A formula containing New Zealand boysenberry and a variety of plants to relieve coughs and protect the lungs.

Abstract

A composition that combines BerriQi ® Contains boysenberry, ivy leaf extract, marshmallow root extract, French coastal pine bark extract and peppermint oil, for the prevention of asthma attacks, symptom control during asthma attacks, symptom relief and recovery from acute respiratory infections.

Description

Technical area

[0001] The invention relates to the use of freeze-dried fruit powder from New Zealand boysenberry, ivy leaf extract, French coastal pine bark extract, marsh althea root extract, echinacea extract, vitamin C, and zinc for improving coughs and other respiratory symptoms of various causes, as well as for preventing asthma attacks by placing the body in an anti-inflammatory environment and maintaining normal lung function. This composition is suitable for use in children. Background technology

[0002] The human body requires oxygen to support normal cellular metabolism and vital activities. Gas exchange is a core function of the respiratory system. The human respiratory system includes the upper respiratory tract (nasal cavity, pharynx, larynx) and the lower respiratory tract (trachea, bronchi, lungs). Air enters the lungs via the nasal cavity, pharynx, larynx, trachea, and bronchial passages, and ultimately diffuses through the alveoli into the capillaries surrounding the alveoli.

[0003] According to the World Health Organization (WHO), respiratory diseases are the second leading cause of health problems after cardiovascular disease, and lower respiratory tract infections remain the world's deadliest infectious diseases and the fourth leading cause of death. According to UNICEF, pneumonia is the world's leading infectious killer of children, killing more than 725,000 children under the age of five each year. A study in the medical journal The Lancet found that children who had a lower respiratory tract infection such as bronchitis or pneumonia by the age of two were almost twice as likely as adults to die from respiratory diseases in their home country.

[0004] Respiratory infections and the development of the immune system during infancy determine lifelong lung health. Children have a higher respiratory rate, breathe more often through the mouth than adults, and nasal filtration efficiency is lower than in adults. This makes children's airways and lungs more vulnerable to the accumulation of pollutants. Children's airways are narrower than those of adults, making them more susceptible to changes in lung function. Furthermore, children's immune systems are not yet fully developed, making them more susceptible to infection by pathogens.

[0005] Pathogens that affect respiratory health include bacteria, viruses, mycoplasma, and chlamydia, with viral infections being the most common. Common bacterial species include conjugated bacteria and Streptococcus pneumoniae; common viral species include influenza viruses, the novel coronavirus, and respiratory syncytial virus (RSV). Mycoplasmas are pathogenic microbes with a size between that of a virus and that of a bacterium. Mycoplasma pneumoniae is the leading cause of lower respiratory tract infections in children.

[0006] The 2019 COVID-19 pandemic, caused by the novel coronavirus (SARS-CoV-2), is the most serious global health crisis of the 21st century. Of the 4.4 million COVID-19 deaths reported in the MPIDR-COVerAGE database, 0.4% (more than 17,400) were among children and adolescents under the age of 20. Of the 17,400 reported deaths among those under the age of 20, 53% were among 10- to 19-year-olds and 47% were among those aged 0- to 9-years-old.

[0007] A new feature of viral transmission after COVID-19 is that it is not seasonal but circulates year-round. Some people experience long-term symptoms after a COVID-19 infection. The most commonly reported long-term symptoms in children with COVID-19 include insomnia, respiratory symptoms (chest pain and tightness), nasal congestion, fatigue, muscle and joint pain, difficulty concentrating, exhaustion, difficulty breathing, and a persistent cough. These symptoms can last 60 to 120 days, and 42.6% of people with long-term symptoms continued to experience them after 120 days.

[0008] Before the age of 10, a child's immune system gradually matures. As they age, children develop resistance to common pathogens through natural infection and vaccination. However, due to increased school attendance and social activities, children are more frequently exposed to pathogens, increasing the likelihood of infection.

[0009] Recurrent respiratory tract infections (RTIs) are defined as an increase in the number of upper and lower respiratory tract infections occurring within a year above a certain range. It is generally accepted that there are at least eight respiratory tract infections per year in children under three years of age and at least six in children over three years of age. Recurrent respiratory tract infections are very common, affecting 10 to 15 percent of children. They are the leading cause of hospital admissions in developed countries, accounting for 8 to 18% of hospital admissions in the United Kingdom. The situation is less positive in developing countries. Recurrent respiratory tract infections are estimated to result in two million deaths per year.

[0010] During a respiratory infection, a number of respiratory and systemic symptoms occur: (1) Fever: Cytokines released during the inflammatory response, such as interleukins and interferons, act on the brain's temperature regulation center, raising body temperature. This increase in body temperature is often accompanied by chills, sweating, and general fatigue. (2) Throat discomfort: The accumulation of immune cells and the release of inflammatory mediators lead to vasodilation of the bronchial mucosa, increased blood flow, increased permeability of the vascular walls, and leakage of immune cells and body fluids into the tissue space. This results in hyperemia and edema of the bronchial mucosa. The specific symptoms are redness and swelling of the mucosa, pain upon swallowing, and hoarseness. (3) Cough: A viral infection irritates the sensory nerve endings of the airways, triggering the cough reflex. This results in an explosive exhalation that clears excess mucus, pathogens, and inflammatory products from the airways. The cough can be dry or moist (with phlegm) and worsens at night. Cough can also be triggered by foreign bodies, chemical, or thermal stimuli and is one of the most common cardiorespiratory symptoms, prompting medical attention. (4) Airway spasms: An infection causes inflammation of the airways, leading to an overreaction of the bronchial smooth muscles and triggering spasms. This is particularly pronounced in patients with asthma or those with airway hyperresponsiveness. It manifests as wheezing, shortness of breath, and chest tightness, especially when exhaling. (5) Excessive mucus production: An infection stimulates the goblet cells of the respiratory mucosa to produce more mucus to trap and expel pathogens and infectious debris. This may manifest as a runny nose, nasal congestion, or coughing up mucus that may be thick and discolored.

