Criteria for exclusion of the documentation were as follows: known hypersensitivity to the active ingredients, treatment with the medications in the last two weeks before study entry, participation in another trial in the same time, and legal incapacity. Subgroup evaluation was performed within the EA 575® group regarding indication at inclusion into the study and concomitant disease or infection. All of the studies involved measurements of objective and subjective parameters of efficacy (spirometric and auscultation parameters such as vital capacity, forced vital capacity, and forced expiratory volume per 1 second). Cough lasting less than 3 weeks is termed acute compared with the chronic bronchitis [11]. English ivy leaf extract might cause mild stomach problems.. Not enough is known about the safety of applying English ivy to the skin. In the United States, acute bronchitis is the ninth most common illness among outpatients, as reported by physicians [9]. The average of findings for coughing fits, sputum, dyspnoea, and rales assessed by the physicians is shown in Figure 1. The study results indicate that ivy leaf extract might be an effective alternative to acetylcysteine with respect to the improvement of respiratory function in children and adults at a slightly better evaluation of efficacy. The study was conducted at 25 medical practices throughout Switzerland as prospective, open, noninterventional study. Viral infection-caused acute bronchitis was the most common disease at entry visit with 53.4% in the EA 575® group and 57.1% in the ACC group, followed by other acute inflammation of the respiratory diseases with 25.4% in the EA 575® group and 33.3% in the ACC group. Furthermore, concomitant diseases were treated with different antibiotics or other treatment which also might have an impact on the treatment outcome for the acute bronchitis. Prospan syrup Ivy leaf dry extract Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Other characteristic symptoms include sputum production, shortness of breath, and wheezing related to the obstruction of the inflamed airways. I was prescribed ivy leaf extract for my (quite heavy) cough. With regard to duration of symptoms, no significant differences were observed between the treatment groups. IVY leaf. Significant improvement in each of the symptoms from entry visit to final visit (, Assessment of the Efficacy and Safety of Ivy Leaf (, Max Zeller Söhne AG, Seeblickstrasse 4, Romanshorn 8590, Switzerland, CONSULTING HMP, Brückstrasse 11, Weinheim 69469, Germany, Landarztpraxis Sevelen, Velturrietstrasse 5, Sevelen 9475, Switzerland, Evidence-Based Complementary and Alternative Medicine, Acute bronchitis, caused by bacterial infection (ICD-10: J20.0-J20.2) [, Acute bronchitis, caused by viral infection (ICD-10: J20.3-J20.7), Other acute inflammation of the respiratory tract accompanied with cough, The average duration of symptoms at entry visit (days), Concomitant infections and other diseases, None (N; % of patient within treatment group), R. P. Wenzel and A. The main components of ivy leaf that give it its health benefits are called saponins. Of the 118 patients included in the evaluation with EA 575®, treatment was carried out over an average period of 7.48 days. Two galenical formulations of an ivy herbal extract, syrup and cough drops, were tested for their efficacy and safety in the paediatric treatment of cough and bronchitis in two independent open, non-interventional studies with identical design. Ivy is solid at its base, and then it starts to crawl. Sign up here as a reviewer to help fast-track new submissions. ENGELHARD Arzneimittel GmbH & Co. KG Herzbergstraße 3, 61138 Niederdorfelden, Germany Module 1 Common Technical Document Prospan Syrup THR 35693/0001 Product: Cofif Plus Syrup. Two galenical formulations of an ivy herbal extract, syrup and cough drops, were tested for their efficacy and safety in the paediatric treatment of cough and bronchitis in two independent open, non‐interventional studies with identical design. * Ivy leaf supports healthy mucosa beginning with the nose, mouth, and throat, and continuing to the bronchial passageways and lungs. There was a significant improvement in the reduction of both groups from baseline to end visit. The present noninterventional study was intended to gain further data on the application of a cough syrup containing ivy leaf extract EA 575® by evaluating its efficacy and safety in children and adults with symptoms of acute bronchitis. Product: Cofif Syrup. This leads to relaxation in the bronchial muscles and plausibly explains the bronchospasmolytic effect of ivy [24]. The study revealed a significant and clinically relevant improvement in patients with acute bronchitis receiving oral treatment with EA 575®. Cough and fever are the most common symptoms of acute bronchitis in children. Ivy leaf is a source of saponins, sterols, flavonoids. It is an efficient and natural remedy for adult and children. Comparable improvement was seen for all symptoms between both groups from the entry to final visit which was statistically significant. Average values of physician’s evaluation comparing the final visit with the entry visit. containing ivy leaf extract. Effect or tolerability data was compared by repeated general linear model analysis using data from entry and final visits as intrasubject variables, treatment as between subject factor, and sex and child/adults as covariates. Hecker M. Efficacy and tolerance of Ivy extract (Prospan®) in patients suffering from respiratory tract diseases. Ivy Syrup IVY LEAF EXTRACT 50 mg Read all of this leaflet carefully because it contains important information for you. More Buying Choices. Further, the patients were asked to keep a diary during the course of treatment, which includes following symptoms: number of coughing fits during daytime, coughing intensity, chest pain during coughing, dyspnoea during coughing, possibility to cough-up mucus, cough-related sleep disturbances, frequency of wake ups at night, and general well-being. In addition, the EA 575® preparation showed to be effective in children and adults independent of the indication or concomitant disease and can therefore be used as an alternative to the synthetic ACC preparation. One patient reported at the final visit to have “discontinued treatment” after 8 days and switched to ACC due to lack of efficacy. It is important to note that the decision to treat the patient with either EA 575® or an ACC mono preparation was made before it was decided to include the patient into the noninterventional study. Acute bronchitis affects approximately 5% of adults annually, with a higher incidence observed during winter and fall than in summer and spring [3, 4]. However, there are other pharmacologic treatments for impaired mucous secretion clearance including agents such as isotonic saline and acetylcysteine (also known as N-acetylcysteine (NAC)). Early research shows that taking a cough syrup containing English ivy leaf might improve coughing and breathing in children and adults with different types of bronchitis. Essentially, all captured data are calculated as frequency distributions and descriptive analysis (e.g., averages, medians, standard deviations, minimums, and maximums). Regarding concomitant diseases, 44.1% of the subjects in the EA 575® group suffered from concomitant diseases and 38.1% in the ACC group. However, you still need to take ACTIVOX Ivy syrup carefully to get the best results from it. Liver disorders. For dyspnoea during coughing, better improvement was seen in the EA 575® group. Formulations similar to Coferb have been recognized by international clinical trials endorsing safety and efficacy of the product. It is characterized by a persistent cough which can be productive or dry. Symptoms could last up to 3 days and not longer to assure the acute situation. Ivy leaf Extract Syrup. At the beginning, BSS average was 6.5 points in the EA 575® group and 6.7 points in the group of ACC patients, respectively, showing a moderate impairment for both. There's a problem loading this menu right now. Within the 139 included patients, only 21 patients were prescribed an acetylcysteine preparation resulting in an unequal group distribution. The authors declare that there are no conflicts of interest. English ivy exhibits antiviral, antimycotic, and anthelmintic and effects and some studies indicate that the One patient reported diarrhea after she had used EA 575® for two days, and after discontinuing of the medication, the patient had recovered. Nat Med 1999;14:28–33. 13 children belonged to the class group 6–11 years with an average height of 136.0 cm and an average weight of 32.3 kg. Diseases with the leading symptom “cough” are economically relevant as respiratory diseases are the most common reason for working incapacity and affect the quality of patient’s life [2]. The clinical effects of Hedera helix have been investigated in a total of more than 20 [12–14] clinical studies mostly in children suffering from upper airway infections. A. Fowler, “Acute bronchitis,”, V. Benson and M. A. Marano, “Current estimates from the national health interview survey, 1995,”, J. Macfarlane, “Prospective study of the incidence, aetiology and outcome of adult lower respiratory tract illness in the community,”, T. C. Medici, M. Häcki, and M. V. Spiegel, “Spiegel MV. It is the most common disease in industrialized countries, and thus herbal expectorants enjoy a high popularity in many European countries due to their favorable risk-benefit ratio. The average duration for symptoms at entry visit was 2.341 days in the EA 575® group and 2.33 days in the ACC group. In the current study design (noninterventional study), the physicians were totally free in their prescription decision. In some studies, patients were requested to fill out diaries with daily assessments of, e.g., cough frequency, expectoration, and breathlessness. 