[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Materia Medica Holding\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":122},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,70,97],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100641959","phase-3-clinical-trial-of-the-efficacy-and-safety-of-raphamin-in-the-treatment-of-acute-bronchitis-in-adult-patients-100641959",false,"NCT07650227","Clinical Trial of the Efficacy and Safety of Raphamin in the Treatment of Acute Bronchitis in Adult Patients","Multicenter, Double Blind, Placebo-controlled, Randomized, Parallel-group Clinical Trial of the Efficacy and Safety of Raphamin in the Treatment of Acute Bronchitis in Adult Patients","Inclusion Criteria:\n\n1. Male and female patients aged 18 to 64 years, inclusive.\n2. Confirmed diagnosis of acute bronchitis (AB) based on the presence of productive cough and one or more symptoms (wheezing in the lungs, chest \"discomfort\", shortness of breath, fever).\n3. The BSS score of at least 5 and no more than 15 points.\n4. Duration of AB symptoms does no more than 72 hours.\n5. Seasonal incidence of acute respiratory viral infections.\n6. Availability of a patient information sheet and an informed consent form for participation in the clinical trial signed by the patient.\n7. Patients who have agreed to use a reliable method of contraception during the study (for men and women of reproductive potential).\n\nExclusion Criteria:\n\n1. History of chronic obstructive pulmonary disease, chronic bronchitis, asthma, bronchiectasis, or pulmonary emphysema.\n2. Suspected pneumonia or bacterial infection (including otitis media, sinusitis, urinary tract infection, meningitis, sepsis, etc.) requiring antibiotics, starting on the first day of illness.\n3. Suspected infiltrative pulmonary tuberculosis, pulmonary embolism, pulmonary infarction, drug-induced (toxic) pneumopathy, foreign body aspiration, sarcoidosis, pulmonary alveolar proteinosis, lipoid pneumonia, or atelectasis.\n4. History of immunopathological diseases: systemic vasculitis, lupus pneumonitis, allergic bronchopulmonary aspergillosis, obliterating bronchiolitis, idiopathic pulmonary fibrosis, eosinophilic pneumonia, bronchocentric granulomatosis.\n5. Chronic heart failure with functional classes III and IV (according to the classification of the New York Heart Association, 1964).\n6. Metabolic disorders (obesity grades 2-3).\n7. History of chronic kidney disease (classes C3-5 A3); liver failure (class C according to Child-Pugh); neurological conditions (neuromuscular, neurocognitive disorders, epilepsy); hemoglobinopathy.\n8. Primary and\u002For secondary immunodeficiency (HIV infection, administration of immunosuppressive drugs, etc.).\n9. Surgery of any localization within the last 3 months.\n10. Clinical symptoms of severe influenza\u002FARI requiring hospitalization .\n11. Acute respiratory failure.\n12. History\u002Fsuspected oncological disease of any location (except for benign neoplasms).\n13. Exacerbation or decompensation of chronic diseases that affect the patient's ability to participate in the clinical trial, including diabetes mellitus.\n14. Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.\n15. Pregnancy, breastfeeding, and childbirth less than 3 months prior to study inclusion.\n16. Hypersensitivity to any component of the medications used in the treatment.\n17. Patients who have taken medications listed in the \"Prohibited Concomitant Medication\" section in the previous 1 month prior to study inclusion or who require medications prohibited for use in this study.\n18. Patients who, in the investigator's opinion, will not comply with study monitoring requirements or with the study drugs administration schedule.\n19. History of mental illness, alcoholism, or drug abuse that, in the investigator's opinion, will interfere with successful compliance with study procedures.\n20. Participation in other clinical trials within 3 months prior to study inclusion.\n21. The patient is a member of the center's research staff directly involved in the study and is an immediate family member of the investigator. Immediate family members are defined as spouses, parents, children, or siblings, regardless of whether they are biological or adopted.\n22. The patient is employed by NPF MATERIA MEDICA HOLDING LLC, i.e., is an employee of the company, a temporary contract worker, or a designated official responsible for the study, or is an immediate family member of one of these individuals..","ALL","18 Years","64 Years",{"count":20,"type":21},308,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The goal of this clinical trial is to learn if Raphamin works to treat acute bronchitis in adults. It will also learn about the efficacy and the safety of Raphamin. The main questions it aims to answer are:\n\nWill treatment with Rafamine contribute to a faster resolution of acute bronchitis symptoms, reduce the severity of the disease, and prevent the development of complications requiring antibacterial therapy compared to placebo therapy? Investigators will compare Raphamin to a placebo (a look-alike substance that contains no drug) to see if Raphamin works to treat acute bronchitis.