[0011] Coughing is a very important protective reflex and can occur even in healthy people. This reflex keeps the lower airways open and protects them from inhaled particles or excessive mucus production. Coughing can be an indicator of both pulmonary and non-pulmonary diseases. There are two main criteria for classifying a cough: the presence of mucus and its duration. Therefore, one can distinguish between coughs with phlegm and dry coughs, acute coughs, and chronic coughs.

[0012] Bacterial respiratory tract infections are primarily treated with antibiotics, with the appropriate antibiotic being selected based on the type of infection and bacterial species. Examples include: Penicillins (e.g., amoxicillin): Commonly used to treat strep throat and otitis media. Macrolides (e.g., erythromycin, azithromycin): For patients allergic to penicillin or for certain mycoplasma infections. Cephalosporins (e.g., cefixime, cefaclor): For the treatment of otitis media, sinusitis, etc. Additionally, antipyretic analgesics such as paracetamol or ibuprofen can be used in combination to reduce fever and pain.

[0013] Treatment options for viral respiratory infections: (1) Symptomatic treatment: Fever-reducing analgesics: Medications such as acetaminophen (Tylenol) or ibuprofen (Edvard) can be used to relieve symptoms such as fever, headache, and muscle aches. Cough suppressants: Cough suppressants or expectorants can be used to reduce cough symptoms. Decongestants and antihistamines: These are used to reduce symptoms such as nasal congestion and runny nose, but are not suitable for long-term use, especially in children. (2) Use of antiviral drugs: For influenza virus infections, antiviral medications such as oseltamivir (Tamiflu) can be used, especially in high-risk children. For other specific viruses, such as COVID-19, official guidelines should be followed to apply appropriate antiviral treatment. (3) Vaccination: Vaccines against influenza, etc. can reduce the risk of infection through prevention.

[0014] Respiratory tract infections can be divided into upper respiratory tract infections and lower respiratory tract infections depending on the site of infection.

[0015] Upper respiratory tract infections affect the nasal cavity, pharynx, larynx, and sinuses. Typical symptoms include a runny nose, sore throat, sneezing, a mild cough, and a mild fever.

[0016] Lower respiratory tract infections affect the trachea, bronchi, and lungs and are characterized by more severe symptoms and a longer recovery time. Symptoms include a severe cough with or without phlegm, shortness of breath, high fever, chest pain, and a feeling of extreme fatigue.

[0017] If upper respiratory tract infections are not treated thoroughly, the infection can spread downward and lead to lower respiratory tract infections.

[0018] Respiratory diseases can be divided into acute infections and chronic respiratory inflammations depending on their duration and pathological mechanism.

[0019] Acute infections such as colds, flu, and viral pneumonia can heal within 1-2 weeks.

[0020] Chronic airway inflammation refers to a long-term inflammatory response that typically lasts for months or longer. It is characterized by recurrent symptoms, a persistent inflammatory response, and, at times, structural changes. Chronic airway inflammation includes asthma and chronic obstructive pulmonary disease.

[0021] According to the World Health Organization (WHO), asthma is the most common chronic disease in children, with more than one-third of cases of bronchial asthma worldwide occurring before the age of 12. It is characterized by inflammation of the airways and high sensitivity to certain irritants, resulting in repeated episodes of wheezing, shortness of breath, chest tightness, and coughing. Asthma is chronic airway inflammation. Long-term asthma can lead to permanent changes in the structure of the airways, known as airway remodeling. These permanent changes, such as basement membrane thickening, smooth muscle hyperplasia, and an increase in fibrous tissue, can in turn make the airways more vulnerable to irritation, creating a vicious cycle. Furthermore, this can lead to inflammatory lung damage and reduced lung function.As a result, children are susceptible to exercise tolerance, airway constriction, and recurrent respiratory infections in adulthood.

[0022] The goal of treating childhood asthma is to control symptoms, prevent asthma attacks, and maintain normal lung function through long-term management and personalized treatment. Treatment primarily consists of reducing airway inflammation and sensitivity through the use of control medications, relieving acute symptoms with rescue medications, and reducing the likelihood of attacks by identifying and avoiding triggers.

[0023] In chronic asthma, there is evidence of tissue remodeling, fibrosis, and a resulting loss of lung function. Fibrosis and remodeling processes are also associated with chronic obstructive pulmonary disease (COPD). Remodeling is evidenced by a progressive increase in symptoms such as shortness of breath and a corresponding decrease in response to bronchodilators. Current asthma treatments aim to control inflammation and reduce the symptoms and severity of asthma attacks. Treatment for COPD also aims to control inflammation and improve airflow. However, there are no known asthma or COPD medications that can prevent airway remodeling, and no treatments are currently available to prevent abnormal remodeling processes.

