Rhinitis Allergic
Conditions
Keywords
Rhinitis allergic, thread embedding acupuncture, traditional medicine
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.
Interventions
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.
OTHERStandal 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.
Sponsors
University of Medicine and Pharmacy at Ho Chi Minh City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The physician responsible for administering the treatments will be aware of the group assignments but remain uninvolved in the evaluation of outcomes and subsequent data analysis. Those responsible for outcome assessment and data analysis will be kept blinded to the treatment assignments.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in nasal symtoms | Assessments conducted at randomization and after each intervention week throughout the first two-week period (Week 0, Week 1, Week 2), then Week 8. | Visual analogue scale (VAS) consists of a 100mm long line, ranging from no troublesome at all to very troublesome AR patients mark a point that best corresponds to the severity of their symptoms since a week before or current status of disease control. Participants will mark the position on the scale that corresponds to their current. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in quality of life | Assessments conducted at randomization and after two-week period (Week 0, Week 2, Week 6, Week 8) | Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) has 28 questions in seven domains (activity limitation, sleep problems, nose symptoms, eye symptoms, non-nose/eye symptoms, practical problems, and emotional function). Participants will recall to their rhinitis allergy symptoms for last two weeks to respond to each question on a seven-point scale (0 = not impaired at all; 6 = severely impaired). |
| Changes in relief medication | Assessments conducted at randomization and after two-week period (Week 0, Week 2, Week 4, Week 6, Week 8) | Relief medication score including the INCS dosage per day and days per week. |
| Proportion of intervention-related adverse effects | Up to eight weeks | For Thread embedding acupuncture, expected AEs encompass local discomfort, post-treatment elevation in body temperature, local hematoma or subcutaneous hemorrhage, local swelling, local induration, local pain, local redness, infection, abscess, pruritus, and anaphylaxis. Additionally, any unexpected AEs associated with these procedures will also be documented and monitored. |
Countries
Vietnam
Outcome results
None listed