Acupuncture for Rhinitis Complicated With Asthma

Asthma Clinical Trial

Official title:

Acupuncture for Persistent Allergic Rhinitis Complicated With Asthma, A Randomized Controlled Pilot Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02033252
• Other study ID #: NCRC-KIM-02
• Status: Recruiting
• Phase: N/A
• First received: January 7, 2014
• Last updated: August 31, 2015
• Start date: January 2014

Study information

• Verified date: August 2015
• Source: Korean Medicine Hospital of Pusan National University
• Contact: Minjoo Kang, BcS
• Phone: 82553605907
• Email: syblkmj[@]hanmail.net
• Is FDA regulated: No
• Health authority: Republic of Korea: Ministry of Food And Drug Safety
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Asthma
• Rhinitis

Intervention

Device:
• Acupuncture
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.

Locations

Country	Name	City	State
Korea, Republic of	National Clinical Research Center, Korean Medicine Hospital, Pusan National University	Yangsan	Kyungsangnamdo

Sponsors (1)

Lead Sponsor	Collaborator
Jun-Yong Choi

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Nasal Symptom Score (TNSS)		Change from Baseline TNSS Score at 4 Weeks after Randomization	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Pulmonary function test (PFT)		Baseline, four weeks after randomization (both groups)	No
Secondary	Euro Quality of Life-5 Dimention Questionnaire (EQ-5D)		Baseline, four weeks after randomization	No
Secondary	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)	No