[0024] Infections with respiratory syncytial virus (RSV) and rhinovirus are very common in infancy and are closely associated with the onset of asthma. The infection can cause long-lasting airway inflammation and structural changes that lead to airway hypersensitivity. Repeated viral infections can exacerbate airway sensitivity, and the long-term effects can persist even after the infection has cleared.

[0025] The fundamental object of the invention is to provide an effective treatment to improve the symptoms of cough and chronic airway inflammation caused by various causes. This is achieved by the regimen described in the claims.

[0026] Therefore, the invention provides a composition in which BerriQi ®Boysenberry is used as the main ingredient, along with ivy leaf extract, French coastal pine bark extract, althea root extract, echinacea extract, vitamin C, and zinc. This composition can improve respiratory symptoms such as cough through anti-inflammatory effects, relieve airway muscle spasms, repair mucous membranes, and remove mucus. Furthermore, it can prevent asthma attacks and maintain normal lung function.

[0027] US20200237844A1 relates to the use of compositions made with boysenberries and apples for the treatment or prevention of respiratory diseases, including but not limited to: inflammation, asthma, chronic obstructive pulmonary disease (COPD), allergic airway inflammation, reactive airway disease, airway fibrosis, and airway remodeling.

[0028] EP4164611A1 relates to the use of BerriQi® Boysenberry as anthocyanin syrup, which works synergistically with quercetin syrup to increase lung elasticity, reduce inflammation in the lungs, minimize fluid accumulation in the lungs, promote the removal of mucus from the patient's lungs, reduce lung inflammation, and thereby improve respiratory function of the lungs and / or stop or decrease viral replication.

[0029] DK2908834T3 relates to the use of compositions containing ivy extract and echinacea extract for the prevention of various respiratory diseases or for the relief and / or elimination of their symptoms. WO2019199260A2 relates to the use of compositions containing ivy extract and echinacea extract for the treatment of various respiratory diseases such as colds, coughs, allergic asthma, seasonal allergic rhinitis, bronchitis, pharyngitis, laryngitis, and pneumonia.

[0030] US6197306B1 relates to a herbal composition for the treatment of chronic obstructive pulmonary disease (COPD), bronchitis and respiratory diseases and to a process for its preparation.

[0031] Most over-the-counter cough medicines on the market contain decongestants, antihistamines, cough suppressants, and expectorants, all of which are associated with a variety of side effects. Commonly used remedies include cough suppressants (e.g., dextromethorphan), expectorants (e.g., guaifenesin), antihistamines (e.g., diphenhydramine), and decongestants (e.g., pseudoephedrine). These medications work by suppressing the cough reflex, thinning mucus, relieving allergy symptoms, or reducing nasal congestion. However, they can cause side effects such as drowsiness, dizziness, and increased heart rate, and many are not recommended for children under 2 years of age.

[0032] The formulations described in the literature targeting respiratory diseases are mostly based on symptom management in existing technologies, combining herbal ingredients with a history of traditional use, and a lack of natural ingredients targeting anti-inflammatory mechanisms. Furthermore, the existing ingredient combinations are complex, and some ingredients lack safety validation for children.

[0033] Compared to the state of the art, the invention offers a directly drinkable liquid product with BerriQi ®Boysenberry as the main ingredient, combined with ivy leaf extract, French coastal pine bark extract, althea root extract, echinacea extract, vitamin C, and zinc, helps the body transition from an inflammatory state to an anti-inflammatory environment. It is suitable for relieving respiratory and asthma symptoms caused by various causes. It can be used to treat acute and chronic respiratory diseases such as the common cold, pharyngitis, asthma, allergic rhinitis, and more.

[0034] The invention has the following advantages: It contains no chemical pharmaceutical ingredients, is made from natural plant components, eliminates various alkaloids that could cause side effects, and contains no alcohol or allergens. The delivery method allows for proper and safe absorption of the active ingredients in dissolved form.

[0035] The individual uses and functional mechanisms of each ingredient are described below: The boysenberry is a cross between blackberries and red raspberries and belongs to the genus Rubus in the rose family. It thrives in temperate climates and prefers fertile, well-drained soils. Its aggregate fruit has a deep purple color and combines the sweet and sour flavors of blackberries and raspberries. The boysenberry was first cultivated in California in the 1920s by Rudolph Boysen. It was later introduced to New Zealand, where the mild climate and abundant rainfall, particularly in parts of the South Island and the northern part of the North Island, provide ideal conditions for growing berries like the boysenberry. Relatively cool summers and mild winters create optimal conditions for boysenberry cultivation. New Zealand is a major producer and exporter of boysenberries, and its products are popular on the global market due to their high quality.The boysenberry is used not only as a fresh food but also in food processing, for example in the production of brines and desserts, and is rich in nutrients, making it a new ingredient for a healthy diet.

