Allergic rhinosinusitis Ear, Nose and Throat Vasomotor and allergic rhinitis
Conditions
Interventions
This is a randomised, subject and assessor blinded, sham acupuncture controlled trial.
Participants will receive active or sham acupuncture treatment 3 times per week for 4 weeks and will be followe
Sponsors
Korea Institute of Oriental Medicine (South Korea)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: This trial will be carried out for male or female aged between 18 and 60 with following conditions: 1. Persistent allergic rhinitis with moderate-to-severe or severe symptoms according to the guideline of Allergic Rhinitis and its Impact on Asthma (ARIA) initiative 2. Symptoms of chronic rhinosinusitis by ARIA guideline with the impression of maxillary sinusitis presented on Water's view X-ray
Exclusion criteria
Exclusion criteria: 1. Serious medical conditions in cardiovascular, pulmonary gastrointestinal, genitourinary, neurologic and endocrine system all of which can affect acupuncture treatment 2. Acute/chronic respiratory infections that need systemic antibiotics or anti-tuberculosis agents within 14 days before enrolment 3. Anatomic malformation or history of nose surgery 4. Smoking over 9 cigarettes per day 5. Systemic corticosteroid administration within 6 months before enrolment 6. Any experience of acupuncture or herbal medicine for nasal symptoms within 6 months before enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Daily total nasal symptom score (TNSS) of participants recorded on diaries. TNSS is a summation of four nasal symptom scores graded by 5-point-Likert scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe). These nasal symptoms are nasal obstruction, rhinorrhea, sneezing and pruritus. Weekly average of daily TNSS from 1 week before treatment initiation to 8th week of study will be calculated and analysed. Primary endpoint will be between the duration of 1 week before treatment initiation and the last (4th) week of active or sham acupuncture treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in paranasal X-ray. Timepoints of assessment: baseline, 4 weeks and 8 weeks after baseline 2. Rhinitis Quality of Life Questionnaire (RQLQ) score. Timepoints of assessment: baseline, 4 weeks and 8 weeks after baseline 3. Total non-nasal symptom score (i.e. headache, itching, pain, eye dropping) of which grading method is the same as TNSS. Timepoints of assessment: from -1st week (run-in period) of baseline to the 8th week after baseline. Weekly average of daily total non-nasal symptom score will be observed. | — |
Countries
Korea, South
Outcome results
None listed