Condition category
Respiratory
Date applied
19/10/2010
Date assigned
09/11/2010
Last edited
11/08/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Manuela Thinesse-Mallwitz

ORCID ID

Contact details

Fäustlestraße 3
München
80339
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

09-NI-EP-001

Study information

Scientific title

Efficacy, safety and tolerability of Influcid® tablets in patients (1 to 65 years old) suffering from upper respiratory tract infections with flu-like symptoms

Acronym

INFI

Study hypothesis

No 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

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)

Study design

Randomised international multicentre open controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please contact the sponsor (contact details see below) to request a patient information sheet

Condition

Patients suffering from upper respiratory tract infection

Intervention

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 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 type

Other

Phase

Phase IV

Drug names

Primary outcome measures

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.

Secondary outcome measures

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.

Overall trial start date

15/11/2010

Overall trial end date

30/04/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

520

Participant 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

Recruitment start date

15/11/2010

Recruitment end date

30/04/2011

Locations

Countries of recruitment

Germany, Russian Federation, Ukraine

Trial participating centre

Fäustlestraße 3
München
80339
Germany

Sponsor information

Organisation

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

Sponsor details

Ottostraße 24
Karlsruhe
76227
Germany

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes