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

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

Detailed Description
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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.

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

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: Sanfujiu
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sanfujiu<br>Formula for Sanfujiu: Huangjiezi; Xixin; Yanhusuo; and so on Acupoint for Sanfujiu: Different ten acupoints determined according to Chinese medicine theory for each time. Timepoint: Five times of 3 years at Sanfu Point application: The patients will be treated with herbal cake-separated moxibustion on acupoints and lasted 60 minutes each time. | Drug: Sanfujiu<br> <br> * Other names: Sanfu-moxibustion;|
| Placebo Comparator: placebo<br>Formula for placebo: Fuxiaomai; and so on. the appearance is similar as drugs of Sanfujiu Acupoint for placebo: Ten acupoints determined according to Chinese medicine theory are the same as Sanfujiu group of each timepoint . Timepoint: Five times per year for 3 years. Point application: The patients will be treated with placebo on acupoints and lasted 60 minutes each time. | Drug: Placebo<br>* The placebo ointment is composed of flour, buckwheat flour, food colorants and water, resulting in an ointment similar in appearance to the Sanfujiu ointment.<br>* Other names: Placebo ointment;|
| No Intervention: waiting list<br>No intervention in the first year. Accept Sanfujiu in the second and the third years. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in total nasal symptom score at 12 months |  | 12 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Rhinitis Quality of Life Questionnaire at 12 months |  | 12 months after treatment | 
| 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 | 
| The number of days of allergic rhinitis attack |  | 12 months after treatment | 
| The quantity of conventional relief medication used |  | 12 months after treatment |