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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02339714
Other study ID # AAMH001
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 2015
Est. completion date June 2018

Study information

Verified date July 2018
Source China Academy of Chinese Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 98
Est. completion date June 2018
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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.

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

Study Design


Intervention

Other:
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.
Drug:
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.

Locations

Country Name City State
China Guang'anmen Hospital, China Academy of Chinese Medical Sciences Beijing Beijing
China Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Beijing Beijing
China Mentougou Hospital of TCM Beijing Beijing

Sponsors (3)

Lead Sponsor Collaborator
Zhao Hong Beijing Municipal Science & Technology Commission, China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in the weekly average of the participants' total nasal symptom score (TNSS) at the 4th week. at the 4th week
Secondary Change from baseline in the weekly average of the participants' total non-nasal symptom score (TNNSS) at the 4th week at the 4th week
Secondary Change from baseline in Quality of life questionnaire (QLQ) at the 4th week at the 4th Week
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