Acupuncture for Rhinitis Complicated With Asthma

Not Applicable

• Conditions: Asthma; Allergic Rhinitis
• Interventions: Device: Acupuncture

• Registration Number: NCT02033252
• Lead Sponsor: Jun-Yong Choi

Brief Summary

This randomized controlled study aimed to evaluate the efficacy and safety of acupuncture therapy on persistent allergic rhinitis patients complicated with asthma.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-07
• Study First Submitted QC: 2014-01-09
• Study First Posted: 2014-01-10
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-31
• Last Update Posted: 2015-09-02
• Primary Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture	Acupuncture	A series of acupuncture sessions within four weeks from the baseline with concurrent conventional medications for asthma

Primary Outcome Measures

Name	Time	Method
Total Nasal Symptom Score (TNSS)	Change from Baseline TNSS Score at 4 Weeks after Randomization

Secondary Outcome Measures

Name	Time	Method
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)
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)
Pulmonary function test (PFT)	Baseline, four weeks after randomization (both groups)
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)

Trial Locations

Locations (1)

National Clinical Research Center, Korean Medicine Hospital, Pusan National University; 🇰🇷 Yangsan, Kyungsangnamdo, Korea, Republic of