 7, 2014
• Last updated: July 19, 2017
• Start date: July 2014
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether Sanfujiu is effective and safe in the treatment of persistent allergic rhinitis.

Description:

The trial consists of 5 treatment sessions along with a one-year follow-up. This process is then repeated in the second and third years. Eligible participants diagnosed with PAR were randomized at a ratio of 2:2:1 into one of three groups: (a) SHP group; (b) placebo group; or (c) waiting-list group. The waiting-list group will receive no treatment in the first year, but will receive SHP in the following two years. The primary outcome, total nasal symptoms score, is self-assessed at the beginning of each treatment session and during each annual follow-up. Secondary outcomes include the Rhinoconjunctivitis Quality of Life Questionnaire, allergic rhinitis attacks, and relief medications. The trial will be stopped if early termination criteria are met during the interim analysis.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 453
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• aged =18 with PAR, defined clinically as symptoms being present at least 4 days a week, for at least 4 weeks

• Test positive for allergen specific immunoglobulin E . Allergens include: mites (Dermatophagoides pteronyssinus and Dermatophagoides farinae), cockroach (Blatella germanica) and/or house dust

• Informed consent

• TNSS =3

Exclusion Criteria:

• Seasonal or chronic instance of other forms of rhinitis (i.e. sinusitis)

• Asthma and/or moderate to severe atopic dermatitis

• Allergy treatment at present due to asthma, eczema, atopic dermatitis, or other diseases

• Nasal structural abnormalities

• Severe mental illness, severe chronic respiratory diseases, severe diseases of the cardiovascular system, severe kidney disease, severe liver disease, severe blood system diseases, severe neurological and neuromuscular disease, severe metabolic and endocrine system disease, severe diabetes, immune function (including the application of immunosuppressant or HIV infection to low immune function etc.); The laboratory test indexes more than twice the upper limit of normal reference value or abnormal results that don't fit for the study confirmed by researchers;

• Blood coagulation dysfunction or patients are using anticoagulants

• Systemic corticosteroids treatment six months before the start of the study, or intranasal corticosteroids 15 days before the start of the study;

• Immunotherapy for more than 3 years;

• Alternative therapies such as acupuncture, traditional Chinese medicine (TCM) one month before the start of the study,or prepare to use during the study;

• Moxibustion therapy half years before the start of the study;

• Patients participating other clinical trials;

• Prepare to pregnancy, pregnancy or lactation

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• Sanfujiu

• Placebo
The placebo ointment is composed of flour, buckwheat flour, food colorants and water, resulting in an ointment similar in appearance to the Sanfujiu ointment.

Locations

Country	Name	City	State
China	Guangdong Provincial Hospital of Chinese Medicine	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in total nasal symptom score at 12 months		12 months after treatment
Secondary	Change from baseline in Rhinitis Quality of Life Questionnaire at 12 months		12 months after treatment
Secondary	Responder rate of Rhinitis Quality of Life Questionnaire	Responders to study intervention are defined as patients with a change in Rhinitis Quality of Life Questionnaire score of =0.5 between the baseline and 12 months	12 months after treatment
Secondary	The number of days of allergic rhinitis attack		12 months after treatment
Secondary	The quantity of conventional relief medication used		12 months after treatment