[0036] BerriQi ® BerriQi is a brand of Anagenix, a New Zealand company that produces freeze-dried powder from boysenberries and apples grown 100% in New Zealand. ®Contains boysenberry anthocyanins and ellagitannins, as well as apple proanthocyanidins. These substances have been shown to be involved in various molecular signaling pathways and cellular mechanisms related to the resolution of inflammation and post-inflammatory repair of airway tissue. Boysenberries are used to treat or prevent respiratory diseases such as airway inflammation, including asthma, chronic obstructive pulmonary disease (COPD), allergic airway inflammation, reactive airway disease, airway fibrosis, and airway remodeling.

[0037] Fibrosis, such as airway or pulmonary fibrosis, is the process by which normal tissue is replaced by excessive fibrous connective tissue. Increased deposition of extracellular matrix may occur in the airways of patients with fibrosis, for example, in the reticular basement membrane, lamina propria, and / or submucosa. Scarring and the accumulation of excess fibrous connective tissue can cause the airway walls to thicken. Symptoms may include reduced oxygenation, shortness of breath, chronic cough, fatigue and / or weakness, chest discomfort (including chest pain), loss of appetite, and weight loss.

[0038] Airway remodeling refers to a progressive and irreversible decline in airway function due to structural changes in the airway walls caused by chronic inflammatory processes. It typically occurs in chronic airway diseases such as asthma and chronic obstructive pulmonary disease (COPD). Remodeling can affect all layers of the airway wall and occur in any part of the airway, from the large airways to the small airways. Remodeling can lead to significant changes in epithelial tissue. Damaged epithelial cells release profibrotic cytokines, including EGF and TGF-β, which promote fibroblast proliferation, myofibroblast activation, and ultimately the formation of subepithelial fibrosis. Hypertrophy and hyperplasia of airway smooth muscle lead to thickening of the airway walls.This in turn accelerates the decline in lung function and leads to irreversible or only partially reversible narrowing of the airways.

[0039] BerriQi ® Boysenberries and apples contain antioxidants such as quercetin, which may help protect children's lungs from oxidative stress caused by pollutants, allergens, and pathogens. Antioxidants support lung health by neutralizing free radicals and reducing inflammation.

[0040] BerriQi ® Contains anthocyanins and other polyphenols with anti-inflammatory properties that can help relieve lung inflammation, reduce symptoms of respiratory infections, and promote faster recovery. Studies have shown that BerriQi ®can reduce the total number of immune cells invading the lungs after acute inflammation, particularly eosinophils, neutrophils, and T cells in the lungs. This promotes the transition of the lungs to an anti-inflammatory environment, thus reducing tissue damage caused by inflammation, swelling of the lung tissue, and the infiltration and accumulation of immune cells. Furthermore, boysenberry significantly reduces the accumulation of mucus-producing cells in the lungs and reduces mucus production. Therefore, boysenberry is associated with a reduction in lung inflammation and improved lung function in asthma and other lung diseases.

[0041] Boysenberry consumption supports the ability of fibrolytic macrophages to improve chronic lung remodeling. Pulmonary fibrosis is associated with the development of a fibrotic macrophage phenotype. In a mouse model of chronic antigen-induced airway inflammation, BerriQi activates ®Boysenberry repairs macrophages, reduces collagen deposition, improves tissue remodeling, and prevents lung scarring. Researchers found selective activation of macrophages in mice that consumed boysenberries as a source of matrix metalloproteinase-9 (MMP-9). Oral treatment with boysenberries can slow chronic tissue remodeling by supporting the development of pro-fibrotic, MMP-9-expressing macrophages. Therefore, regular consumption of boysenberries has the potential to slow chronic lung remodeling and fibrosis in asthma and other chronic lung diseases by reducing the accumulation of lung collagen and repairing damaged lung tissue.

[0042] Safety of boysenberry consumption in children: Studies have shown that immune system maturation and the response to inflammation depend on good nutritional status and can be mediated by the composition and function of the gut microbiota as well as epigenetic mechanisms. Minerals and vitamins play a crucial role in both the innate and adaptive immune response, and adequate intake and serum levels are essential to reduce susceptibility to infections. Boysenberries and apples are both rich in polyphenols and have demonstrated effective immunomodulatory properties. Bioactive compounds enhance the immune response by directly increasing the cytotoxic activity of natural killer cells, macrophages, and neutrophils. When consumed in small children as part of a balanced diet, boysenberries are very safe for children.

[0043] The French coastal pine (Pinus pinaster), also known as the European red pine, is found primarily in the Mediterranean region, particularly in large areas of the Landes Forest in southwestern France. These pines have a long history of cultivation, primarily for windbreaks and sand stabilization, timber production, and resin extraction. French coastal pine bark extract (commonly known as pycnogenol) is rich in polyphenolic compounds, particularly proanthocyanidins (OPCs), making it particularly interesting in the field of health and wellness.

[0044] French coastal pine bark extract offers a variety of health benefits and is used in dietary supplements and functional skin care products: (1) Antioxidant effect: Protects cells from damage caused by oxidative stress and thus prevents chronic diseases such as cardiovascular diseases and cancer. (2) Anti-inflammatory effect: Regulates the inflammatory response and reduces tissue damage caused by inflammation, which can relieve pain and stiffness in arthritis patients. (3) Allergy symptom relief: Pycnogenol reduces seasonal allergy symptoms such as runny nose and sneezing by inhibiting the release of histamine. (4) Promote blood circulation: Improves blood circulation, increases the elasticity and strength of blood vessels, reduces the risk of high blood pressure and relieves symptoms such as varicose veins and edema. (5) Skin health: Due to its ability to promote collagen synthesis and protect collagen from degradation, pycnogenol is also used in skin care products designed to reduce wrinkles and improve skin elasticity. (6) Blood sugar regulation: Some studies have shown that pycnogenol can improve insulin sensitivity and is potentially beneficial for people with type 2 diabetes because it helps regulate blood sugar levels.

