天竺葵根提取物(Pelargonium sidoides root extract) - 在研适应症：普通感冒，咳嗽_专利_临床

概要

基本信息

药物类型

中药

别名

EPs® 7630、V Clear EPs 7630

靶点-

作用机制-

治疗领域

感染呼吸系统疾病

在研适应症

普通感冒咳嗽

非在研适应症-

原研机构

Dr. Willmar Schwabe GmbH & Co. KG

在研机构

Johnson & Johnson Pacific Pty Ltd.

非在研机构

Dr. Willmar Schwabe GmbH & Co. KG

最高研发阶段批准上市

首次获批日期

澳大利亚 (2024-05-01),

普通感冒咳嗽

最高研发阶段(中国)-

特殊审评-

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关联

6

项与天竺葵根提取物相关的临床试验

NCT06353477 / Completed临床2/3期IIT

Use of EPs®7630 in Hand, Foot and Mouth Disease

This randomized controlled study aims to evaluate the effectiveness and safety of the pharmaceutical extract EPs® 7630 from P.sidoides in treating hand, foot, and mouth disease in children. The study will investigate the impact of EPs® 7630 on the severity of the disease over a specific period and its effects on hospitalization rates and potential complications. This research aims to contribute to the treatment of hand, foot, and mouth disease in children.

开始日期2019-06-01

申办/合作机构

Eskisehir Osmangazi üniversitesi

[+1]

NCT02174653 / Completed临床3期

Safety and Intake Effect of EPs® 7630 (an Extract of the Roots of Pelargonium Sidoides) A Prospective, Monocentric, Randomised, Double-blind, Placebo-controlled Clinical Trial

The aim of the study is to evaluate the safety of the intake of EPs® 7630 during a long-term (4 months) medication. The protective effects of EPs®7630 and its effects during a cold episode will also be studied.

开始日期2014-03-01

申办/合作机构

Dr. Willmar Schwabe GmbH & Co. KG

ISRCTN65790556 / Completed临床4期

EPs® 7630 film-coated tablets in subjects (greater than or equal to 18 years old) suffering from common cold: a prospective, multicentre, single-arm, open-label, phase IV clinical post-marketing safety study

开始日期2011-01-10

申办/合作机构

Dr. Willmar Schwabe GmbH & Co. KG

100 项与天竺葵根提取物相关的临床结果

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100 项与天竺葵根提取物相关的转化医学

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100 项与天竺葵根提取物相关的专利（医药）

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12

项与天竺葵根提取物相关的文献（医药）

2021-02-01·Laryngoscope Investigative Otolaryngology3区 · 医学

Effects of Pelargonium sidoides extract vs roxithromycin on chemokine levels in nasal secretions of patients with uncomplicated acute rhinosinusitis

3区 · 医学

ArticleOA

作者: Perić, Aleksandar ; Vojvodić, Danilo ; Perić, Aneta V. ; Vezmar Kovačević, Sandra ; Barać, Aleksandra

AbstractBackgroundPrevious investigations suggest the use of extract from the roots of Pelargonium sidoides (EPs 7630) for the therapy of uncomplicated rhinosinusitis. The aim of this prospective study was to compare the effects of herbal drug EPs 7630 and antibiotic roxithromycin on chemokine production in nasal mucosa and clinical parameters in patients with uncomplicated acute bacterial rhinosinusitis (ABRS).MethodsSeventy‐eight ABRS patients were divided into 26 patients receiving EPs 7630 tablets, 3 × 20 mg/day per os (group 1), 26 patients receiving roxithromycin tablets, 2 × 150 mg/day per os (group 2), both for 10 days, and 26 patients who received no therapy (Control group). We measured chemokine levels in nasal secretions by flow cytometry and assessed clinical parameters on day 0 and day 10 of investigation.ResultsEPs 7630 increased concentrations of MCP‐1 (P = .001) and IP‐10 (P = .049) and decreased levels of MIP‐1α (P < .001), ENA‐78 (P < .001), and IL‐8 (P < .001). Roxithromycin increased levels of IP‐10 (P = .049) and decreased levels of MCP‐1 (P < .001), MIP‐1α (P < .016), ENA‐78 (P < .001), and IL‐8 (P < .001). Comparison of the non‐treated patients' group with groups 1 and 2 revealed significant improvement of all clinical parameters in treated patients (P < .001), but therapy with roxithromycin resulted in better improvement in nasal symptoms and endoscopic findings than therapy with EPs 7630.ConclusionOur results suggest the presence of similar modulatory effects of both therapies on production of chemokines that regulate the function of neutrophils and monocytes in nasal mucosa. Roxithromycin shows better clinical efficacy than EPs 7630 in patients with uncomplicated ABRS.Level of Evidence1b.

