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

Allergic Rhinitis Clinical Trial

Official title:

San-fu Herbal Patch and San-fu Moxibustion for Persistent Allergic Rhinitis: a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02580682
• Other study ID #: XTCX2014-SFT
• Status: Recruiting
• Phase: Phase 2
• First received: October 18, 2015
• Last updated: March 22, 2018
• Start date: July 2016
• Est. completion date: December 2020

Study information

• Verified date: April 2017
• Source: Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibust
• Contact: Fengxia Liang, Doctor
• Phone: +86 18971371818
• Email: 315938821[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Rhinitis
• Moxibustion
• Patch,Chinese Herb
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• Sanfu 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.
• Sanfu 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.
• Sanfu herbal patch and moxibustion
use Sanfu moxibustion followed by Sanfu herbal patch

Locations

Country	Name	City	State
China	Hubei university of TCM	Wuhan	Hubei

Sponsors (1)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Nasal Symptom Score(TNSS)	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	three years
Secondary	visual analogue scale (VAS)	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	three years
Secondary	Rhinitis Quality of Life Questionnaire (RQLQ)	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.	three years
Secondary	36-item Short-Form Health Survey (SF-36)	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.	three years