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

NCT02192645 | Unknown Phase 3 DMC

• 1 other identifier: SPAR
• Study Type: interventional
• Target: 453
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Change from baseline in total nasal symptom score at 12 months

  12 months after treatment

Secondary Outcomes (4)

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

  12 months after treatment

• Responder rate of Rhinitis Quality of Life Questionnaire

  12 months after treatment

• The number of days of allergic rhinitis attack

  12 months after treatment

• The quantity of conventional relief medication used

  12 months after treatment

Study Arms (3)

Sanfujiu

EXPERIMENTAL

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.

Drug: Sanfujiu

placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

waiting list

NO INTERVENTION

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

Interventions

Sanfujiu DRUG

Also known as: Sanfu-moxibustion

Sanfujiu

Placebo DRUG

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

Also known as: Placebo ointment

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangdong Provincial Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, 510120, China

Location

Related Publications (1)

• 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.

  PMID: 26300945 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

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

Study Officials

• Chuanjian Lu, Doctor

  Guangdong Provincial Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: July 17, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

CN (1)