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

Primary Purpose

Patch,Chinese Herb, Moxibustion, Allergic Rhinitis

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Sanfu herbal patch
Sanfu moxibustion
Sanfu herbal patch and moxibustion
Sponsored by
Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patch,Chinese Herb

Eligibility Criteria

5 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hubei university of TCMRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Sanfu herbal patch

Sanfu moxibustion

Sanfu herbal patch and Sanfu moxibustion

controlled

Arm 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

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

use herbal patch and moxibustion together in hot dog days

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
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.

Full Information

First Posted
October 18, 2015
Last Updated
March 22, 2018
Sponsor
Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibust
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1. Study Identification

Unique Protocol Identification Number
NCT02580682
Brief Title
Sanfu Herbal Patch and Sanfu Moxibustion for Persistent Allergic Rhinitis: a Controlled Clinical Trial
Official Title
San-fu Herbal Patch and San-fu Moxibustion for Persistent Allergic Rhinitis: a Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patch,Chinese Herb, Moxibustion, Allergic Rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
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
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sanfu herbal patch
Arm Type
Experimental
Arm 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
Arm Title
Sanfu moxibustion
Arm Type
Experimental
Arm Description
use moxibustion in hot dog days of summer,and adopting the indirect moxibustion box method at the bilateral BL13, BL20, and BL23 acupoints
Arm Title
Sanfu herbal patch and Sanfu moxibustion
Arm Type
Experimental
Arm Description
use herbal patch and moxibustion together in hot dog days
Arm Title
controlled
Arm Type
No Intervention
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Sanfu herbal patch
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Sanfu moxibustion
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Sanfu herbal patch and moxibustion
Intervention Description
use Sanfu moxibustion followed by Sanfu herbal patch
Primary Outcome Measure Information:
Title
Total Nasal Symptom Score(TNSS)
Description
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
Time Frame
three years
Secondary Outcome Measure Information:
Title
visual analogue scale (VAS)
Description
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
Time Frame
three years
Title
Rhinitis Quality of Life Questionnaire (RQLQ)
Description
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.
Time Frame
three years
Title
36-item Short-Form Health Survey (SF-36)
Description
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.
Time Frame
three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Patients recruited to this study must meet the following inclusion criteria: Males or females aged between 5 and 60 years. 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. 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 The course of the disease is more than 1 year. Voluntary signing of an informed consent form. No current participation in any other clinical trials. Exclusion criteria Patients with any of the following conditions will be excluded: 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. Patients with other allergic diseases, such as allergic asthma. 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 Patients who received immune therapy or systematic hormonotherapy in the past 1 year. Pregnant women, lactating women, or women preparing for pregnancy in 2 years. Patients with serious medical disorders such as congenital heart disease, severe nephropathy, mental diseases, and infectious diseases including tuberculosis, hepatitis, and AIDS.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fengxia Liang, Doctor
Phone
+86 18971371818
Email
315938821@qq.com
Facility Information:
Facility Name
Hubei university of TCM
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fengxia Liang, Doctor
Phone
+86 18971371818
Email
315938821@qq.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing 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.

Learn more about this trial

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

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