Clinical trial NCT02339714: Effectivness and Safety of Acupuncture Combined With Moxibustion for Allergic Rhinitis
Official title: Effect Comparison of Acupuncture Combined With Moxibustion and Loratadine for Perennial Allergic Rhinitis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rhinitis, Allergic, Perennial
Keywords: allergic rhinitis
acupuncture
moxibustion
efficacy
safety
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: China Academy of Chinese Medical Sciences
name: Beijing Municipal Science & Technology Commission
First posted: 2015-01-15
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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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Primary outcomes:
measure: Change from baseline in the weekly average of the participants' total nasal symptom score (TNSS) at the 4th week.
timeFrame: at the 4th week
Secondary outcomes:
measure: Change from baseline in the weekly average of the participants' total non-nasal symptom score (TNNSS) at the 4th week
timeFrame: at the 4th week
measure: Change from baseline in Quality of life questionnaire (QLQ) at the 4th week
timeFrame: at the 4th Week
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital, China Academy of Chinese Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Mentougou Hospital of TCM
state: Beijing
Study officials:
affiliation: Vice President of China Academy of Chinese Medical Sciences
name: Liu Baoyan, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sun Y, Zhao H, Ye Y, Nie W, Bai W, Liu J, Li S, Wang F, Han M, He L. Efficacy and safety of using a warming needle for persistent allergic rhinitis: study protocol for a randomized controlled trial. Trials. 2016 Jun 30;17(1):305. doi: 10.1186/s13063-016-1432-z.