Common Cold (nasopharyngitis), Upper Respiratory Tract Infection MedDRA version: 8.0 Level: PT Classification code 10028810
Conditions
Interventions
Trade Name: Kan Jang
Pharmaceutical Form: Tablet
Current Sponsor code: Siberian Ginseng
Other descriptive name: Acanthopanax senticsus
C
Sponsors
Procter & Gamble Technical Centres Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Subject is male or female aged at least 18 years, and in good health; b) Female subjects of child bearing potential have a negative urine pregnancy test and are currently using an acceptable method of birth control, at the discretion of the Investigator; c) Subject thinks that he/she is coming down with a cold, with the first signs of the cold occurring no more than 36 hours prior to Visit 1; d) Subject has a symptom score of 1 or greater for either sore/scratchy throat, runny nose or stuffy/congested nose at Visit 1; e) Subject has a value of 7 or less for the sum of the severity scores across the symptoms assessed at Visit 1 (sore/scratchy throat, runny nose, stuffy/congested nose, cough, tired/run down feeling, chilliness, sneezing, and headache); f) Subject has read, signed, dated, and received a copy of the Informed Consent prior to initiation of the study procedures; g) Subject agrees to avoid alcohol starting at enrollment (Visit 1) and continuing through Day 7; h) Subject agrees to consume 3 or less cups of coffee or other caffeinated beverages per day starting at enrollment (Visit 1) and continuing through Day 7; i) Subject agrees to refrain from taking any products including vitamins, dietary supplements, and homeopathic preparations intended to prevent, intervene in, or treat cough/colds/flu starting at enrollment (Visit 1) and continuing through Day 7 (e.g., those containing vitamin C, zinc, Echinacea); use of a daily multivitamin is allowed; j) Subject agrees to refrain from taking any products including vitamins, dietary supplements, and homeopathic preparations that are intended for sinus/allergy/pain relief starting at enrollment (Visit 1) and continuing through Day 7 (e.g., those containing antihistamines, anticholinergics, decongestants, analgesics); use of low dose aspirin (81-100 mg/day) for cardiac prophylaxis and a daily multivitamin are allowed; 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a) Have a known hypersensitivity or are allergic to any component of the test products (see section 3.4.3); b) Are breast-feeding, pregnant, or attempting to become pregnant; c) Have had nasal or sinus surgery in the last 2 years or have a clinically significant abnormality of the upper respiratory tract (e.g., chronic nose bleeds, nasal polyp, irreversible nasal mucosal hypertrophy, severe nasal septal deviation); d) Have had a malignancy within the last two years; e) Have or have ever had a respiratory disease (e.g., chronic rhinitis, sinusitis, asthma or reactive airway disease, chronic bronchitis, pneumonia, persistent or chronic cough, emphysema, breathing problems, excessive phlegm or mucus), cardiovascular disease (e.g., myocardial infarction, hypertension), gastrointestinal disease (e.g., hyperacidity, gastrointestinal ulcer, obstruction of bile passages, gall bladder obstruction, gall stones), endocrine disease (e.g., diabetes, thyroid disease, including an overactive thyroid gland), ophthalmic disease (e.g., glaucoma), neurological disease (e.g., epilepsy), urological disease/condition (e.g., an enlarged prostate gland), or hepatic, renal, hematological, or immunological disease; f) Experience frequent headaches/migraines (3 or more times per week); g) Are currently taking medicines containing phenytoin, heparins, antiplatelet agents, thrombolytic agents, anticoagulants, or medicines to treat anxiety or sleep disorders; h) Have taken MAOI (monoamine oxidase inhibitor) drugs within 14 days of Visit 1; i) Have taken any products including vitamins, dietary supplements, and homeopathic preparations intended to prevent, intervene in, or treat cough/colds/flu within 24 hours of Visit 1 (e.g., those containing vitamin C, zinc, Echinacea); use of a daily multivitamin is allowed; j) Have taken any products including vitamins, dietary supplements, and homeopathic preparations that are intended for sinus/allergy/pain relief within 24 hours of Visit 1 (e.g., those containing antihistamines, anticholinergics, decongestants, analgesics); use of low dose aspirin (81-100 mg/day) for cardiac prophylaxis and a daily multivitamin are allowed; k) Are currently experiencing symptoms of respiratory or seasonal allergy; l) Have a temperature greater than 38.3° C at Visit 1; m) Have smoked cigarettes for more than 20 pack/day years (number of pack/day years is number of years smoked times average number of packs smoked per day); n) Have received any investigational drug or participated in a clinical trial within 4 weeks of Visit 1 or are currently enrolled in another investigational study; o) Are related to any study personnel; p) Have a condition or have taken / are currently taking a medication that the Investigator and/or designee believes could jeopardize the safety of the subject, interfere with the evaluation of the study, or confound the interpretation of the study results, or otherwise be considered unsuitable for entry into the study by the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effectiveness of a combination of natural plant extracts on the severity of the common cold relative to a placebo control when used within 36 hours of the first signs of the cold. ;Secondary Objective: To assess the effectiveness of an active control (ibuprofen plus chlorphenamine maleate) versus the placebo control.; Primary end point(s): The primary comparison of interest for the study will be that of patients taking Kan Jang (PR1) and Curcumin (PR4) concomitantly versus placebo. The secondary comparison will be that of patients taking Ibuprofen (PR2) and Chlorphenamine (PR3) concomitantly. In both cases the primary end point will be the patient assessment of severity of the cold, which will be a summation of the following severity scores; sore/scratchy throat severity, runny nose severity, stuffy/congested nose severity, cough severity, Tired / Run-down Feeling severity Difficulty sleeping severity. | — |
Countries
United Kingdom
Outcome results
None listed