[0045] French coastal pine bark extract is effective in shortening the duration of a cold and relieving the seven main symptoms of respiratory infections: runny nose, nasal congestion, sore throat, sneezing, fever, cough, and general malaise. All symptoms clear up more quickly. Patients supplemented with French coastal pine bark extract experienced a significant reduction in days lost from work, required fewer other preparations (e.g., over-the-counter medications) for symptom control, and had a significantly lower rate of clinically significant complications. The most common complications include colds lasting longer than four days, spread of infection to the trachea, and bronchial involvement. French coastal pine bark extract is also effective in reducing the number of complications.

[0046] Ivy (Hedera helix) is a widespread climbing vine native to Europe and Western Asia. This plant is widespread worldwide due to its adaptability and evergreen leaves. Ivy leaves are used in various traditional medicine systems, particularly in Europe, where they have a long history of medicinal use. Their main uses are for respiratory conditions such as coughs and bronchitis. In Greek and Roman times, ivy was used as an analgesic and anti-inflammatory agent. Modern phytopharmacological research supports the efficacy of ivy extract in the treatment of acute and chronic respiratory conditions, particularly as a natural expectorant and cough suppressant. Ivy leaf extract preparations are approved by the European Medicines Agency for widespread use in over-the-counter, non-antibiotic cough suppressants.

[0047] Ivy leaf extract relieves coughs by loosening and removing mucus and reducing bronchiectasis. Ivy leaf extract contains saponins, which have surface-active properties. By reducing surface tension, saponins can thin mucus and make it more fluid, helping the body clear mucus from the respiratory tract more easily. This thinning makes coughing more effective, helps soothe coughs, promotes the clearance of bronchial secretions, and facilitates the relief of chest tightness caused by colds. Once the mucus is cleared, coughing fits occur less frequently.

[0048] Ivy leaf extract also helps relieve muscle spasms in the airways, open the airways, reduce airway resistance, clear the respiratory system, allow more air into the lungs, and relieve respiratory symptoms such as chest congestion and coughing. In irritated conditions, type II alveolar cells and human airway smooth muscle cells pretreated with alpha ivy showed increased beta-adrenergic reactivity. In acute bronchitis, β2-adrenergic receptors in smooth muscle cells play an important role.

[0049] β2-adrenergic receptors are a class of receptors located on the smooth muscle cells of the bronchi and respond to stimulation by hormones such as adrenaline and noradrenaline. When activated, these receptors can produce the following effects: (1) Relaxation and dilation of bronchial muscles: Activation of β2-adrenergic receptors can lead to relaxation of bronchial smooth muscles, allowing bronchial dilation and increasing airway patency. This is especially important for patients with acute bronchitis, as it helps relieve symptoms such as shortness of breath and wheezing. (2) Increased ciliary movement: Activation of β2-adrenergic receptors can also improve the ability of cilia to remove mucus and other foreign bodies from the airways, thereby maintaining airway cleanliness.

[0050] The bronchial epithelium consists primarily of ciliated cells and is interspersed with mucus-producing cells. The normal human airway is covered with mucus, which has several protective functions, including capturing and removing foreign substances through ciliary transport and moistening the epithelial surface. Physiologically, approximately 100 ml of this fluid is produced daily, which resides in the airways without causing irritation. The mucus layer consists primarily of water, glycoproteins, glycosaminoglycans, proteins and peptides, lipids, antiproteases, antioxidants, and ions derived from the epithelium and blood vessels.

[0051] Under pathological conditions, more mucus is produced, which has a higher viscosity. Acute irritation of the airways by environmental irritants, allergens, or infectious pathogens activates inflammatory / immune mediators, some of which activate mucus-producing cells on the epithelial surface and in the submucosal glands, triggering excessive mucin secretion. Mucin overproduction is a typical feature of chronic respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD), and cystic fibrosis.

[0052] A study on the effects of ivy leaf extract on the respiratory system in children showed that coughing fits, mucus production, shortness of breath, and rales were significantly improved with the use of ivy leaf extract, and the severity of the condition was significantly reduced. Ivy leaf was more effective than acetylcysteine ​​in relieving shortness of breath during coughing. Ivy leaf was comparable to the drug acetylcysteine ​​in improving symptoms in children with acute (exacerbated) bronchitis, but participants were observed to show significant improvements in the number of coughing fits and cough-related sleep disturbances, which can effectively improve nighttime cough status.

[0053] Althaea officinalis, also known as marsh mallow or swamp mallow, is a perennial herb native to the Americas and belongs to the mallow family (Malvaceae). Preparations made from the root of Althaea officinalis are approved by the European Medicines Agency for the treatment of dry coughs caused by irritation of the mouth or throat. The use of a medicinal extract of marsh mallow root provides immediate relief by forming a protective film over inflamed mucous membranes. Because this soothing layer reduces irritation of the mucosal system, regeneration is accelerated by the defense mechanisms necessary to protect the respiratory tract from environmental damage.

