Patients suffering from upper respiratory tract infection Respiratory Other diseases of upper respiratory tract
Conditions
Interventions
Patients will be randomised to
1. Intervention group: Influcid® treatment starts immediately after the baseline visit and continues for seven days. There is no run-in period, where patients are monit
Sponsors
Deutsche Homöopathie-Union (DHU)-Arzneimittel GmbH & Co. KG (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects aged 1 to 65 years 2. Diagnosis of upper respiratory tract infection 3. Written informed consent 4. Willingness and ability to comply with all trial procedures
Exclusion criteria
Exclusion criteria: 1. Severe or complicated course of the URTI 2. Signs of acute lower respiratory tract disease 3. Current symptoms mainly induced by other acute ENT (Ear-Nose-Throat) disease 4. Present chronic inflammatory ENT and respiratory tract disease 5. Obstructive anatomic lesions in the nasopharynx 6. Severe heart diseases, HIV-infection, unstable diabetes mellitus, coeliac disease and/or immunosuppression, tuberculosis and lues 7. Severe renal or hepatic dysfunction in past 12 months prior to enrolment 8. Children with congenital anomalies of heart, kidney or liver 9. Any significant alarm symptom within the past 6 months prior to enrolment 10. Evidence of any malignant disease during the past 5 years prior to enrolment 11. 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 £]-hemolytic streptococci (GABHS) 15. Treatment with antibiotics, glucocorticosteroids, immunomodulators, or antihistamines during the past 4 weeks prior to or at enrolment as well as current indication requiring these drugs during the trial 16. Indication for administration of or treatment with antiviral drugs 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 (?d 100 mg per day), during the past 7 days prior to or at enrolment 18. Heavy smoking or known or suspected drug addiction 19. Inadequate contraception, pregnancy, lactation; 20. Participation in another clinical trial during the past 3 months prior to enrolment 21. Incompetence or incapability of understanding nature, meaning and consequences of the trial
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Documentation of symptomatic medication intake 2. Assessment of impairment of daily activity 3. Treatment outcome according to Integrative Medicine Outcomes Scale (IMOS) 4. Satisfaction with treatment according to Integrative Medicine Patient Satisfaction Scale (IMPSS) 5. Tolerability 6. Adverse events Outcomes will be measured at day 4, day 8, and at the study termination visit. | — |
Primary
| Measure | Time frame |
|---|---|
| 1. Fever measurement 2. Symptom assessment via illness-specific quality of life questionnaire (WURSS-21) Outcomes will be measured at day 4, day 8, and at the study termination visit. | — |
Countries
Germany, Russian Federation, Ukraine
Outcome results
None listed