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

Phase 3

• Conditions: Allergic Rhinitis
• Interventions: Drug: Sanfujiu; Drug: Placebo

• Registration Number: NCT02192645
• Lead Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-07
• Study First Submitted QC: 2014-07-16
• Study First Posted: 2014-07-17
• Status Verified: 2017-07
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Last Update Submitted: 2017-07-19
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 453

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sanfujiu	Sanfujiu	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.
placebo	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in total nasal symptom score at 12 months	12 months after treatment

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Rhinitis Quality of Life Questionnaire at 12 months	12 months after treatment
Responder rate of Rhinitis Quality of Life Questionnaire	12 months after treatment	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
The quantity of conventional relief medication used	12 months after treatment
The number of days of allergic rhinitis attack	12 months after treatment

Trial Locations

Locations (1)

Guangdong Provincial Hospital of Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China