NCT06858137

Thread Embedding Acupuncture For Rhinitis Allergy

Efficacy and Safety of Thread Embedding Acupuncture for Rhinitis Allergy: Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Rhinitis allergy is chronic non-communicable disease with a rapid increase in the number of patients since 1990s. Rhinitis allergy is one of the risk factors for various chronic others including asthma, sinusitis, otitis media, as well as some conditions sleep disorders, emotional disorders related. There are numerous pharmacological and non-pharmacological therapies that have been employed in management of these condition. Among them, thread embedding acupuncture (TEA) has been a widely used and established method for various chronic diseases, demonstrating its effectiveness, safety, and convenience. Several studies have shown a significant increase in treatment when combining TEA with pharmacological or other acupuncture therapies. However, there is currently no substantial data on the application of TEA for rhinitis allergy treatment. This study is conducted to assess the efficacy and safety of combining TEA with inhaled corticosteroid (INCS) compared with ICS monotherapy in rhinitis allergy

Detailed description

Eligible participants with rhinitis allergy, defined according to the criteria set by Allergic Rhinitis and its Impact on Asthma (ARIA) 2008, will be enrolled and subsequently randomized into two groups: the intervention group (TEA + INCS group) and the control group (INCS), with a 1:1 allocation ratio. In both groups, the intervention duration is four weeks, with inhaled corticosteroid (INCS) - fluticasone propionate used for four weeks in required and life style changing. For the intervention group, thread embedding acupuncture (TEA) therapy will be added every two weeks, totaling two sessions during the four-week period. Data regarding number of symptoms, BMI, Visual Analogue Scale (VAS), Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), Relief medication score and adverse effects will be recorded immediately following randomization and weekly thereafter over the eight-week duration.

Conditions

• Rhinitis Allergic

Interventions

Type	Name	Description
OTHER	Thread embedding acupuncture	Thread embedding acupuncture is performed every two weeks in four weeks using a single Polydioxaone thread. Needles have a gauge size of 30G, a shaft length of 26mm, folded in half, and are applied to nine acupoints, including Yintang (EX-HN3), Yingxiang (LI20) on both sides of the body. Needles with a gauge size of 29G, a shaft length of 30mm, and a thread length of 50mm, folded in half, are used for three acupoints, which included Hegu (LI4), Zusanli (ST36), Feishu (BL13), on both sides of the body. After the thread being inserted into the body, the needle will be withdrawn immediately.
OTHER	Standal treatment	Inhaled corticosteroid spray - fluticasone propionate patients were permitted to use Fluticasone propionate 1 or 2 sprays (50 mcg/spray) in each nostril once a day as needed in four weeks and participants must change life style attaches including smoke and traffic pollution avoidant, preventing pets going into the bedroom, washing clothes.

Timeline

• Start date: 2024-12-15
• Primary completion: 2025-04-15
• Completion: 2025-07-31
• First posted: 2025-03-05
• Last updated: 2025-09-04

Locations

1 site across 1 country: Vietnam