Clinical trial NCT06858137: Thread Embedding Acupuncture for Rhinitis Allergy
Official title: Efficacy and Safety of Thread Embedding Acupuncture for Rhinitis Allergy: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rhinitis Allergic
Keywords: Rhinitis allergic
thread embedding acupuncture
traditional medicine
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in nasal symtoms
timeFrame: Assessments conducted at randomization and after each intervention week throughout the first two-week period (Week 0, Week 1, Week 2), then Week 8.
Secondary outcomes:
measure: Changes in quality of life
timeFrame: Assessments conducted at randomization and after two-week period (Week 0, Week 2, Week 6, Week 8)
measure: Changes in relief medication
timeFrame: Assessments conducted at randomization and after two-week period (Week 0, Week 2, Week 4, Week 6, Week 8)
measure: Proportion of intervention-related adverse effects
timeFrame: Up to eight weeks
Other outcomes:
Locations:
city: Ho Chi Minh
country: Vietnam
facility: University of Medical Center HCMC - Branch no.3
Study officials:
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