NCT03282630

The Effects of Sphenopalatine Ganglion Acupuncture in Patients With Seasonal Allergic Rhinitis

The Effects of Sphenopalatine Ganglion Acupuncture in Patients With Seasonal Allergic Rhinitis: A Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Beijing Tongren Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Sphenopalatine ganglion (SPG)-acupuncture has been shown to exhibit distinct effects in treatment of nasal inflammatory disease. Investigators aimed to assess the effects of SPG acupuncture in patients with seasonal allergic rhinitis. The randomized, double-blind, controlled clinical trial enrolled participants with seasonal allergic rhinitis. Participants will be randomly assigned to either active SPG-acupuncture group or sham-acupuncture group. All participants will be provided four times of acupuncture in 4 weeks, and then follow-up of 4 week. Primary trial outcomes are change in symptoms and change in need for medication. The primary outcomes will be measured in baseline, week1, week2, week3, week4, week 6 and week 8. Secondary outcomes include the changes in nasal patency (nasal airway resistance and nasal cavity volume), exhaled nasal nitric oxide.The investigators also evaluate change in neuropeptides (substance P, vasoactive intestinal peptide,neuropeptide Y) and inflammatory cytokines (interleukin(IL)-4, IL-5, IL-8, IL-17a, IL-22, IL-25, interferon-γ, tumor necrosis factor-α, transforming growth factor(TGF)-β1, TGF-β2, TGF-β3,Chemokine, Eotaxin) in nasal secretions as secondary outcomes. The secondary outcomes will be measured in baseline, week1, week4 and week 8.

Conditions

• Patients

Interventions

Type	Name	Description
PROCEDURE	Sphenopalatine ganglion acupuncture	* active sphenopalatine ganglion acupuncture The acupuncture point was selected in the sphenopalatine ganglion (unilateral side). The acupuncture needle was inserted from the lower border of the zygomatic arch, slightly posterior to the suture protuberance between the zygomatic process * sham sphenopalatine ganglion acupuncture The acupuncture point was selected same to the sphenopalatine ganglion. But the needle was inserted at the selected acupuncture site to a depth of only 2-3cm, and the procedure of rotating, twirling and thrusting the needle was repeated, in order to blind the subject to the sham treatment.

Timeline

• Start date: 2016-01-16
• Primary completion: 2017-01-16
• Completion: 2017-02-20
• First posted: 2017-09-14
• Last updated: 2017-09-14

Locations

1 site across 1 country: China