Allergic Rhinitis, Asthma
Conditions
Brief summary
This randomized controlled study aimed to evaluate the efficacy and safety of acupuncture therapy on persistent allergic rhinitis patients complicated with asthma.
Interventions
DEVICEAcupuncture
In the acupuncture treatment group, 10 acupuncture points (bilateral LI4, TE23, ST36, unilateral EHN-1, GV23, LI20 and LI4) will be inserted with 0.20 mm in diameter x 30 mm in length disposal needles. The needle will be inserted to a depth of 10 - 30 mm, according to the points selected. The participating acupuncture doctors will manually manipulate the acupuncture needles with de-qi sensation and maintain the needles for 10 minutes with two times of manual stimulation, at the beginning and at the end.
Sponsors
Jun-Yong Choi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Suffering from persistent Allergic rhinitis (PAR; nasal obstruction, rhinorrhoea, sneezing and nasal itching) symptoms for more than 4 days/week, and greater than 4 consecutive weeks. 2. Moderate-severe symptoms according to Allergic rhinitis and its impact on asthma (ARIA) criteria. 3. Positive reaction for more than or equal to one respiratory allergen (SPT or MAST) 4. Stable asthma symptoms with diagnosis of Asthma by respiratory or allergic disease specialist. 5. No changes in asthma or allergic rhinitis drugs for the past month 6. Aged greater than or equal to 18 years, either sex. 7. No problem with expression of opinion 8. Provided with written consent 9. No other disease except allergic rhinitis or asthma which could affect the disease.
Exclusion criteria
1. Having experience using ventilator due to exacerbation of asthma symptoms within six months. 2. Experience of acute respiratory tract infection treated with antibiotics within 14 days 3. Having anatomical occlusion or deformation in nasal cavity. 4. Signs of infection in chest X-ray or having active respiratory disease except asthma 5. Below or equal to 4 on Total nasal symptom score (TNSS) in the latest week. 6. Received drugs affecting directly to allergic rhinitis such as H1-antihistamines, decongestants (nasal, oral or ocular), corticosteroids within 14 days. 7. Received following treatments for allergic rhinitis or asthma within six months ; Traditional Korean medicine interventions such as acupuncture, moxibustion, cupping therapy and herbal medication inhalation or CAM including homeopathy. 8. Received herbal medication for allergic rhinitis or asthma within 14 days. 9. Pregnant, planning the pregnancy or breast-feeding 10. Tuberculosis, hepatitis or more than 2 x normal limit of serum creatinine, aspartate aminotransferase/alanine aminotransferase (AST/ALT). 11. Skin lesion on acupoint or other systemic disease insufficient for acupuncture. 12. Night-shift workers staying up all night 13. Who cannot participate clinical trial properly.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Nasal Symptom Score (TNSS) | Change from Baseline TNSS Score at 4 Weeks after Randomization |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life Questionnaire for adult Korean Asthmatics (QLQAKA) | Change from Baseline at 2 Weeks after Randomization (Both Groups), Change from Baseline at 4 Weeks after Randomization (Both Groups), Change from Baseline at 8 Weeks after Randomization (Active Group Only) |
| Visual Analogue Scale | Change from Baseline at 2 Weeks after Randomization (Both Groups), Change from Baseline at 4 Weeks after Randomization (Both Groups), Change from Baseline at 8 Weeks after Randomization (Active Group Only) |
| Rhinitis Quality of Life Questionnaire (RQLQ) | Change from Baseline at 2 Weeks after Randomization (Both Groups), Change from Baseline at 4 Weeks after Randomization (Both Groups), Change from Baseline at 8 Weeks after Randomization (Active Group Only) |
| Euro Quality of Life-5 Dimention Questionnaire (EQ-5D) | Baseline, four weeks after randomization |
| Total Nasal Symptom Score (TNSS) | Change from Baseline at 2 Weeks after Randomization (Both Groups), Change from Baseline at 8 Weeks after Randomization (Active Group Only) |
| Pulmonary function test (PFT) | Baseline, four weeks after randomization (both groups) |
Countries
South Korea
Contacts
Primary ContactMinjoo Kang, BcS
Outcome results
None listed