Clinical trial NCT02580682: Sanfu Herbal Patch and Sanfu Moxibustion for Persistent Allergic Rhinitis: a Controlled Clinical Trial
Official title: San-fu Herbal Patch and San-fu Moxibustion for Persistent Allergic Rhinitis: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Patch,Chinese Herb
Moxibustion
Allergic Rhinitis
Lead sponsor: Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibust
Sponsor class: OTHER
First posted: 2015-10-20
Enrollment: 200
Sex: ALL
Minimum age (years): 5
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To observe the efficacy of Sanfu herbal patch and Sanfu moxibustion on persistent allergic rhinitis,and comparing the differences between the combination of these 2 methods with each method alone.


Eligibility criteria: Inclusion criteria

Patients recruited to this study must meet the following inclusion criteria:

1. Males or females aged between 5 and 60 years.
2. Each PAR patient must be diagnosed by an otolaryngologist using the following diagnostic criteria: major symptoms of paroxysm rhinocnesmus, continuous sneezing, nasal obstruction, and significant quantities of clear and thin nasal mucus, accompanied by symptoms of hyposmia and itching of the eyes and throat. These symptoms should last for or add up to 1 hour a day. The attacks should occur for more than 4 weeks and at last for at least 4 days each week.
3. One of 2 laboratory results is positive: skin prick test or serum high circulating levels of allergen-specific IgE antibody detected by a specific blood test for allergy called a radioallergosorbent (RAST) test
4. The course of the disease is more than 1 year.
5. Voluntary signing of an informed consent form.
6. No current participation in any other clinical trials. Exclusion criteria

Patients with any of the following conditions will be excluded:

1. Allergies to the herbal medicines, a moxa smoke or adhesive tape applied in this study, and the skin at the specific acupoint has physical scars or breakage.
2. Patients with other allergic diseases, such as allergic asthma.
3. Patients who received acupuncture and moxibustion treatment, Chinese herbal medicine, nasal inhalation of herbal medicine, physical therapy or other external treatment for AR within the last 4 weeks
4. Patients who received immune therapy or systematic hormonotherapy in the past 1 year.
5. Pregnant women, lactating women, or women preparing for pregnancy in 2 years.
6. Patients with serious medical disorders such as congenital heart disease, severe nephropathy, mental diseases, and infectious diseases including tuberculosis, hepatitis, and AIDS.

Primary outcomes:
measure: Total Nasal Symptom Score(TNSS)
timeFrame: three years
Secondary outcomes:
measure: visual analogue scale (VAS)
timeFrame: three years
measure: Rhinitis Quality of Life Questionnaire (RQLQ)
timeFrame: three years
measure: 36-item Short-Form Health Survey (SF-36)
timeFrame: three years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Hubei university of TCM
state: Hubei
Study officials:
References: