Influcid® in Feverish Infections

ISRCTN ISRCTN60440500
DOI https://doi.org/10.1186/ISRCTN60440500
Secondary identifying numbers 09-NI-EP-001
Submission date
19/10/2010
Registration date
09/11/2010
Last edited
11/08/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Manuela Thinesse-Mallwitz
Scientific

Fäustlestraße 3
München
80339
Germany

Study information

Study designRandomised international multicentre open controlled clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please contact the sponsor (contact details see below) to request a patient information sheet
Scientific titleEfficacy, safety and tolerability of Influcid® tablets in patients (1 to 65 years old) suffering from upper respiratory tract infections with flu-like symptoms
Study acronymINFI
Study objectivesNo formal study hyothesis has been formulated. The data will be analyzed exploratively The study has been set up to evaluate systematically the efficacy and tolerability of Influcid® when used in addition to standard symptomatic treatment in comparison to standard symptomatic treatment alone.
Ethics approval(s)1. Ukraine: The Central Ethics Commission of Ministry of Healthcare of Ukraine approved on the 16th of September 2010 (ref: 5.12-1109/KE)
2. Russian Federation: The Ethics Committee of Federal Service of Oversight in the Field of Healthcare and Social Development approved on the 25th of August 2010 (ref: 40232)

Added 10/11/10:
3. Germany: The Ethics Committee of the Bavarian State Medical Association (Ethikkommission der Bayrischen Landesärztekammer) approved on the 26th of October (ref: 10068)
Health condition(s) or problem(s) studiedPatients suffering from upper respiratory tract infection
InterventionPatients 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 monitored before they are receiving Influcid®.
2. Control group: Symptomatic medication only, no placebo.

All study patients (control-group as well as Influcid®-group) will receive symptomatic medication provided at the discretion of the investigator depending on the symptoms of the patient. Symptomatic medication can be administered throughout study duration.

Patients will be followed for 14 days in total.
Intervention typeOther
Primary outcome measure1. 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.
Secondary outcome measures1. 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.
Overall study start date15/11/2010
Completion date30/04/2011

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants520
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment15/11/2010
Date of final enrolment30/04/2011

Locations

Countries of recruitment

  • Germany
  • Russian Federation
  • Ukraine

Study participating centre

Fäustlestraße 3
München
80339
Germany

Sponsor information

Deutsche Homöopathie-Union (DHU)-Arzneimittel GmbH & Co. KG (Germany)
Industry

Ottostraße 24
Karlsruhe
76227
Germany

ROR logo https://ror.org/0451ek747

Funders

Funder type

Industry

Deutsche Homöopathie-Union (DHU)-Arzneimittel GmbH & Co. KG (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan
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