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

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

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.

Study Overview

• Status: Unknown
• Conditions: Allergic Rhinitis; Patch,Chinese Herb; Moxibustion
• Intervention / Treatment: Drug: Sanfu herbal patch; Drug: Sanfu moxibustion; Drug: Sanfu herbal patch and moxibustion

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Fengxia Liang, Doctor; Phone Number: +86 18971371818; Email: 315938821@qq.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Hubei university of TCM
      • Contact: Fengxia Liang, Doctor; Phone Number: +86 18971371818; Email: 315938821@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sanfu herbal patch; 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	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.
Experimental: Sanfu moxibustion; use moxibustion in hot dog days of summer,and adopting the indirect moxibustion box method at the bilateral BL13, BL20, and BL23 acupoints	Drug: 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.
Experimental: Sanfu herbal patch and Sanfu moxibustion; use herbal patch and moxibustion together in hot dog days	Drug: Sanfu herbal patch and moxibustion; use Sanfu moxibustion followed by Sanfu herbal patch
No Intervention: controlled; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: October 18, 2015
• First Submitted That Met QC Criteria: October 19, 2015
• First Posted (Estimate): October 20, 2015

Study Record Updates

• Last Update Posted (Actual): March 26, 2018
• Last Update Submitted That Met QC Criteria: March 22, 2018
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: XTCX2014-SFT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: we have recruited approximately sixty patients in tha last year, informations including contacting numbers, medical history, questionnaires and follow-up materials, we have not decided in which way we could share these data.