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

H

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

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.

Trial contacts and locations

1

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Central trial contact

Fengxia Liang, Doctor

Data sourced from clinicaltrials.gov

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