A Phase 2 interventional study of acupuncture combined moxibustion and Loratadine in Rhinitis, Allergic, Perennial, sponsored by Zhao Hong. Completed at 3 sites in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-07-18.
Sponsored by Zhao Hong · Phase 2, Interventional, and Treatment
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.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 98 is above the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →This is the only study on the registry with Zhao Hong as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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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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.
Other: acupuncture combined moxibustion
Loratadine taken orally, 10mg/day in the morning
Drug: Loratadine
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.
Also known as: warming needle
Loratadine will be taken orally at the dose of 10mg/day in the morning. Each treatment cycle will be given for continuous 4 weeks.
Change from baseline in the weekly average of the participants' total nasal symptom score (TNSS) at the 4th week.
Time frame: at the 4th week
Change from baseline in the weekly average of the participants' total non-nasal symptom score (TNNSS) at the 4th week
Time frame: at the 4th week
Change from baseline in Quality of life questionnaire (QLQ) at the 4th week
Time frame: at the 4th Week
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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