2021-01-01·Vestnik otorinolaringologii

Herbal medicine for acute sinusitis — current trends

Review

作者: Nosulya, E V ; Yushkina, M A ; Kim, I A

THE AIM OF THE STUDYWas to summarize data on the role and place of herbal remedies, in particular, the extract from the roots of Pelargonium sidoides (EPs 7630) in the treatment of acute sinusitis.MATERIAL AND METHODSMaterials of scientific publications included in the Cochrane Library, information bases of the RSCI, MEDLINE, PubMed were used as a data source. The choice of material was carried out according to the keywords: epidemiology of acute sinusitis, modern treatment of acute sinusitis, colds, herbal remedies, Pelargonium sidoides.RESULTSAnalysis of published clinical trial data demonstrates evidence that EPs 7630 is significantly superior to placebo in reducing the duration and severity of symptoms of acute respiratory infection and indicates the advisability of including an extract from Pelargonium sidoides (EPs 7630) roots in OS treatment protocols. The high safety profile and clinically significant efficacy of this drug make EPs 7630 an important component of drug therapy for acute sinusitis.

2020-10-01·Annals of Otology, Rhinology & Laryngology4区 · 医学

Herbal Drug EPs 7630 versus Amoxicillin in Patients with Uncomplicated Acute Bacterial Rhinosinusitis: A Randomized, Open-Label Study

4区 · 医学

Article

作者: Gaćeša, Dejan ; Perić, Aleksandar ; Perić, Aneta V. ; Sotirović, Jelena ; Barać, Aleksandra

Objective: Previous investigations suggest the use of extract from the root of Pelargonium sidoides (EPs 7630) for the therapy of uncomplicated acute upper airway inflammations, due to its strong antimicrobial and immunomodulatory effect. We aimed to compare clinical efficacy, safety and bactericidal effect of EPs 7630 and amoxicillin monotherapy in treatment of patients with mild to moderate acute bacterial rhinosinusitis (ABRS). Methods: Fifty ABRS patients were divided into two groups by randomization. Group 1 (n = 25) received EPs 7630 tablets, 3 × 20 mg/day per os for 10 days. Group 2 (n = 25) received amoxicillin tablets 3 × 500 mg/day per os, for 10 days. We assessed total symptom score (TSS), individual symptom scores for each symptom (nasal obstruction, rhinorrhea, postnasal drip, facial pain/pressure, loss of the sense of smell), endoscopic findings, including total endoscopic score (TES) and individual endoscopic signs (mucosal edema, mucopurulent secretion), before and after treatment. Samples of discharge taken from the middle meatus of all patients were cultivated for bacteria before and after therapy. Results: Higher absolute improvement after treatment was found for TSS, nasal obstruction, facial pain/pressure, impaired sense of smell, TES, mucosal edema and mucopurulent secretion in EPs 7630 group compared to amoxicillin group ( P < .001 for all parameters). However, there were no differences in absolute improvement of rhinorrhea score and postnasal drip score between groups ( P = .248; P = .679, respectively). Fewer types of bacteria grew on culture from middle meatal samples in EPs 7630 group compared to amoxicillin group. There were no reported adverse events from patients from either group. Conclusion: Our results demonstrated better clinical and antimicrobial efficacy of EPs 7630 than amoxicillin. EPs 7630 was shown as a potent agent and good alternative to antibiotic treatment of uncomplicated ABRS.

100 项与天竺葵根提取物相关的药物交易

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研发状态

批准上市

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适应症	国家/地区	公司	日期
普通感冒	澳大利亚	Johnson & Johnson Pacific Pty Ltd.	2024-05-01
咳嗽	澳大利亚	Johnson & Johnson Pacific Pty Ltd.	2024-05-01

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适应症	最高研发状态	国家/地区	公司	日期
普通感冒	药物发现	英国	Dr. Willmar Schwabe GmbH & Co. KG	2014-03-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06353477 (Pubmed)	临床2/3期	手足口病 human enteroviruses (EVs) \| coxsackieviruses (CVs)	208	EPs® 7630	蓋簾夢獵顧壓鹽衊選選(餘夢淵鏇膚齋願夢廠餘) = No side effects were observed, except for unpleasant taste, which was reported in 5 patients (EPs® 7630 group) 獵壓憲製簾網膚繭積齋 (衊夢淵範鬱鑰窪觸蓋夢 )	积极	2024-01-01
				EPs® 7630 (Control)