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

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

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

Study Overview

• Status: Unknown
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Drug: Sanfujiu; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 453
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Guangdong Provincial Hospital of Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Sanfujiu; Other Names: Sanfu-moxibustion
Placebo Comparator: 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.	Drug: Placebo; The placebo ointment is composed of flour, buckwheat flour, food colorants and water, resulting in an ointment similar in appearance to the Sanfujiu ointment.; Other Names: Placebo ointment
No Intervention: waiting list; No intervention in the first year. Accept Sanfujiu in the second and the third years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Investigators: Principal Investigator: Chuanjian Lu, Doctor, Guangdong Provincial Hospital of Traditional Chinese Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: July 7, 2014
• First Submitted That Met QC Criteria: July 16, 2014
• First Posted (Estimate): July 17, 2014

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 19, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: SPAR