A clinical trial comparing the safety and effectiveness of hexylresorcinol lozenges and combination product of hexyl resorcinol and benzalkonium chloride against placebo in relieving throat pain due to upper respiratory tract infectio
- Conditions
- Health Condition 1: null- Sore Throat due to Upper Respiratory Tract Infection
- Registration Number
- CTRI/2012/02/002417
- Lead Sponsor
- Remedia Therapeutics Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
1. Patients having sore throat associated with upper respiratory tract infection, diagnosed clinically as pharyngitis.
2. Female and male patients between the age of 18 and 80 years (inclusive of both).
3. Willing to give written informed consent.
4. The throat pain intensity is rated as at least moderate on the Verbal Rating scale (VRS) by the patient.
5. Compliance by the patient seems guaranteed, and patient seems to be able to understand and complete the subject diary card.
6. Willing to remain at the doctors practice for the initial 3 hours following the first intake of study medication or willing to comply with the documentation requirement of completing the subject diary card.
7. Willing to return for the end of study visit.
1. Patients with symptoms of primary bacterial pharyngitis or bacterial secondary infection as assessed clinically.
2. First indication of symptoms of acute pharyngitis (e.g. sore throat) occurred more than 2 days ago.
3. Patients who in the past week required antibiotics for sore throat associated with upper respiratory tract infection.
4. Patients who in the past week required or during the study will require treatment with any of the following: steroids for oral, inhaling or topical application, expectorants or antitussives.
5. Patients who have used lozenges or any other topical throat treatment 2 hours prior to the screening, any sore throat medication containing a local anesthetic 04 hours prior to the screening, any short acting analgesic 6 hours prior to the screening and any long acting or slow-release analgesic 24 hours prior to the screening.
6. Female patients of child-bearing potential who are pregnant or currently breast feeding, or not practicing an acceptable method of birth control.
7. History of fructose intolerance or any metabolic disorder relating to glucose / sucrose ingestion.
8. Patients with known diabetes mellitus.
9. Patients with mouth breathing as a result of nasal congestion.
10. Known hypersensitivity to hexylresorcinol or benzalkonium chloride or any auxiliary substances contained in the lozenges.
11. Any existing malignancy.
12. Chronic smokers, tobacco chewers, alcoholics and those with a history of drug abuse.
13. Any clinical condition which, in the opinion of the investigator would not allow safe completion of the study and safe administration of study medication.
14. Patients who will be unable to comply fully with the protocol requirements.
15. Any investigational therapy within 30 days prior to randomization into this study.
16. Patients who are unable to comply with documentation required in the diary card for the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method