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

• Status: Unknown status
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine

Criteria

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