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

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ClinicalTrials.gov Identifier: NCT02580682
Recruitment Status : Unknown
Verified April 2017 by Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibust.
Recruitment status was:  Recruiting
First Posted : October 20, 2015
Last Update Posted : March 26, 2018
Sponsor:
Information provided by (Responsible Party):
Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibust

Study Description
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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.

Condition or disease Intervention/treatment Phase
Patch,Chinese Herb Moxibustion Allergic Rhinitis Drug: Sanfu herbal patch Drug: Sanfu moxibustion Drug: Sanfu herbal patch and moxibustion Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Primary Purpose: Treatment
Official Title: San-fu Herbal Patch and San-fu Moxibustion for Persistent Allergic Rhinitis: a Randomized Controlled Clinical Trial
Actual Study Start Date : July 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Total Nasal Symptom Score(TNSS) [ Time Frame: 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 Outcome Measures :
  1. visual analogue scale (VAS) [ Time Frame: 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

  2. Rhinitis Quality of Life Questionnaire (RQLQ) [ Time Frame: 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.

  3. 36-item Short-Form Health Survey (SF-36) [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02580682


Contacts
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Contact: Fengxia Liang, Doctor +86 18971371818 315938821@qq.com

Locations
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China, Hubei
Hubei university of TCM Recruiting
Wuhan, Hubei, China, 430000
Contact: Fengxia Liang, Doctor    +86 18971371818    315938821@qq.com   
Sponsors and Collaborators
Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibust
More Information
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Responsible Party: Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibust
ClinicalTrials.gov Identifier: NCT02580682    
Other Study ID Numbers: XTCX2014-SFT
First Posted: October 20, 2015    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Respiratory Tract Infections
Infections
Nose Diseases
Respiratory Tract Diseases
 Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases