ABSTRACT
Conventional treatments for allergic rhinitis (AR) exhibit insufficiency and long-term use-related side effects. Considering the reported anti-inflammatory and immunoregulatory effects of Bojungikgi-tang (BJIGT), we aimed to assess its efficacy on persistent AR (PAR). Patients with PAR were randomly assigned in a 1:1:1 ratio into high-dose BJIGT, standard-dose BJIGT, and placebo groups, followed by 1-week run-in and 4-week treatment periods. The primary outcome included the mean change in Total Nasal Symptom Score (TNSS), with secondary outcomes encompassing the Korean Allergic Rhinitis-Specific Quality of Life Questionnaire, biomarkers, overall assessment, TNSS by AR pattern identification, and the Sasang constitution. The mean TNSS change was more improved in the BJIGT group than in the placebo group; however, no statistically significant differences were observed. Additional interaction effect analysis revealed a statistically significant improvement in the high-dose BJIGT group compared with the placebo group from weeks 1-2 to weeks 3-4. Regarding secondary outcomes, the BJIGT group exhibited similar or improved results compared with the placebo group, showing no statistically significant differences. No serious adverse effects or clinically significant changes in safety assessments were observed. Given that this study validated clinical improvement and safety, it serves as potential groundwork for pertinent future studies.
ABSTRACT
Background: Allergic rhinitis (AR) is a common disease, and conventional medications are often insufficient for treatment. Bojungikgi-tang (BJIGT) is an herbal medicine widely used in traditional medicine and has anti-inflammatory and immunoregulatory effects. We hypothesize that BJIGT would improve nasal symptoms in patients with persistent AR (PAR). Methods: This is a randomized, double-blind, placebo-controlled, phase II trial. A total of 105 patients, identified with perennial allergens, with a history of PAR and a mean total nasal symptom score (TNSS) ≥ 5 during the run-in period will be recruited from Daejeon Korean Medicine Hospital. Participants will be randomly assigned to a high-dose BJIGT group, standard-dose BJIGT group, or control group (placebo) in a 1 : 1 : 1 allocation ratio after a week run-in period. The treatment medication will be taken three times per day for 4 weeks. The primary outcome measure is the mean change in the TNSS before and after medication. The secondary outcome measures include the Korean Allergic Rhinitis-Specific Quality of Life Questionnaire, total IgE and eosinophil count, overall assessment of AR, pattern identification questionnaire for AR, and Sasang constitution. Discussion. The aim of this study is to investigate the efficacy and safety of BJIGT in the treatment of PAR and to determine the suitable dosage of BJIGT. Therefore, we planned a randomized, controlled, phase II trial of two different doses of BJIGT compared with placebo, and the results of this study are expected to provide evidence for the use of BJIGT as a treatment of PAR. Trial Registration. The National Clinical Trial Registry Clinical Research Information Service, CRIS, KCT0006616, https://cris.nih.go.kr/cris/search/detailSearch.do/20706.
ABSTRACT
Arterial wall viscoelasticity is likely to be a good diagnostic indicator of vascular disease, but only a few studies on the assessment of wall viscosity have been performed. Artery phantoms are manufactured using polydimethylsiloxane (PDMS) to simulate the viscoelastic characteristics of the artery wall, which depends on the wall tissue composition and progression of atherosclerosis. The viscoelastic property of PDMS is controlled by adjusting the mixture ratio of resin, curing agent, and pure silicone oil. The pressure and diameter waveforms of the artery phantom were measured to estimate the wall viscoelasticity. Elasticity is assessed using the diameter distention over the pulse pressure, and the viscosity is evaluated using the energy dissipation ratio of the pressure-diameter curve and the phase lag between the first harmonics of pressure and diameter waveforms (DP1). PDMS phantoms with resin-to-curing-agent ratios of 20:1 and 25:1 show viscoelastic characteristics similar to those of young and old human carotid arteries, respectively. Adding pure silicone oil further softens the silicone elastomer while decreasing its viscosity. The phantoms with 10:1:5 and 10:1:8 mixture ratios (resin: curing agent: silicone oil) show elasticity similar to that of the 20:1:0 and 25:1:0 ratios, respectively, albeit with a noticeable decrease in viscosity. An abrupt decrease in the phase lag (DP1) was found near the interface of the arterial phantom with different mixture ratios (20:1:0 and 10:1:5), while the change in diameter distension was negligible. DP1 may be a new index to differentiate wall tissues with similar elastic properties but different viscous behavior. The pressure diameter curve and DP1 of the phantom simulating the atherosclerosis wall can be compared with patient data and applied to clinical evaluation of plaque viscoelasticity. Computational analysis of arterial wall motion was performed using a standard linear viscoelastic model. The model parameters were determined from the measured pressure-diameter relationship, and the arterial wall motions of phantoms with different viscoelastic properties were successfully simulated. The computational model may provide a useful insight into the changes of arterial viscoelasticity caused by pathogenic wall degeneration.
