Thread Embedding Acupuncture For Rhinitis Allergy

University of Medicine and Pharmacy at Ho Chi Minh City

Status: Completed

Conditions: Rhinitis Allergic

Treatments: Other: Thread embedding acupuncture; Other: Standal treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06858137

2466/ĐHYD-HDDD

Details and patient eligibility

About

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

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Those not participating in any other clinical trial
• Those who provide written informed consent
• Those with typical symptoms of AR, rhinorrhea, sneezing, nasal obstruction, and pruritus. These symptoms should last at least one hour most day since last two week.

Exclusion criteria

• Pregnancy, lactation, or recent childbirth within the past 6 months.
• Those were receiving immune therapy
• Those with other allergic diseases such as bronchial asthma or allergic purpura
• Those with nasal polyposis
• Those with heterologous protein allergy
• Those with other disorders such as AIDS, vascular malformation, hypertension, hematologic, diseases, diabetes mellitus, malignant tumor, or mental disorders.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

Thread embedding acupuncture + fluticasone propionate spray

Experimental group

Description:

Thread embedding acupuncture (TEA) every two weeks in four weeks (two sessions). Combined with fluticasone propionate spray (INCS) when needed in four weeks and lifestyle changing

Treatment:

Other: Standal treatment

Other: Thread embedding acupuncture

fluticasone propionate spray

Active Comparator group

Description:

Fluticasone propionate when needed in four weeks combined lifestyle changing

Treatment:

Other: Standal treatment