[0054] The main principles of herbal cough remedies are the removal of phlegm (sputum) and cough relief. It is very important to suppress a strong and persistent cough. Cough suppression is mainly attributed to the reduction of local irritation, thanks primarily to mucus, which consists of a large number of simple sugars linked by glycosidic bonds. These polymers can be linear or branched, and their molecules can consist of the same monosaccharides (homopolysaccharides) or different monosaccharides (heteropolysaccharides). Certain polysaccharides gel under certain circumstances. As a result, they interact with the water on the surface of the respiratory tract, forming a thin protective layer.In addition to protecting local areas from irritation, the polysaccharide layer also acts as a tissue moisturizer and improves protection against physical or microbial stress impulses. For this reason, herbs traditionally used to suppress coughs often contain high amounts of polysaccharides, for example, up to 11.6% in marshmallow roots, up to 50% in lichens, and about 6% in ribwort plantain leaves.

[0055] Mint has a long history of medicinal use in the treatment of coughs and other respiratory symptoms. In traditional Chinese medicine, peppermint is used as a cooling and antiseptic, primarily for colds, coughs, sore throats, and fevers. The cooling properties of peppermint can help relieve fever and sore throat caused by colds. In ancient Greece and Rome, peppermint was used as part of aromatherapy and in herbal potions to relieve respiratory symptoms. Peppermint tea or rice wine was commonly used to treat coughs and promote respiratory health. Due to its aromatic and antibacterial properties, peppermint is used as a steam inhalation to soothe the respiratory tract and reduce cough symptoms through its aromatic volatile oils.

[0056] Peppermint contains a volatile essential oil, menthol, which has a mild narcotic effect and can temporarily paralyze the nerve endings in the throat, thus relieving coughs. Menthol also helps thin and expel mucus in the airways, which is helpful in relieving coughs due to congestion and irritation. Menthol oil is approved by the European Medicines Agency for its ability to relax muscles and relieve spasms. Peppermint also has anti-inflammatory and antibacterial properties. The anti-inflammatory properties of peppermint oil can reduce inflammation in the lining of the airways and help relieve coughs caused by infections. Peppermint's antibacterial effects help suppress potential sources of infection and support the immune system's defense mechanisms.

[0057] Peppermint Safety: Peppermint can irritate the mucous membranes of the respiratory tract, and pediatricians recommend that ingesting it directly or applying undiluted essential oils may cause irritation in children. The safe dilution for children is generally between 0.5% and 2.5%, and this range is safe for consumption.

[0058] Echinacea: Echinacea has been used as a medicinal herb in North America for hundreds of years. Echinacea was first used as medicine by Native Americans in the 18th century and quickly spread throughout the United States. In the 19th century, a physician named MEL, who learned about Native American herbal remedies from Native Americans, introduced echinacea to Europe. There, it was used as a supportive treatment for colds and upper respiratory infections, as well as wounds, ulcers, eczema, and other conditions. Echinacea was originally described as a traditional remedy of Native Americans of the Great Plains. It has been used to treat numerous ailments, more than any other herb, including fever, sore throat, wound healing, and skin health.

[0059] Echinacea has immunomodulatory properties that strengthen innate immunity. It enhances the immune system's ability to fight infections caused by pathogens by activating neutrophils, macrophages, polymorphonuclear leukocytes (PMN), and natural killer cells (NK cells). Echinacea extract has been shown to improve the systemic immune response during the common cold, with the echinacea group experiencing a significantly greater reduction in daily symptom scores than the placebo group. These effects of echinacea were associated with significant and sustained increases in the total number of circulating white blood cells, monocytes, neutrophils, and NK cells. In the later stages of the common cold, echinacea treatment suppressed a rise in cold-induced superoxide production by neutrophils.These results suggest that Echinacea may relieve cold symptoms more quickly by enhancing nonspecific immune responses and neutralizing free radicals.

[0060] Vitamin C is a powerful antioxidant that supports immune system function by neutralizing free radicals and reducing oxidative stress. It supports the normal activity of immune cells, and a vitamin C deficiency can make the immune system less effective at fighting foreign pathogens. The membranes of immune cells are sensitive to oxidative stress, and vitamin C protects these cells through antioxidant protection. In addition, vitamin C has anti-inflammatory and antiviral properties that can shorten the duration of a cold and reduce its symptoms.

[0061] Zinc plays a key role in immune regulation, supporting immune signaling, improving immune system function, regulating immune cell activity (increasing the activity of anti-inflammatory cells, inhibiting the activity of pro-inflammatory cells), and supporting the activity of immunoreactive enzymes. Furthermore, zinc can inhibit the spread of viruses, especially in respiratory infections, and protect respiratory health by regulating inflammatory factors and promoting tissue repair. Adequate zinc intake can reduce the risk of upper respiratory tract infections and shorten the duration of colds.