\n\nParticipants will:\n\nTake Raphamin or a placebo for 5 days. On the first day of treatment 8 tablets of Raphamin or a placebo should be taken using the following regimen: 1 tablet every 30 minutes for the first 2 hours (5 tablets in total for 2 hours), then 1 more tablet 3 times at equal intervals during the same day. On day 2 and onwards, 1 tablet should be taken 3 times a day.\n\nFace-to-face visits are planned in the trial: Visit 1 (Day 1), Visit 2 (Day 4±1), Visit 3 (Day 7±1), and a phone Visit 4 (day 14±1). The study uses an electronic patient diary (EPD) in which symptoms of acute bronchitis (cough, sputum, chest pain during coughing) are assessed daily.",[27,28],"Bronchitis","Acute Bronchitis",[27,30,31],"Acute","Adults","RECRUITING","2026-06-24",{"date":35,"type":36},"2026-06-29","ACTUAL",{"date":38,"type":36},"2025-12-09",{"date":40,"type":21},"2028-12-31",{"name":42,"class":43},"Materia Medica Holding","INDUSTRY",33,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100585356","phase-3-the-efficacy-and-safety-of-raphamin-in-the-treatment-of-acute-rhinosinusitis-in-adult-patients-100585356","NCT06901297","The Efficacy and Safety of Raphamin in the Treatment of Acute Rhinosinusitis in Adult Patients","Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Clinical Trial of the Efficacy and Safety of Raphamin in the Treatment of Acute Rhinosinusitis in Adult Patients","Inclusion Criteria:\n\n1. Male and female aged 18 - 75 years.\n2. Diagnosis of acute rhinosinusitis:\n\n   * 8-12 points on MSS scale;\n   * no more than 3 severe symptoms (3 points on the MSS scale)\n   * facial pain\u002Fheaviness in the facial area 1-2 points on the MSS scale.\n3. Disease duration up to 48 hours (from the onset of the first symptoms of the disease).\n4. Availability of a patient information sheet and an informed consent form for participation in the clinical trial signed by the patient.\n5. Patients who agreed to use a reliable method of contraception during the study (for men and women of reproductive potential).\n\nExclusion Criteria:\n\n1. Symptoms of acute bacterial rhinosinusitis (three or more of those below):\n\n   * fever of ≥ 38.0°C;\n   * the second wave of ARS symptoms;\n   * one-sided process;\n   * facial pain\u002Fpressure of 3 points (on the MSS scale).\n2. Recurrent ARS (≥4 episodes of ARS per year with complete resolution of symptoms between episodes).\n3. Odontogenic rhinosinusitis.\n4. Allergic (seasonal or year-round) rhinitis.\n5. Nasal polyps or clinically significant nasal septum deviation.\n6. Concomitant otitis.\n7. Use of intranasal or systemic corticosteroids for 30 days prior to the screening visit.\n8. Use of intranasal or systemic antibiotics for 30 days prior to the screening visit.\n9. Surgery for the nasal cavity and paranasal sinuses during the last 6 months before the screening visit.\n10. Any other surgery during the last 3 months.\n11. Clinical symptoms of severe influenza\u002FARVI requiring hospitalization.\n12. Suspected bacterial infection of any localization requiring the administration of antibiotics from the first day of disease.\n13. History\u002Fsuspicion of oncology of any localization (except for benign neoplasms).\n14. Exacerbation or decompensation of chronic diseases (diabetes mellitus, bronchial asthma, chronic bronchitis, chronic obstructive pulmonary disease, cystic fibrosis, primary ciliary dyskinesia, bronchopulmonary dysplasia, malformations of the respiratory and ENT organs, etc.) affecting the patient's ability to participate in the clinical trial.\n15. Previously diagnosed immunodeficiency of any etiology.\n16. Unstable angina or myocardial infarction during the last 6 months.\n17. Class III and IV chronic heart failure (according to the classification of the New York Heart Association, 1964).\n18. History of chronic kidney disease (classes C3-5 A3).\n19. History of liver failure (class C according to Child-Pugh).\n20. Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.\n21. Pregnancy, breast-feeding, and childbirth less than 3 months before inclusion in the trial.\n22. Hypersensitivity to any component of the medicines used in the treatment.\n23. Patients who used medications listed under \"Prohibited Concomitant Treatment\" within 1 month prior to inclusion in the trial or need medications prohibited for use in the trial.