A single blind, randomized, comparative prospective clinical study to evaluate the efficacy of a Cistus Plus Infektblocker, Gum Arabic lozenges, and Cistus Echinacea Lozenges in patients with sore throat due to bacterial or viral infection.

TRIN GmbH0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Subjects of either sex
•2. Male or female aged from18 to 65years
•3. Patient with sore throat due to viral or bacterial infection.
•4. Are free of any disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events.
•5. If female of childbearing potential, must be willing to practice an acceptable form of birth control for the duration of the study.
•6. Are able to give written informed consent in a manner approved by the Institutional Ethics Committee and comply with the requirements of the study.
•7. Are willing to avoid participation in any other interventional clinical trial for the duration of this study.
•8. Compliance by the patient seems guaranteed, and the patient seems to be able to understand and complete the patient diary.

•1. Severe respiratory tract infection (pneumonia, bronchitis or laryngitis)
•2. Covid-19
•3. Oro-pharyngeal paresthesia or mycosis
•4. Severely traumatized and/or very severe oromucosal inflammation
•5. Tonsillo-pharyngectomy
•6. Peritonsillar abscess
•7. Allergic to Cistus, Echinacea, elderberry, gum Arabic
•8. Long term use (>= 3 times per week within the last month or regular intake within the last
•3 months before randomization) of anti-inflammatory drugs- Any long-acting or slow release analgesic intake including Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)within 24 hours before randomization (e.g. piroxicam or naproxen)
•9. Any anti-inflammatory drugs intake by systemic route within 12 hours before randomization
•10. Any paracetamol intake within 6 hours before randomization
•11. Any cold medication (decongestant, antihistamine, expectorant, antitussive) within 6 hours before randomization
•12. Any topical throat medication intake containing or not a local oral anesthetic such as lozenge, spray, mouth rinse within 4 hours before randomization
•13. Heavy smokers ( >20 cigarettes/day)

发起方

TRIN GmbH