[0062] According to the invention, a combination of BerriQi ®Boysenberry, ivy leaf extract, marshmallow root extract, French coastal pine bark extract, Echinacea aerial part extract, vitamin C, zinc, and diluted peppermint oil help maintain normal lung function and relieve coughs. The phlegm-eliminating mechanism relies primarily on BerriQi's ability to ®Boysenberry reduces pneumonia and improves changes in lung tissue caused by chronic lung diseases; the saponins in ivy leaf extract loosen mucus and dilate the trachea to allow for free breathing; the polysaccharides in marshmallow root extract reduce irritation of the aspirating mucosa; and menthol relieves muscle spasms in the respiratory tract, thus reducing coughing. Echinacea also strengthens the innate immune system and supports recovery from colds. Vitamin C and zinc are crucial for maintaining proper immune system function.

[0063] According to the invention, a combination of BerriQi ®Boysenberry, ivy leaf extract, marshmallow root extract, French coastal pine bark extract, Echinacea aerial part extract, vitamin C, zinc and diluted peppermint oil can also be used to prevent asthma attacks, control symptoms during asthma attacks, relieve symptoms and promote recovery from acute respiratory infections.

[0064] According to the present invention, the combination of BerriQi ® Boysenberry, ivy leaf extract, marshmallow root extract, French coastal pine bark extract, Echinacea extract from aerial parts of the plant, vitamin C, zinc and diluted peppermint oil form the basis of the invention, and the dosage of the combination is known to the person skilled in the art.

[0065] As is well known in the field, the appropriate dosage depends on various factors, such as body weight, age, severity of the respiratory infection, and whether the patient is in an acute phase. The dosage regimen depends on the dose, the patient's general health, and other medications being taken. Therefore, the appropriate dosage regimen of the combined drug composition of the present invention can be determined based on the above-mentioned factors by consulting a physician.

[0066] According to the present invention, the combined dosage of BerriQi ® Boysenberry, ivy leaf extract, marshmallow root extract, French coastal pine bark extract and peppermint oil: 10-1000 mg BerriQi ®Boysenberry and apple composite powder or boysenberry fruit powder, 10-200 mg ivy leaf extract, 10-500 mg marshmallow root extract, 1-50 mg French coastal pine bark extract, 5-500 mg echinacea extract, 1-30 mg peppermint oil, 10-200 mg vitamin C, 1-3 mg elemental zinc.

[0067] In a further preferred embodiment according to the invention, a combination of BerriQi ® Boysenberry, ivy leaf extract, marshmallow root extract, French coastal pine bark extract and peppermint oil following dosages: 100-1000 mg BerriQi ® Boysenberry and apple composite powder or boysenberry fruit powder, 30-200 mg ivy leaf extract, 30-500 mg marshmallow root extract, 10-50 mg French coastal pine bark extract, 10-500 mg echinacea extract, 1-30 mg peppermint oil, 50-200 mg vitamin C, 1-3 mg elemental zinc.

[0068] According to the present invention, the raw material of BerriQi ®Boysenberry in the form of freeze-dried powder.

[0069] The product of the composition according to the invention may contain excipients that facilitate ingestion and regulate the taste, such as purified water, sweeteners (such as sugar, sugar substitutes and artificial sweeteners), acidulants, fruit juices, flavorings, antioxidants, preservatives, natural or artificial flavors and vegetable essential oils.

[0070] According to the invention, combinations of BerriQi ® Boysenberry, ivy leaf extract, marshmallow root extract, French coastal pine bark extract, and peppermint oil can be found in various products, including foods, foodstuffs, (supplementary) balanced meals, dietary supplements, pharmaceutical products, and solid, liquid, or semi-solid preparations.

[0071] In addition, according to the present invention, combinations of BerriQi ® Boysenberry, ivy leaf extract, marshmallow root extract, French coastal pine bark extract and peppermint oil in liquid, powder or granule form, as a suspension as well as in hard capsules, soft capsules, drinks, capsule cups, vials, tablets, coated tablets, sül ware etc.

[0072] The preferred embodiments are listed below: According to the present invention, the daily dose of the preferred combined preparation of BerriQi ®Boysenberry, Ivy Leaf Extract, Marshmallow Root Extract, French Coast Pine Bark Extract, and Peppermint Oil: 200 mg Boysenberry Complex Fruit Powder, 60 mg Ivy Leaf Extract, 60 mg Marshmallow Root Extract, 40 mg French Coast Pine Bark Extract, 10 mg Echinacea Aerial Part Extract, 100 mg Vitamin C, 1 mg Elemental Zinc, 1-30 mg Peppermint Oil.

[0073] According to the present invention, a combination of BerriQi ® Boysenberry, ivy leaf extract, marshmallow root extract, French coastal pine bark extract and peppermint oil provided in the form of individual liquid strips. Quotes included in the description

[0074] This list of documents submitted by the applicant is generated automatically and is provided for the reader's information only. The list is not part of the German Patent and Trademark Register. Utility model applications. The DPMA assumes no responsibility for any errors or omissions. Cited patent literature US20200237844A1

[0022] EP4164611A1

[0023] DK2908834T3

[0024] WO2019199260A2

[0024] US6197306B1

[0025] Cited non-patent literature Danilo Buonsenso, Daniel Munblit, Cristina De Rose, et al. Preliminary evidence on long COVID in children. ACTA PEDIATRICA.2021

[0007] . Urs Beat Schaad, Susanna Esposito and Cem Hasan Razi. Diagnosis and Management of Recurrent Respiratory Tract Infections in Children: A Practical Guide.Archives of Pediatric Infectious Diseases.2015