4.1 out of 5 stars 65. Both, physicians and patients described the efficacy of EA 575® comparable with acetylcysteine. During the final visit, after approximately 1 week, information on the therapy and the course of the symptoms was documented. Our cough syrup works as a bronchodilator and an expectorant which eases chest congestion, inflammation of the trachea and soothes sore throat. Average weight was 66.1 kg in the EA 575® group and 71.7 kg in the ACC group. Compared with the conventional quality control method that measures the contents of hederacoside C in ivy leaf extracts, the newly developed method can provide more information about the chemical composition of ivy leaf extracts. The evaluation of the individual data on symptoms was only carried out for those patients in whom the symptom was present at the beginning of the study. Before recruitment, the study procedure was explained to the subjects in detail, after which they signed consent forms. Hedera helix preparations (ivy leaf extracts) are worldwide marketed for the treatment of different diseases of the respiratory tract system and include catarrh of the respiratory passages; symptomatic treatment of chronic inflammatory bronchial illnesses; and acute inflammations of the respiratory tract accompanied by coughing (HMPC Assessment) [1]. Review articles are excluded from this waiver policy. The results show that there is no evidence that the efficacy differs between both groups. The validated method was successfully applied to quantify all six compounds in a 30% ethanol ivy leaf extract and 13 ivy leaf extract products. Ivy leaf extract is a traditional ingredient that has been used for centuries to support bronchial health. Physicians judged the tolerability as “very good” and “good” with 99.1% for the EA 575® group and 95.2% for the ACC group. At entry visit, duration of symptoms was assessed as well (Table 3). Ivy has green, shiny and leathery leaves. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist told you. Husten und Auswurf: ursachen und Differentialdiagnosen,”, J. E. DeLozier and R. O. Gagnon, “National ambulatory medical care survey: 1989 summary,”, K. F. Chung and I. D. Pavord, “Prevalence, pathogenesis, and causes of chronic cough,”, C. C. S. Lang and T. Wegener, “Efeu in der pädiatrischen Praxis,”, A. Schaefer, F. Ludwig, B. M. Giannetti, M. Bulitta, and A. Wacker, “Efficacy of two dosing schemes of a liquid containing ivy leaves dry extract EA 575 versus placebo in the treatment of acute bronchitis in adults,”, A. Schaefer, M. S. Kehr, B. M. Giannetti, M. Bulitta, and C. Staiger, “A randomized, controlled, double-blind, multi-center trial to evaluate the efficacy and safety of a liquid containing ivy leaves dry extract (EA 575((R))) vs. placebo in the treatment of adults with acute cough,”, P. Kardos, Q. Dinh, K.-H. Fuchs et al., “Leitlinie der deutschen gesellschaft für pneumologie und beatmungsmedizin zur diagnostik und therapie von erwachsenen patienten mit husten,”, P. Kardos, S. Lehrl, W. Kamin, and H. Matthys, “Assessment of the effect of pharmacotherapy in common cold/acute bronchitis - the bronchitis severity scale (BSS),”, B. Kemmerich, R. Eberhardt, and H. Stammer, “Efficacy and tolerability of a fluid extract combination of thyme herb and ivy leaves and matched placebo in adults suffering from acute bronchitis with productive cough,”, F. J. Martinez, “Acute bronchitis: state of the art diagnosis and therapy,”, A. Gillissen, C. Gessner, S. Hammerschmidt, G. Hoheisel, and H. Wirtz, “Acute bronchitis: when are antibiotics, and when is symptomatic treatment indicated?”, G. Höffken, J. Lorenz, W. Kern et al., “S3-guideline on ambulant acquired pneumonia and deep airway infections,”, N. A. Sathe, S. Krishnaswami, J. Andrews, C. Ficzere, and M. L. McPheeters, “Pharmacologic agents that promote airway clearance in hospitalized subjects: a systematic review,”, Y. Bolbot, E. Prokhorov, S. Mokia, and A. Yurtseva, “Comparing the efficacy and safety of high-concentrate (5-7.5:1) ivy leaves extract and acetylcysteine for treatment of children with acute bronchitis,”, A. Sieben, L. Prenner, T. Sorkalla et al., “Alpha-hederin, but not hederacoside C and hederagenin from Hedera helix, affects the binding behavior, dynamics, and regulation