Common cold MedDRA version: 14.0 Level: LLT Classification code 10010106 Term: Common cold System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Kaloba 20mg Filmtabletten
Product Name: EPs® 7630
Product Code: EPs® 7630
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Herbal drug preparation from the roots from Pelargo
Sponsors
Dr. Willmar Schwabe GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Male and female subjects older or equal than 18 years old (2) Written informed consent (3) Subject suffers from common cold (4) Presence of at least two common cold symptoms (5) First common cold symptom started = 72 hours prior to inclusion into the study (6) Subject with willingness and ability to comply with all procedures of the trial. Are the trial subjects under 18? no 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: (1) Obstructive anatomic lesions in the nasopharynx such as nasal polyps, or severe septal deviations (2) Previous surgery (within the last 12 months prior to inclusion into the study) or need for surgery of the nose or paranasal sinuses incl. sinus puncture (3) Presence of any acute respiratory tract disease (e.g. tonsillitis, sinusitis, otitis media, bronchitis, pneumonia) other than common cold (4) Subjects with known or suspected allergic rhinitis (5) Subjects with other explanations of sore throat (e.g. tonsillo-pharyngitis, drugs, aphthous ulcers, candida, etc.) (6) Subjects with previous rheumatic fever within the last 12 months prior to inclusion into the trial (7) Subjects with several previous complications of tonsillitis (quinsy) (8) Chronic lung diseases (e.g. chronic bronchitis, COPD, bronchial asthma, cystic fibrosis, active pulmonary tuberculosis, lung cancer) (9) History of recurrent tonsillitis or otitis media of > 3 episodes during the last 12 months prior to enrolment into the study (10) History of recurrent bronchitis of > 6 episodes during the past 12 months prior to enrolment into the study (11) History of recurrent sinusitis of > 3 episodes during the past 12 months prior to enrolment into the trial or chronic sinusitis (symptoms lasting for > 1 month) (12) Previous (within the last 6 weeks prior to inclusion into the clinical trial) or concomitant treatment with anti-coagulants (13) Concomitant common cold medications that might impair the interpretation of trial results (14) Known or suspected hypersensitivity to the investigational drug (15) Severe cardiovascular disease, unstable diabetes mellitus, or immunosuppression (16) History of renal or hepatic dysfunction (serum creatinine, serum AST, ALT or alkaline phosphatase of >3 times above the upper limit of normal values) at any time during the past 12 months prior to enrolment into the trial (17) Known alcohol or drug abuse (18) Subjects with tendency to bleed, especially nose or gingival bleeding (19) Known gastrointestinal disorders (e.g. gastritis, duodenitis, colitis, gastric ulcer, partial or total gastrectomy, enterectomy, inflammatory bowel disease, celiac disease, symptomatic lactose intolerance, other disorders associated with chronic diarrhea) (20) Females of child-bearing potential without adequate contraception (21) Pregnancy or lactation (22) Subjects participating in another clinical trial at the same time or have taken part in a clinical trial during the last 4 weeks before inclusion into this study (23) Irresponsible subjects or those unable to understand nature, meaning and consequences of the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the present post-marketing study is to gain further information about the safety and treatment outcome with EPs® 7630 film-coated tablets (Kaloba 20 mg Filmtabletten) in adult subjects (= 18 years old) suffering from common cold. ;Secondary Objective: None;Primary end point(s): • Adverse events surveillance • Treatment outcome according to the Integrative Medicine Outcomes Scale (IMOS) as assessed by the investigator and the subject, respectively • Change in individual common cold symptoms (CCS) and total score of CCS from baseline (day 1) to visit 2 and visit 3, respectively, as assessed by the investigator • Change in common cold symptoms (CCS) as rated by the subject in the subject´s diary • Number of subjects who are “not sick” or “very mildly sick” as rated by the subject in the subject´s diary when answering the question “how sick do you feel today?” • Duration of subject´s off work or inability to attend school/college • Need for subject´s treatment with antibiotics during the study period according to the medical decision of the investigator • Use of paracetamol tablets from baseline (day 1) through individual study end • Satisfaction of the subject with the treatment according to the Integrative Medicine Patient Satisfaction Scale (IMPSS) as assessed by the subject in the subject´s diary | — |
Countries
Austria
Outcome results
None listed