[0009] G Belcaro 1, H Shu, R Luzzi,etal.The common cold winter study: Effects of Pycnogenol®on signs, symptoms, complications and costs. Panminerva Medica.2014

[0040] Larisa AJ Barnes, Matthew Leach,Dennis Anheyer,etal. The effects of Hedera helix on viral respiratory infections in humans: A rapid review.Advances in Integrative Medicine.2020

[0042] Anne Wolf,Reinoud Gosens b,Herman Meurs,Hanns Haberlein.Pre-treatment with alpha-hederin increases beta-adrenoceptor mediated relaxation of airway smooth muscle.Phytomedicine.2011

[0043] Esther Kruttschnitt, Tankred Wegener, Catherine Zahner, Silke Henzen- Bucking.Assessment of the Efficacy and Safety of Ivy Leaf (Hedera helix) Cough Syrup Compared with Acetylcysteine in Adults and Children with Acute Bronchitis.Evid Based Complement Alternat Med.2020

[0046] Odette M. Shaw, Roger D. Hurst, Janine Cooney, etal.Boysenberry and apple juice concentrate reduced acute lung inflammation and increased M2 macrophage-associated cytokines in an acute mouse model of allergic airways disease.Food Science & Nutrition.2020

[0035] Odette M. Shaw,Roger D. Hurst,and Jacquie L.Harper.Boysenberry ingestion supports fibrolytic macrophages with the capacity to ameliorate chronic lung remodeling.American Journal of Physiology-Lung Cellular and Molecular Physiology.2016.

[0036] QUOTES CONTAINED IN THE DESCRIPTION

[0000] This list of documents submitted by the applicant was generated automatically and is included solely for the convenience of the reader. This list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions. Cited patent literature

[0000] US 20200237844A1 [0027, 0074] EP 4164611A1 [0028, 0074] DK 2908834T3 [0029, 0074] WO 2019199260A2 [0029, 0074] US 6197306B1 [0030, 0074] Zitierte Nicht-Patentliteratur

[0000] Danilo Buonsenso,Daniel Munblit,Cristina De Rose,etal. Preliminary evidence on long COVID in children. ACTA PEDIATRICA.2021 [0007

[0074] Urs Beat Schaad,Susanna Esposito and Cem Hasan Razi. Diagnosis and Management of Recurrent Respiratory Tract Infections in Children: A Practical Guide.Archives of Pediatric Infectious Diseases.2015[0009

[0074] G Belcaro 1, H Shu, R Luzzi,etal.The common cold winter study: Effects of Pycnogenol®on signs, symptoms, complications and costs. Panminerva Medica.2014[0040

[0074] Larisa AJ Barnes, Matthew Leach,Dennis Anheyer,etal. The effects of Hedera helix on viral respiratory infections in humans: A rapid review.Advances in Integrative Medicine.2020[0042

[0074] Anne Wolf,Reinoud Gosens b,Herman Meurs,Hanns Haberlein.Pre-treatment with alpha-hederin increases beta-adrenoceptor mediated relaxation of airway smooth muscle.Phytomedicine.2011[0043

[0074] Esther Kruttschnitt, Tankred Wegener, Catherine Zahner, Silke Henzen- Bucking.Assessment of the Efficacy and Safety of Ivy Leaf (Hedera helix) Cough Syrup Compared with Acetylcysteine in Adults and Children with Acute Bronchitis.Evid Based Complement Alternat Med.2020[0046

[0074] Odette M. Shaw, Roger D. Hurst, Janine Cooney,etal.Boysenberry and apple juice concentrate reduced acute lung inflammation and increased M2 macrophage-associated cytokines in an acute mouse model of allergic airways disease.Food Science & Nutrition.2020[0035

[0074] Odette M. Shaw,Roger D. Hurst,and Jacquie L.Harper.Boysenberry ingestion supports fibrolytic macrophages with the capacity to ameliorate chronic lung remodeling.American Journal of Physiology-Lung Cellular and Molecular Physiology.2016.[0036

[0074]

Claims

[1] A composition containing a combination of BerriQi ® Contains boysenberry, ivy leaf extract, marshmallow root extract, French coastal pine bark extract and peppermint oil for the prevention of asthma attacks, symptom control during asthma attacks, symptom relief and recovery from acute respiratory infections. [2] A composition according to claim 1, wherein the dosage of BerriQi ® Boysenberry dosage is 10-1000 mg, ivy leaf extract dosage is 10-200 mg, marshmallow root extract dosage is 10-500 mg, French coastal pine bark extract dosage is 1-50 mg, echinacea extract dosage is 5-500 mg, peppermint oil dosage is 1-30 mg, vitamin C dosage is 10-200 mg, and zinc dosage is 1-3 mg. [3] A composition according to claim 1, wherein the amount of BerriQi ®Boysenberry is 100-1000 mg, ivy leaf extract is 30-200 mg, marshmallow root extract is 30-500 mg, French coastal pine bark extract is 10-50 mg, echinacea extract is 10-500 mg, peppermint oil is 1-30 mg, vitamin C is 50-200 mg, and zinc is 1-3 mg. [4] A composition according to any one of the preceding claims, wherein BerriQi ® Boysenberry is freeze-dried, and the raw material can be combined with other herbal ingredients.