Clinical trial NCT02192645: The Efficacy and Safety of Sanfujiu on Patients With Persistent Allergic Rhinitis: Randomized Controlled Study
Official title: The Efficacy and Safety of Sanfujiu on Patients With Persistent Allergic Rhinitis: Randomized Controlled Study (SPAR Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Allergic Rhinitis
Lead sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2014-07-17
Enrollment: 453
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility 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

Primary outcomes:
measure: Change from baseline in total nasal symptom score at 12 months
timeFrame: 12 months after treatment
Secondary outcomes:
measure: Change from baseline in Rhinitis Quality of Life Questionnaire at 12 months
timeFrame: 12 months after treatment
measure: Responder rate of Rhinitis Quality of Life Questionnaire
timeFrame: 12 months after treatment
measure: The number of days of allergic rhinitis attack
timeFrame: 12 months after treatment
measure: The quantity of conventional relief medication used
timeFrame: 12 months after treatment
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Chinese Medicine
state: Guangdong
Study officials:
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Chuanjian Lu, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen X, Lu C, Stalsby-Lundborg C, Li Y, Li X, Sun J, Ouyang W, Li G, Su G, Lu L, Fu W, Wen Z. Efficacy and Safety of Sanfu Herbal Patch at Acupoints for Persistent Allergic Rhinitis: Study Protocol for a Randomized Controlled Trial. Evid Based Complement Alternat Med. 2015;2015:214846. doi: 10.1155/2015/214846. Epub 2015 Aug 2.