Status:
UNKNOWN
The Efficacy and Safety of Sanfujiu on Patients With Persistent Allergic Rhinitis: Randomized Controlled Study
Lead Sponsor:
Guangdong Provincial Hospital of Traditional Chinese Medicine
Conditions:
Allergic Rhinitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether Sanfujiu is effective and safe in the treatment of persistent allergic rhinitis.
Detailed 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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2017
Estimated Enrollment :
453 Patients enrolled
Trial Details
Trial ID
NCT02192645
Start Date
July 1 2014
End Date
July 1 2017
Last Update
July 21 2017
Active Locations (1)
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1
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, China, 510120