Sanfu Herbal Patch and Sanfu Moxibustion for Persistent Allergic Rhinitis: a Controlled Clinical Trial

Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibust

Status and phase: Unknown; Phase 2

Conditions: Moxibustion; Allergic Rhinitis; Patch,Chinese Herb

Treatments: Drug: Sanfu herbal patch; Drug: Sanfu herbal patch and moxibustion; Drug: Sanfu moxibustion

Study type: Interventional

Funder types: Other

Identifiers

NCT02580682

XTCX2014-SFT

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 5 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 4 patient groups

Sanfu herbal patch

Experimental group

Description:

one kind of acupoint application which used in hot dog days of summer,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 asarum), Bai Jie Zi (Semen Sinapis Albae), and Rou Gui (Cortex Cinnamomi) at a ratio of 2:2:1:1:2:1.The bilateral Feishu (BL13), Pishu (BL20), Shenshu (BL23), Neiguan (PC6), and Guanyuan (CV4) acupoints were selected for treatment

Treatment:

Drug: Sanfu herbal patch

Sanfu moxibustion

Experimental group

Description:

use moxibustion in hot dog days of summer,and adopting the indirect moxibustion box method at the bilateral BL13, BL20, and BL23 acupoints

Treatment:

Drug: Sanfu moxibustion

Sanfu herbal patch and Sanfu moxibustion

Experimental group

Description:

use herbal patch and moxibustion together in hot dog days

Treatment:

Drug: Sanfu herbal patch and moxibustion

controlled

No Intervention group

Description:

patients in this group will not accept herbal patch or moxibustion therapy in these 3 years. After the 3-year experimental period they will be offered corresponding treatments for free as well, so they are in our wait list.