Clinical trial NCT06709079: Study on the Effect and Mechanism of Aescine Sodium in the Treatment of Allergic Rhinitis
Official title: Study on the Effect and Mechanism of Aescine Sodium in the Treatment of Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Allergic Rhinitis
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Allergic rhinitis is a common chronic non-infectious inflammatory disease of the upper respiratory tract, which affects patients' health, quality of life and work efficiency for a long time. Clinical manifestations are mainly nasal congestion, paroxysmal sneezing, clear watery nasal discharge and nasal itching, among which nasal congestion caused by nasal mucosal edema is the main manifestation of allergic rhinitis. Nasal mucosa has a rich network of arteriovenous anastomosis, and there are many large venous sinuses constitute a spongy structure, with a strong capacity for expansion and contraction, in the onset of allergic rhinitis, the volume of venous sinuses in the nasal mucosa can be rapidly changed, venous sinus expansion and filling can be induced by nasal mucosal congestion and nasal mucosal edema nasal congestion symptoms. Aescine sodium has been widely used in the clinical treatment of local tissue edema and the effect is remarkable, a large number of clinical results have proved that it has a significant anti-inflammatory, anti-edema, enhance the venous tension, improve blood circulation and anti-allergic effect, can be improved through the improvement of the vascular endothelial cell barrier, and enhance the epithelial cells close connection to improve the local edema and acute inflammation. The current treatment strategies for allergic rhinitis mainly include environmental control, medication, immunotherapy and health education, however, some patients are still unable to effectively control their symptoms in the long term after standardized treatment, and nasal congestion and runny nose cause great disturbance to the quality of their daily life. Therefore, it is urgent to investigate the mechanism of aescine sodium in relieving nasal mucosal edema in allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

* Adult patients (18-65 years).
* Patients with allergic rhinitis were diagnosed based on clinical history and positive sensitization tests (skin prick test and/or specific IgE).

Exclusion Criteria:

* Received glucocorticoids, immunomodulatory, antihistamine drugs, and other medications that may affect the study results within the last 1 month.
* Nasal diseases such as upper respiratory tract infections, chronic sinusitis with or without nasal polyps, and nasal sinus tumors.
* History of nasal sinus surgery.
* With other immune and allergic diseases.
* Patients with a combination of severe cardiac, cerebrovascular or pulmonary - diseases, aspirin triad, primary ciliary dyskinesia, immune deficiency, and coagulation disorders.
* Pregnant women.
* Smokers.

Primary outcomes:
measure: Rhinoconjunctivitis Quality of Life Questionnaire
timeFrame: baseline and 20 days
measure: Visual analogue scale
timeFrame: baseline and 20 days
measure: The concentration of interleukin 4(IL-4), interleukin 5(IL-5), interleukin 13(IL-13)
timeFrame: baseline and 20 days
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
Study officials:
References:
citation: Al-Digheari A, Mahboub B, Tarraf H, Yucel T, Annesi-Maesano I, Doble A, Lahlou A, Tariq L, Aziz F, El Hasnaoui A. The clinical burden of allergic rhinitis in five Middle Eastern countries: results of the SNAPSHOT program. Allergy Asthma Clin Immunol. 2018 Nov 19;14:63. doi: 10.1186/s13223-018-0298-x. eCollection 2018.
citation: Cheng L, Chen J, Fu Q, He S, Li H, Liu Z, Tan G, Tao Z, Wang D, Wen W, Xu R, Xu Y, Yang Q, Zhang C, Zhang G, Zhang R, Zhang Y, Zhou B, Zhu D, Chen L, Cui X, Deng Y, Guo Z, Huang Z, Huang Z, Li H, Li J, Li W, Li Y, Xi L, Lou H, Lu M, Ouyang Y, Shi W, Tao X, Tian H, Wang C, Wang M, Wang N, Wang X, Xie H, Yu S, Zhao R, Zheng M, Zhou H, Zhu L, Zhang L. Chinese Society of Allergy Guidelines for Diagnosis and Treatment of Allergic Rhinitis. Allergy Asthma Immunol Res. 2018 Jul;10(4):300-353. doi: 10.4168/aair.2018.10.4.300.
citation: Lee HC, Yu HP, Liao CC, Chou AH, Liu FC. Escin protects against acetaminophen-induced liver injury in mice via attenuating inflammatory response and inhibiting ERK signaling pathway. Am J Transl Res. 2019 Aug 15;11(8):5170-5182. eCollection 2019.
citation: Lindner I, Meier C, Url A, Unger H, Grassauer A, Prieschl-Grassauer E, Doerfler P. Beta-escin has potent anti-allergic efficacy and reduces allergic airway inflammation. BMC Immunol. 2010 May 21;11:24. doi: 10.1186/1471-2172-11-24.
citation: Gallelli L. Escin: a review of its anti-edematous, anti-inflammatory, and venotonic properties. Drug Des Devel Ther. 2019 Sep 27;13:3425-3437. doi: 10.2147/DDDT.S207720. eCollection 2019.