Allergic Rhinitis, Moxibustion, Patch,Chinese Herb
Conditions
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.
Interventions
DRUGSanfu herbal patch
The formula of the patch consists of Huang Qi (Astagalus Membranaceus), Fu Zi (Aconiti Lateralis Radix Praeparata), Yan Hu Suo (Rhizoma Corydalis), Xi Xin (Herba As5ari), Bai Jie Zi (Semen Sinapis Albae) and Rou Gui(Cortex Cinnamomi), in a proportion of 2:2:1:1:2:1.
DRUGSanfu moxibustion
Moxibustion is a kind of thermal therapy without any feeling of pain or swell.Moxibustion exerts its therapeutic effect by thermal power and the application of moxa.
DRUGSanfu herbal patch and moxibustion
use Sanfu moxibustion followed by Sanfu herbal patch
Sponsors
Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Since the treatments in this study are visualized, it is not feasible to blind the patients and therapists.Therefore, the outcome assessors will be blinded, they will not participate in the recruitment, study design and the treatment
Eligibility
Sex/Gender
ALL
Age
5 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Nasal Symptom Score(TNSS) | three years | In TNSS, symptoms of nasal congestion , sneezing, nasal itching and rhinorrhea are assessed by scores ranging from 0 to 3. A score of 0 indicates no symptoms, 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity .TNSS is calculated by adding the score for each symptom together |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| visual analogue scale (VAS) | three years | VAS is a 10cm scale to assess the impact of AR on life quality ranging from score of 0 to 10, which stands for no impact to serious impact |
| Rhinitis Quality of Life Questionnaire (RQLQ) | three years | The RQLQ contains 28 questions to evaluate impairment of everyday life caused by symptoms of nose and eyes. Seven dimensions will be assessed, including daily life, sleep, non-nosal/optical symptoms, practical problems, nosal symptoms, optical symptoms and emotion. Every question should be answered by scores: 0 - not trouble, 1 - any trouble at all, 2 - somewhat troubled, 3 - moderately troubled, 4 - quite a bit of trouble, 5 - very troubled, 6 - extremely troubled. |
| 36-item Short-Form Health Survey (SF-36) | three years | SF-36 consists of 36 items categorized as eight dimensions: social functioning (two items), role limitation-emotion (three items), mental health (five items), physical functioning (ten items), role limitation-physical (four items), bodily pain (two items), vitality (four items), general health (five items) and one question of health change in recent one year. |
Countries
China
Contacts
Primary ContactFengxia Liang, Doctor
Outcome results
None listed