NCT02486159

The Oligonucleotide Chip Analysis for Allergic Rhinitis Treatment in Herbal Plaster and Acupuncture

Completed NA Last updated 11 May 2017

What this trial tests

NA trial testing Herbal plaster (Sanfujiu) in Rhinitis, Allergic in 50 participants. Completed in 1 August 2011.

Timeline

1 September 2009

Primary endpoint
1 June 2011

1 August 2011

Quick facts

Lead sponsor	Chang Gung Memorial Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	50
Start date	1 September 2009
Primary completion	1 June 2011
Estimated completion	1 August 2011

Drugs / interventions tested

• Herbal plaster (Sanfujiu) — full drug profile →
• Acupuncture — full drug profile →

Conditions studied

• Rhinitis, Allergic — all drugs for Rhinitis, Allergic →

Sponsor

Chang Gung Memorial Hospital

Who can join

Adults 18 to 45, any sex, with Rhinitis, Allergic. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change from baseline in Rhinitis Quality of Life Questionnaire (RQLQ) at the third week
  Time frame: T0: before the first acupoint herbal plaster application, T3: the third week, 24 hours after the third acupoint herbal plaster application
  RQLQ, includes 28 questions in 7 categories. The RQLQ was designed to measure the impact of rhinitis on quality of life. It considers that allergic rhinitis patients often are troubled by nasal symptoms, eye symptoms, sleep problems, emotional problems, social issues, and other symptoms.

Sponsor's own description

Using Oligonucleotide Chip Analysis, investigators compared gene expression levels in allergic rhinitis patients before and after a series of acupoint herbal plaster and Acupuncture treatment.

In the first year, Twenty-three participants with persistent allergic rhinitis each received four acupoint herbal plaster treatments, applied using the moxibustion technique, and clinical outcomes were evaluated using the Rhinitis Quality of Life Questionnaire (RQLQ). Peripheral blood samples were analyzed using an ImmunoCAP Phadiatop test, and patients were classified as phadiatop (Ph)-positive or -negative. Microarray results were examined for genes that were differentially expressed between (1) Ph-positive and -negative patients treated with herbal paste; and (2) before and after herbal paste treatment in the Ph-positive patient group.

In the second year, Twenty-seven participants with persistent allergic rhinitis each received four acupoint herbal plaster treatments and 8 courses of acupuncture treatment over 4 weeks in the same time.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Treatment of allergic rhinitis with acupoint herbal plaster: an oligonucleotide chip analysis.
   Shiue HS, Lee YS, Tsai CN, Chang HH. · · 2016 · cited 9× · PMID 27814709 · DOI 10.1186/s12906-016-1418-0