Delving into the Latest Updates on Pelargonium sidoides root extract with Synapse

Overview

Basic Info

Drug Type

Herbal medicine

Synonyms

EPs® 7630, V Clear EPs 7630

Target-

Mechanism-

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

Common ColdCough

Inactive Indication-

Originator Organization

Dr. Willmar Schwabe GmbH & Co. KG

Active Organization

Johnson & Johnson Pacific Pty Ltd.

Inactive Organization

Dr. Willmar Schwabe GmbH & Co. KG

Drug Highest PhaseApproved

First Approval Date

AU (01 May 2024),

Common ColdCough

Regulation-

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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.

Start Date01 Jun 2019

Sponsor / Collaborator

Eskisehir Osmangazi üniversitesi

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NCT02174653 / CompletedPhase 3

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.

Start Date01 Mar 2014

Sponsor / Collaborator

Dr. Willmar Schwabe GmbH & Co. KG

ISRCTN65790556 / CompletedPhase 4

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

Start Date10 Jan 2011

Sponsor / Collaborator

Dr. Willmar Schwabe GmbH & Co. KG

100 Clinical Results associated with Pelargonium sidoides root extract

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100 Translational Medicine associated with Pelargonium sidoides root extract

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100 Patents (Medical) associated with Pelargonium sidoides root extract

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12

Literatures (Medical) associated with Pelargonium sidoides root extract

01 Feb 2021·Laryngoscope Investigative OtolaryngologyQ3 · MEDICINE

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

Q3 · MEDICINE

ArticleOA

Author: 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.

01 Jan 2021·Vestnik otorinolaringologii

Herbal medicine for acute sinusitis — current trends

Review

Author: 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.

01 Oct 2020·Annals of Otology, Rhinology & LaryngologyQ4 · MEDICINE

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

Q4 · MEDICINE

Article

Author: 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 Deals associated with Pelargonium sidoides root extract

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Common Cold	AU	Johnson & Johnson Pacific Pty Ltd.	01 May 2024
Cough	AU	Johnson & Johnson Pacific Pty Ltd.	01 May 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Common Cold	Discovery	GB	Dr. Willmar Schwabe GmbH & Co. KG	01 Mar 2014

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06353477 (Pubmed)	Phase 2/3	Hand, Foot and Mouth Disease human enteroviruses (EVs) \| coxsackieviruses (CVs)	208	EPs® 7630	guinmecyon(qrqgblzeds) = No side effects were observed, except for unpleasant taste, which was reported in 5 patients (EPs® 7630 group) jbllrhstpy (wdutxnxqyn )	Positive	01 Jan 2024
				EPs® 7630 (Control)