Effectivness and Safety of Acupuncture Combined With Moxibustion for Allergic Rhinitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2018-06-30

Brief Summary

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A multi-centre clinical trial done by us（ISRCEN90807007）showed that active acupuncture had significantly greater effect on symptoms of allergic rhinitis than either sham acupuncture or no active treatment. The object of that study was to evaluate the effectiveness and safety of acupuncture for allergic rhinitis. As an explanatory research, acupuncture was defined as the only intervention for treatment group and sham acupuncture, no active treatment as its control groups. Besides, acupuncture combined moxibustion showed better and longer effect than acupuncture on allergic rhinitis patients in our previous pilot study. According to this result, we are taking a pragmatic randomized controlled trial to further evaluate whether acupuncture combined moxibustion is more effective than conventional treatment.

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Detailed Description

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Conditions

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Rhinitis, Allergic, Perennial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Acupuncture combined moxibustion

Acupuncture at Hegu(LI4),Yingxiang(LI20),Chize(LU5),Sibai(ST2), Yintang(EX-HN3),Shangyingxiang(EX-HN8),Shangxing(GV23),Dazhui(Du14). Needle warming moxibustion at Dazhui(Du14). Patients will be treated once per day for 30 min, 3 times in a weeks for 4 weeks.

Group Type EXPERIMENTAL

acupuncture combined moxibustion

Intervention Type OTHER

Points: Hegu(LI4),Yingxiang(LI20),Chize(LU5),Sibai(ST2), Yintang(EX-HN3),Shangyingxiang(EX-HN8),Shangxing(GV23),Dazhui(Du14).

Pierced the skin, needles are inserted 0.5 to 2cm into the acupoints. Each needle are roated until the participants and the practitioner felt de-qi sensation. After that, moxibustion is applied to Dazhui(Du14). A 1cm long moxa cone is putted on the top of the needle at the acupoint, then ignite moxa cone until the cone is burn. The needles are left in place for 30 minutes. once every two days, 3 times in a week for consecutive 4 weeks, 12 times altogether.

loratadine

Loratadine taken orally, 10mg/day in the morning

Group Type ACTIVE_COMPARATOR

Loratadine

Intervention Type DRUG

Loratadine will be taken orally at the dose of 10mg/day in the morning. Each treatment cycle will be given for continuous 4 weeks.

Interventions

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acupuncture combined moxibustion

Points: Hegu(LI4),Yingxiang(LI20),Chize(LU5),Sibai(ST2), Yintang(EX-HN3),Shangyingxiang(EX-HN8),Shangxing(GV23),Dazhui(Du14).

Pierced the skin, needles are inserted 0.5 to 2cm into the acupoints. Each needle are roated until the participants and the practitioner felt de-qi sensation. After that, moxibustion is applied to Dazhui(Du14). A 1cm long moxa cone is putted on the top of the needle at the acupoint, then ignite moxa cone until the cone is burn. The needles are left in place for 30 minutes. once every two days, 3 times in a week for consecutive 4 weeks, 12 times altogether.

Intervention Type OTHER

Loratadine

Loratadine will be taken orally at the dose of 10mg/day in the morning. Each treatment cycle will be given for continuous 4 weeks.

Intervention Type DRUG

Other Intervention Names

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warming needle

Eligibility Criteria

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Inclusion Criteria

Each participant must have a diagnosis of AR by an otolaryngology doctor, according to the criteria listed in "Allergic Rhinitis and its Impact on Asthma" (ARIA 2008) Symptoms that had persisted for more than 4 days per week for more than four consecutive weeks.

At least one of the following rhinitis-associated conditions: nasal obstruction, rhinorrhea, sneezing and nasal itching.

At least one positive result on an allergy skin prick reaction test at screening.

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Exclusion Criteria

Active tuberculosis Autoimmune disorders Severe chronic inflammatory diseases History of anaphylactic reactions Specific immunotherapy \>3 years Simultaneous participation in other clinical trials Serious acute or chronic organic disease or mental disorder Congenital nasal abnormalities Pregnancy or breast feeding Blood coagulation disorder and/or current use of anticoagulants Allergy desensitisation therapy (current, during the past two years, or planned in the next two years) Previous systemically administered corticosteroids, antihistamines, or decongestants in the last 1 months prior to enrollment

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Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No