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

NCT ID: NCT02192645

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 453 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2017-07-31

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.

Conditions

Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Sanfujiu

Intervention Type: DRUG

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

The placebo ointment is composed of flour, buckwheat flour, food colorants and water, resulting in an ointment similar in appearance to the Sanfujiu ointment.

waiting list

No intervention in the first year. Accept Sanfujiu in the second and the third years.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sanfujiu

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Sanfu-moxibustion; Placebo ointment

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Provincial Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Chuanjian Lu

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chuanjian Lu, Doctor

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial Hospital of Traditional Chinese Medicine

Locations

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 26300945 (View on PubMed)

Other Identifiers

SPAR

Identifier Type: -

Identifier Source: org_study_id