A study to assess the efficacy of a combination of natural plant extracts in natural colds.

Procter & Gamble Technical Centres Limited0 sites210 target enrollmentDecember 5, 2005

ConditionsCommon Cold (nasopharyngitis), Upper Respiratory Tract Infection MedDRA version: 8.0 Level: PT Classification code 10028810

DrugsKan Jang Ibuprofen Caplets 400mg Piriton Allergy Tablets

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Common Cold (nasopharyngitis), Upper Respiratory Tract Infection
Sponsor: Procter & Gamble Technical Centres Limited
Enrollment: 210
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 5, 2005

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Procter & Gamble Technical Centres Limited

Eligibility 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;

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;