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The Efficacy and Safety of Sanfujiu on Patients With Persistent Allergic Rhinitis: Randomized Controlled Study

Primary Purpose

Allergic Rhinitis

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Sanfujiu

Placebo

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

aged ≥18 with PAR, defined clinically as symptoms being present at least 4 days a week, for at least 4 weeks
Test positive for allergen specific immunoglobulin E . Allergens include: mites (Dermatophagoides pteronyssinus and Dermatophagoides farinae), cockroach (Blatella germanica) and/or house dust
Informed consent
TNSS ≥3

Exclusion Criteria:

Seasonal or chronic instance of other forms of rhinitis (i.e. sinusitis)
Asthma and/or moderate to severe atopic dermatitis
Allergy treatment at present due to asthma, eczema, atopic dermatitis, or other diseases
Nasal structural abnormalities
Severe mental illness, severe chronic respiratory diseases, severe diseases of the cardiovascular system, severe kidney disease, severe liver disease, severe blood system diseases, severe neurological and neuromuscular disease, severe metabolic and endocrine system disease, severe diabetes, immune function (including the application of immunosuppressant or HIV infection to low immune function etc.); The laboratory test indexes more than twice the upper limit of normal reference value or abnormal results that don't fit for the study confirmed by researchers;
Blood coagulation dysfunction or patients are using anticoagulants
Systemic corticosteroids treatment six months before the start of the study, or intranasal corticosteroids 15 days before the start of the study;
Immunotherapy for more than 3 years;
Alternative therapies such as acupuncture, traditional Chinese medicine (TCM) one month before the start of the study,or prepare to use during the study;
Moxibustion therapy half years before the start of the study;
Patients participating other clinical trials;
Prepare to pregnancy, pregnancy or lactation

Sites / Locations

Guangdong Provincial Hospital of Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Sanfujiu

placebo

waiting list

Arm Description

Formula for Sanfujiu: Huangjiezi; Xixin; Yanhusuo; and so on Acupoint for Sanfujiu: Different ten acupoints determined according to Chinese medicine theory for each time. Timepoint: Five times of 3 years at Sanfu Point application: The patients will be treated with herbal cake-separated moxibustion on acupoints and lasted 60 minutes each time.

Formula for placebo: Fuxiaomai; and so on. the appearance is similar as drugs of Sanfujiu Acupoint for placebo: Ten acupoints determined according to Chinese medicine theory are the same as Sanfujiu group of each timepoint . Timepoint: Five times per year for 3 years. Point application: The patients will be treated with placebo on acupoints and lasted 60 minutes each time.

No intervention in the first year. Accept Sanfujiu in the second and the third years.

Outcomes

Primary Outcome Measures

Change from baseline in total nasal symptom score at 12 months

Secondary Outcome Measures

Change from baseline in Rhinitis Quality of Life Questionnaire at 12 months

Responder rate of Rhinitis Quality of Life Questionnaire

Responders to study intervention are defined as patients with a change in Rhinitis Quality of Life Questionnaire score of ≥0.5 between the baseline and 12 months

The number of days of allergic rhinitis attack

The quantity of conventional relief medication used

Full Information

NCT ID

NCT02192645

First Posted

July 7, 2014

Last Updated

July 19, 2017

Sponsor

Guangdong Provincial Hospital of Traditional Chinese Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02192645

Brief Title

The Efficacy and Safety of Sanfujiu on Patients With Persistent Allergic Rhinitis: Randomized Controlled Study

Official Title

The Efficacy and Safety of Sanfujiu on Patients With Persistent Allergic Rhinitis: Randomized Controlled Study (SPAR Study)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Unknown status

Study Start Date

July 2014 (Actual)

Primary Completion Date

July 2017 (Anticipated)

Study Completion Date

July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guangdong Provincial Hospital of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine whether Sanfujiu is effective and safe in the treatment of persistent allergic rhinitis.