\n24. Patients who, from the investigator's point of view, will not comply with the observation requirements during the trial or follow the procedure for taking the test drugs.\n25. History of mental illness, alcoholism, drug abuse, which, from the investigator's point of view, will prevent the patient from following the trial procedures.\n26. Participation in other clinical trials within 3 months prior to inclusion in this trial.\n27. Patient is related to on-site research personnel directly involved in the trial, or is the immediate family member of the investigator. 'Immediate family members' mean spouses, parents, children, or siblings, whether related or adopted.\n28. Patient is employed by OOO \"NPF \"MATERIA MEDICA HOLDING\", i.e., is an employee of the company, a temporary contract employee, or a designated official responsible for conducting the trial or their immediate family member.","75 Years",{"count":54,"type":21},552,[24],"Multicenter double-blind placebo-controlled randomized in parallel groups clinical trial of the efficacy and safety of Raphamin in the treatment of acute rhinosinusitis in adult patients.",[58,59],"Rhinosinusitis","Rhinosinusitis Acute",[58,30],"2026-03-12",{"date":63,"type":36},"2026-03-16",{"date":65,"type":36},"2025-04-03",{"date":67,"type":21},"2027-12-31",{"name":42,"class":43},44,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":95,"locationsCount":96},"100571103","phase-3-clinical-trial-of-the-efficacy-and-safety-of-raphamin-in-the-treatment-of-arvi-in-children-aged-3-12-years-100571103","NCT06715891","Clinical Trial of the Efficacy and Safety of Raphamin in the Treatment of ARVI in Children Aged 3-12 Years","A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Clinical Trial of the Efficacy and Safety of Raphamin in the Treatment of Acute Respiratory Viral Infection in Children Aged 3-12 Years","Inclusion Criteria:\n\n1. Children of either gender aged 3 to12 years .\n2. Diagnosis of ARVI based on the medical examination: axillary temperature ≥37.8°C at the time of examination + total severity of general symptom score ≥4 points, nasal\u002Fthroat\u002Fchest symptoms ≥2 points (ARVI Symptom Severity Score).\n3. 24 hours from the ARVI onset .\n4. Availability of a patient information sheet and an informed consent form for the patient's parents\u002Fadopters for patient participation in the clinical trial signed by one parent\u002Fadopter of the patient.\n\nExclusion Criteria:\n\n1. Clinical symptoms of severe influenza\u002FARVI requiring hospitalization.\n2. Suspected pneumonia, bacterial infection (including otitis media, sinusitis, urinary tract infection, meningitis, sepsis, etc.) requiring the administration of antibiotics from the first day of disease.\n3. Suspected early manifestations of diseases that have onset symptoms similar to those of ARVI (other infectious diseases, influenza-like syndrome at the onset of systemic connective tissue diseases and other pathologies).\n4. Patients who require administration of antiviral medications that are prohibited for use in this trial.\n5. History or prior diagnosis of primary and secondary immunodeficiency.\n6. History\u002Fsuspicion of oncology of any localization (except for benign neoplasms).\n7. Exacerbation or decompensation of chronic diseases (diabetes mellitus, cerebral palsy, cystic fibrosis, primary ciliary dyskinesia, bronchopulmonary dysplasia, malformations of the respiratory and ENT organs, etc.) affecting the patient's ability to participate in the clinical trial.\n8. Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.\n9. Allergy\u002Fhypersensitivity to any component of the medicines used in the treatment.\n10. Use of medications listed under \"Prohibited Concomitant Treatment\" within 2 weeks prior to inclusion in the trial.\n11. Patients whose parents\u002Fadopters, from the investigator's point of view, will not comply with the observation requirements during the trial or follow the procedure for taking the test drugs.\n12. History of mental illness of the patient (except for attention deficit hyperactivity disorder), parents\u002Fadopters of the patient.\n13. Participation in other clinical trials within 3 months prior to inclusion in this trial.\n14. A patient's parent\u002Fadopter is related to any of the on-site research personnel directly involved in the trial, or is the immediate family member of the investigator. 'Immediate family members' mean spouses, parents, children, or siblings, whether related or adopted.