Diagnosed upper respiratory tract infection (URTI) with presence of the following symptoms for equal or less than for 24 hours : a)Fever (axillary temperature >= 37.5°C) and b)At least one upper respiratory tract symptom: either i) one nasal symptom or ii) one pharyngeal symptom or iii) cough and c) at least one general symptom: either i) feeling tired or ii) weakness or iii) body aches or iv) for children only: irritable / whiny or less active. MedDRA version: 12.1 Level: LLT Classificatio
Conditions
Interventions
Trade Name: Nisylen (Tabletten)
Pharmaceutical Form: Tablet
Current Sponsor code: Aconitum trit. D3
Other descriptive name: ACONITUM
Concentration unit: mg milligram(s)
Concentration type: equal
Con
Sponsors
Deutsche Homöopathie-Union, DHU-Arzneimittel GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females aged from 1 to 65 years; 2. Diagnosed URTI with presence of the following symptoms for equal or less than for 24 hours: a) Fever (axillary temperature = 37.5°C) and b) At least one upper respiratory tract symptom: either i) one nasal symptom (plugged nose, runny nose, sneezing) or ii) one pharyngeal symptom (scratchy throat, sore throat, pharynx hyperemia) or iii) cough (ordinary cough without suspicion of acute lower respiratory tract disease) and c) at least one general symptom: either i) feeling tired or ii) weakness or iii) body aches or iv) for children only: irritable / whiny or less active. 3. Written informed consent according to the applicable law; 4. Willingness and ability to comply with all procedures of the trial. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects presenting any of the following criteria will not be included in the study: 1. Severe or complicated course of the URTI (e.g. shortness of breath, dyspnoea, tachypnea, hypoxia, central nervous system (CNS) findings, severe dehydration, renal failure, multi-organ failure, septic shock, musculoskeletal (rhabdomyolysis) and cardiac (myocarditis) complications); 2. Signs of acute lower respiratory tract disease (e.g. bronchiolitis, bronchitis, pneumonia); 3. Current symptoms mainly induced by other acute ENT (Ear-Nose-Throat) disease such as tonsillitis, sinusitis, otitis media; 4. Any present chronic inflammatory ENT and respiratory tract disease (e.g. allergic rhinitis, bronchitis, bronchial asthma, obstructive pulmonary disease (COPD), cystic fibrosis and adenoidal hypertrophy); 5. Obstructive anatomic lesions in the nasopharynx such as nasal polyps, tumours or severe septal deviations; 6. Patients with severe heart diseases, HIV-infection, unstable diabetes mellitus, coeliac disease and/or immunosuppression and only for adolescents-adults tuberculosis as well as lues at any stage; 7. Patients with severe renal or hepatic dysfunction at any time during the past 12 months prior to enrolment into the trial; 8. Children with congenital anomalies of heart, kidney or liver; 9. Any significant alarm symptom within the past 6 months prior to enrolment into the trial, e.g. unintentional weight loss, or any other sign indicating serious or malignant disease; 10. Evidence of any malignant disease during the past 5 years prior to enrolment into the trial; 11. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption; 12. Hypersensitivity to any of the ingredients and/or excipients of Influcid; 13. Hypersensitivity to any of the ingredients and/or excipients as well as any known contraindications to the symptomatic treatment defined in this protocol; 14. Positive rapid test for group A ß-hemolytic streptococci (GABHS); 15. Treatment with antibiotics, glucocorticosteroids, immunomodulators (including drugs contraining probiotics), or antihistamines during the past 4 weeks prior to or at enrolment into the trial as well as current indication requiring these drugs during the trial; 16. Indication for administration of or treatment with antiviral drugs (e.g. oseltamivir); 17. Treatment with any antipyretics, nasal decongestants, expectorants and/or any other cold medication or measure for relief of URTI e.g. local anesthetics, anti-inflammatory drugs, antitussiva, homeopathic drugs, nutritional supplements or drugs containing zinc, echinacea, garlic or vitamin C (³ 100 mg per day), during the past 7 days prior to or at enrolment into the trial; 18. Heavy smoking or known or suspected drug addiction incl. alcohol abuse; 19. Women of childbearing potential without adequate contraception or women, who want to become pregnant, are pregnant or breast-feeding; 20. Participation in another clinical trial during the past 3 months prior to enrolment into the trial; 21. For patients = 18 years: Incompetence or incapability of understanding nature, meaning and consequences of the trial; For patients < 18 years: Irresponsible parents or their legal representatives unable to understand nature, meaning and consequences of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. Fraction of patients with symptoms alleviation at day 4 of the study. Symptoms alleviation is defined as: - Absence of fever (axillary temperature = 37.2°C) and - Absence or very mild degree of the symptoms assessed by Wisconsin Upper Respiratory Symptom Survey 21 (WURSS-21). Fever will be measured 3-times daily by the patient (or in case of children by their parents) at home. Mean value covering last 24 hours will be basis for this definition. Absence or very mild degree of symptoms is defined as answer to question “How sick do you feel today?” with “0” (not sick) or “1” (very mildly) for both assessments at day 4 (WURSS-21 is filled in twice daily by the patient or in case of children by their parents at home). ;Secondary Objective: 2. Time to symptoms alleviation; 3. Fraction of patients with symptoms alleviation as defined for primary objective at study day 2, 3, 5, etc. until end of study as well as fraction of subjects who maintained symptoms alleviation at the different time points (day 3, 4, 5, etc); 4. Time to return to normal daily activity; 5. Time to resolution of individual symptoms (analyzed via WURSS-21); 6. Area under the curve (AUC) describing severity and course of the infection; 7. Total amount, amount per day and duration of Paracetamol, Ambroxol and Oxymetazoline consumption; 8. Fraction of patients who must be withdrawn from the study due to prohibited medication; 9. Treatment outcome according to Integrative Medicine Outcomes Scale (IMOS); 10. Satisfaction with treatment according to Integrative Medicine Patient Satisfaction Scale (IMPSS); 11. Tolerability of treatment; 12. Incidence of complications, adverse events, and adverse drug reactions. ;Primary end point(s): Number of responders (patients without fever (axillary temperature = 37.2°C) and without symptoms or with very mild degree of the symptoms only as assessed by item 1 of WURSS-21) at day 4. | — |
Countries
Germany
Outcome results
None listed