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

NCT02580682 | Unknown Phase 2 DMC

• 1 other identifier: XTCX2014-SFT
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Patch,Chinese Herb; Moxibustion; Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• visual analogue scale (VAS)

  three years

• Rhinitis Quality of Life Questionnaire (RQLQ)

  three years

• 36-item Short-Form Health Survey (SF-36)

  three years

Study Arms (4)

Sanfu herbal patch

EXPERIMENTAL

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

Sanfu moxibustion

EXPERIMENTAL

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

Sanfu herbal patch and Sanfu moxibustion

EXPERIMENTAL

use herbal patch and moxibustion together in hot dog days

Drug: Sanfu herbal patch and moxibustion

controlled

NO INTERVENTION

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.

Interventions

Sanfu herbal patch DRUG

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 herbal patch

Sanfu moxibustion DRUG

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 moxibustion

Sanfu herbal patch and moxibustion DRUG

use Sanfu moxibustion followed by Sanfu herbal patch

Sanfu herbal patch and Sanfu moxibustion

Eligibility Criteria

• Age: 5 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Hubei university of TCM

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Moxibustion

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics

Central Study Contacts

Fengxia Liang, Doctor

CONTACT

+86 18971371818; 315938821@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2015
• First Posted: October 20, 2015
• Study Start: July 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: March 26, 2018

Record last verified: 2017-04

Locations

CN (1)