Effectivness and Safety of Acupuncture Combined With Moxibustion for Allergic Rhinitis

Phase 2

Completed

• Conditions: Rhinitis, Allergic, Perennial
• Interventions: Other: acupuncture combined moxibustion; Drug: Loratadine

• Registration Number: NCT02339714
• Lead Sponsor: Zhao Hong

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-13
• Study First Submitted QC: 2015-01-14
• Study First Posted: 2015-01-15
• Study Start: 2015-03
• Primary Completion: 2016-05
• Study Completion: 2018-06
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-17
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture combined moxibustion	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.
loratadine	Loratadine	Loratadine taken orally, 10mg/day in the morning

Primary Outcome Measures

Name	Time	Method
Change from baseline in the weekly average of the participants' total nasal symptom score (TNSS) at the 4th week.	at the 4th week

Secondary Outcome Measures

Name	Time	Method
Change from baseline in the weekly average of the participants' total non-nasal symptom score (TNNSS) at the 4th week	at the 4th week
Change from baseline in Quality of life questionnaire (QLQ) at the 4th week	at the 4th Week

Trial Locations

Locations (3)

Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, Beijing, China

Mentougou Hospital of TCM; 🇨🇳 Beijing, Beijing, China

Guang'anmen Hospital, China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, Beijing, China