\n15. The patient's parent\u002Fadopter is employed by OOO \"NPF \"MATERIA MEDICA HOLDING\", i.e., is an employee of the company, a temporary contract employee, or a designated official responsible for conducting the trial or their immediate family member.","3 Years","12 Years",{"count":80,"type":21},374,[24],"Multicenter double-blind placebo-controlled randomized in parallel groups clinical trial.",[84],"Acute Respiratory Viral Infection",[86,87,88],"respiratory viral infection","children","aged 3-12 years","2026-03-11",{"date":91,"type":36},"2026-03-13",{"date":93,"type":36},"2024-11-11",{"date":67,"type":21},{"name":42,"class":43},35,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":104,"maxAge":77,"enrollmentInfo":105,"targetDuration":4,"studyType":22,"phases":107,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":120,"locationsCount":121},"100606096","phase-3-efficacy-and-safety-of-rengalin-in-the-treatment-of-arvi-cough-in-children-100606096","NCT07171099","Efficacy and Safety of Rengalin in the Treatment of ARVI Cough in Children","Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Clinical Trial of the Efficacy and Safety of Rengalin in the Treatment of Cough in Acute Viral Upper Respiratory Tract Infections Tract Infections in Children During the Epidemic Growth of Influenza and ARVI","Inclusion Criteria:\n\n1. Outpatients of both genders aged over 6 months and under 3 years.\n2. Clinically confirmed diagnosis of acute viral upper respiratory tract infections (acute pharyngitis, nasopharyngitis, tonsillitis, laryngitis, laryngotracheitis, tracheitis, acute viral respiratory infection of multiple and unspecified localization) during the epidemic growth of influenza and ARVI.\n3. Dry (non-productive) cough lasting at least 24 hours but not more than 72 hours.\n4. Total (day and night) cough severity score of 6 or more.\n5. Availability of a patient information sheet and an informed consent form for participation in the clinical trial signed by one of the patient's parents\u002Fadoptive parents.\n\nExclusion Criteria:\n\n1. Presence of the following diseases at the time of inclusion in the clinical trial:\n\n   1.1 Inflammatory processes in the lower respiratory tract. 1.2 Grade III adenoid hypertrophy. 1.3 Chronic adenoiditis. 1.4 Postnasal drip syndrome. 1.5 Gastroesophageal reflux. 1.6 Bronchial asthma. 1.7 Cystic fibrosis. 1.8 Primary ciliary dyskinesia 1.9 Bronchopulmonary dysplasia 1.10 Malformations of the respiratory and ENT organs 1.11 Other chronic lung diseases. 1.12 Primary\u002Fsecondary immunodeficiency. 1.13 Oncological disease of any localization.\n2. Suspected bacterial infection of any localization, including pneumonia, sinusitis, otitis media.\n3. Allergic rhinitis.\n4. Bronchial obstruction syndrome.\n5. Acute obstructive laryngitis \\[croup\\] and epiglottitis.\n6. Congenital heart defects with hypervolemia in pulmonary circulation.\n7. Acute respiratory failure.\n8. Inflammatory, degenerative, demyelinating diseases of the central nervous system, polyneuropathies, epilepsy.\n9. Exacerbation or decompensation of chronic diseases affecting the patient's ability to participate in a clinical trial.\n10. Presence of allergy\u002Fhypersensitivity to any components of the medicines used in the treatment.\n11. Taking medications listed in the section \"Prohibited Concomitant Therapy\" within 4 weeks prior to inclusion in the study.\n12. Patients whose parents\u002Fadoptive parents, from the investigator's point of view, will not comply with observation requirements during the study or with the administration of study drugs.\n13. Participation in other clinical trials within 3 months prior to inclusion in this trial.\n14. A patient's parent\u002Fadoptive parent is related to on-site research personnel directly involved in the trial, or is the immediate family member of the investigator. 'Immediate family members' mean spouses, parents, children, or siblings, whether related or adopted.\n15. The patient's parent\u002Fadoptive parent is employed by OOO \"NPF \"MATERIA MEDICA HOLDING\", i.e., is an employee of the company, a temporary contract employee, or a designated official responsible for conducting the trial or their immediate family member.","6 Months",{"count":106,"type":21},264,[24],"The goal of this clinical trial is to evaluate the efficacy and safety of liquid dosage form of Rengalin in the treatment of cough in acute viral upper respiratory tract infections infections in children in during the epidemic growth of influenza and ARVI. The main questions it aims to answer are:\n\nInvestigators will compare the liquid dosage form of Rengalin to a placebo (a look-alike substance that contains no drug) to see if Rengalin in the liquid dosage form works for cough in acute viral upper respiratory tract infections in children.\n\nParticipants will:\n\nTake the liquid dosage form of Rengalin or placebo per os 5 ml per administration 3 times a day for 7 days.",[110],"Cough",[110,112,113],"Upper respiratory infection","Children from 6 months to 3 years","2026-02-11",{"date":116,"type":36},"2026-02-13",{"date":118,"type":36},"2025-10-03",{"date":40,"type":21},{"name":42,"class":43},30,""]