Overview

This trial is active, not recruiting.

Condition allergic rhinitis
Treatments sanfujiu, placebo
Phase phase 3
Sponsor Guangdong Provincial Hospital of Traditional Chinese Medicine
Start date June 2014
End date June 2017
Trial size 453 participants
Trial identifier NCT02192645, SPAR

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
sanfujiu Sanfu-moxibustion
(Placebo Comparator)
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.
placebo
(No Intervention)
No intervention in the first year. Accept Sanfujiu in the second and the third years.

Primary Outcomes

Measure
Change from baseline in total nasal symptom score at 12 months
time frame: 12 months after treatment

Secondary Outcomes

Measure
Change from baseline in Rhinitis Quality of Life Questionnaire at 12 months
time frame: 12 months after treatment
Responder rate of Rhinitis Quality of Life Questionnaire
time frame: 12 months after treatment
The number of days of allergic rhinitis attack
time frame: 12 months after treatment
The quantity of conventional relief medication used
time frame: 12 months after treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Principal investigator Chuanjian Lu, Doctor
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Guangdong Provincial Hospital of Traditional Chinese Medicine.