of beta 2-adrenergic receptors,”. The physician selected the patients for whom the diagnosis enabled them to be included into the study and to be treated with the abovementioned prescriptions. The following clinical findings were documented during both visits by the physicians in accordance with the Bronchitis Severity Score (BSS) [16] by a 5-stage assessment: coughing fits, sputum, rales/rhonchi, and dyspnoea during coughing. These effects are attributable, in particular, to the therapeutically important constituents of the ivy leaf extract, which belong to the class of triterpene saponins such as hederacoside C (Figure 1), a marker and an active ingredient of ivy leaf extract [7–10]. In addition, approximately 50% of patients with acute bronchitis report the production of purulent sputum [2]. ), Clear, Herbion Naturals Ivy Leaf Syrup with Thyme and Licorice, 5 - Helps Maintain Respiratory and Bronchial Health, Supports Healthy Mucous Membranes, Effective for Adults and Children 5 Fl Oz (Pack of 1), Prospan 100mL By Helixia - Ivy Leaf Extract - Relieves Cough, Loosens Mucus & Phlegm, Zarbee's Naturals Baby Cough Syrup + Mucus with Agave & Ivy Leaf, Natural Cherry Flavor, 2 Ounce Bottle, Zarbee's Naturals Children's Cough Syrup* + Mucus Daytime & Nighttime, Grape Flavor, 4 Ounces (Pack of 2), Nature's Way B&T Nighttime Cough & Bronchial Syrup for Restful Sleep Homeopathic, Purple, Cherry 8 Fl Oz, Zarbee's Naturals Children's Cough Syrup* + Mucus with Dark Honey & Ivy Leaf, Cherry Flavor, 4 Ounce Bottle, Helixia Prospan Children's Cough Syrup ages 1 to 11, Children's Robitussin Naturals & Ivy Leaf Cough Relief Gummies, Dietary Supplement, Ages 3+, Honey, 30 Count, Robitussin Naturals Cough Relief Ivy Leaf Gummies 30ct, Robitussin Honey Adult Cough + Chest Congestion DM Maximum Strength Liquid & Robitussin Honey Adult Nighttime Cough DM Maximum Strength Liquid Value Pack (2-4 fl. These components are supportive of healthy mucous membranes and defend against occasional irritation of the lung and bronchial passages. oz. At entry visit, all clinical assessments including coughing fits, sputum, dyspnoea, rales, severity of the diseases, and coughing quality were rated with moderate intensity in both groups. Description: Cofif syrup contains IVY Leaf extract. Non-drowsy, sugar-free, alcohol-free, no added coloring with pleasant natural blackcurrant flavor. L. Ivy leaf preparations are obtained as dry, liquid and soft extracts by putting the plant material in a solvent (such as ethanol) to dissolve compounds and form a liquid extract. Since data were incomplete for this patient, it was not considered in the overall study assessment. The study was conducted as prospective, open, noninterventional cohort study by ambulant physicians (such as general practitioners, internists, paediatricians, pneumologists, and otorhinolaryngologists) throughout Switzerland. Results of trials with different extracts are only valid for the tested preparation but not for the tested plant [15]. More info about ivy leaf extract. Patients themselves rated the following symptoms that were queried by the physician: 5-staged-score for coughing intensity, chest pain during coughing, dyspnoea during coughing, cough-related sleep disturbances, and possibility to cough-up mucus and 4-staged-score for number of coughing fits during daytime. The data used to support the findings of this study are available from the corresponding author upon request. Data from a large clinical trial revealed that the median duration of cough from acute bronchitis due to all causes was 18 days [2]. And 10 children were between 14 and 17 years old with an average height of 166.1 cm and an average weight of 63.0 kg. Material and Methods. Soothing syrup provides relief from occasional irritation; Breathe Easy with Bronchial Soothe! 24.6% of the subjects from the EA 575® group suffered from acute bronchitis caused by bacterial infection and 19.0% in the ACC group (Table 2). PROSPANEX® Cough Syrup: 5 ml contains 35 mg Hedera helix leaves dry extract (DER 5–7.5 : 1) as active ingredient, manufactured by Engelhard Arzneimittel GmbH and Co. KG. NAC is used as a treatment option in various conditions in which there are problems with clearance of lung mucosal secretions. EA 575® is effectively independent of the indication or concomitant disease. We will be providing unlimited waivers of publication charges for accepted research articles as well as case reports and case series related to COVID-19. An interim analysis, which was performed 15 months after study start, showed that data of the collected 139 patients were sufficient for an explorative analysis with the group comparison. 2016-01555). 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