Detailed Description

The trial consists of 5 treatment sessions along with a one-year follow-up. This process is then repeated in the second and third years. Eligible participants diagnosed with PAR were randomized at a ratio of 2:2:1 into one of three groups: (a) SHP group; (b) placebo group; or (c) waiting-list group. The waiting-list group will receive no treatment in the first year, but will receive SHP in the following two years. The primary outcome, total nasal symptoms score, is self-assessed at the beginning of each treatment session and during each annual follow-up. Secondary outcomes include the Rhinoconjunctivitis Quality of Life Questionnaire, allergic rhinitis attacks, and relief medications. The trial will be stopped if early termination criteria are met during the interim analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

453 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sanfujiu

Arm Type

Experimental

Arm Description

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

Arm Title

waiting list

Arm Type

No Intervention

Arm Description

No intervention in the first year. Accept Sanfujiu in the second and the third years.

Intervention Type

Drug

Intervention Name(s)

Sanfujiu

Other Intervention Name(s)

Sanfu-moxibustion

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Placebo ointment

Intervention Description

The placebo ointment is composed of flour, buckwheat flour, food colorants and water, resulting in an ointment similar in appearance to the Sanfujiu ointment.

Primary Outcome Measure Information:

Title

Change from baseline in total nasal symptom score at 12 months

Time Frame

12 months after treatment

Secondary Outcome Measure Information:

Title

Change from baseline in Rhinitis Quality of Life Questionnaire at 12 months

Time Frame

12 months after treatment

Title

Responder rate of Rhinitis Quality of Life Questionnaire

Description

Responders to study intervention are defined as patients with a change in Rhinitis Quality of Life Questionnaire score of ≥0.5 between the baseline and 12 months

Time Frame

12 months after treatment

Title

The number of days of allergic rhinitis attack

Time Frame

12 months after treatment

Title

The quantity of conventional relief medication used

Time Frame

12 months after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: aged ≥18 with PAR, defined clinically as symptoms being present at least 4 days a week, for at least 4 weeks Test positive for allergen specific immunoglobulin E . Allergens include: mites (Dermatophagoides pteronyssinus and Dermatophagoides farinae), cockroach (Blatella germanica) and/or house dust Informed consent TNSS ≥3 Exclusion Criteria: Seasonal or chronic instance of other forms of rhinitis (i.e. sinusitis) Asthma and/or moderate to severe atopic dermatitis Allergy treatment at present due to asthma, eczema, atopic dermatitis, or other diseases Nasal structural abnormalities Severe mental illness, severe chronic respiratory diseases, severe diseases of the cardiovascular system, severe kidney disease, severe liver disease, severe blood system diseases, severe neurological and neuromuscular disease, severe metabolic and endocrine system disease, severe diabetes, immune function (including the application of immunosuppressant or HIV infection to low immune function etc.); The laboratory test indexes more than twice the upper limit of normal reference value or abnormal results that don't fit for the study confirmed by researchers; Blood coagulation dysfunction or patients are using anticoagulants Systemic corticosteroids treatment six months before the start of the study, or intranasal corticosteroids 15 days before the start of the study; Immunotherapy for more than 3 years; Alternative therapies such as acupuncture, traditional Chinese medicine (TCM) one month before the start of the study,or prepare to use during the study; Moxibustion therapy half years before the start of the study; Patients participating other clinical trials; Prepare to pregnancy, pregnancy or lactation

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chuanjian Lu, Doctor

Organizational Affiliation

Guangdong Provincial Hospital of Traditional Chinese Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Guangdong Provincial Hospital of Chinese Medicine

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510120

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

26300945

Citation

Chen X, Lu C, Stalsby-Lundborg C, Li Y, Li X, Sun J, Ouyang W, Li G, Su G, Lu L, Fu W, Wen Z. Efficacy and Safety of Sanfu Herbal Patch at Acupoints for Persistent Allergic Rhinitis: Study Protocol for a Randomized Controlled Trial. Evid Based Complement Alternat Med. 2015;2015:214846. doi: 10.1155/2015/214846. Epub 2015 Aug 2.

Results Reference

derived

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The Efficacy and Safety of Sanfujiu on Patients With Persistent Allergic Rhinitis: Randomized Controlled Study

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