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.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- NUTRIN GmbH
- 入组人数
- 267
- 试验地点
- 1
- 主要终点
- Cistus Plus Infektblocker Lozenges, Gum Arabic Lozenges and Cistus Echinacea Lozenges for throat infection/pharyngitis
研究概览
简要总结
A throat infection, sometimes called pharyngitis, can be either a bacterial or a viral infection leading to inflammation of the tissues of the throat that causes redness, pain and swelling of the walls or structures of the throat. The throat, or pharynx, is the tube-like structure that carries both food to the oesophagus and air to your windpipe (called the larynx). Infective agents of the throat most often enter through the mouth or nose. Many of these infections are viral; others can be caused by bacteria (such as Streptococcus pyogenes, or group A Streptococcus). Symptoms of throat infection most commonly include pain and a sensation of heat in the throat or pharynx. Viral Infections account for approximately 70% of all pharyngitis. Rhinovirus is the most common cause of viral infection. The other common causes of viral infection in descending order are coronavirus, adenovirus, parainfluenza, and influenza virus. Viral infections are more common during the winter months with the exception of adenoviruses which occur year round. Viral pharyngitis is spread through similar mechanism as other viral infections. Hand to mouth contact, contact with oral secretions and sharing common utensils all contribute to viral spread. Prevention of the spread of disease is based on frequent hand washing and Clinical symptoms of different viruses are more prevalent during certain seasons. Coryza, conjunctivitis, malaise or fatigue, hoarseness, and low-grade fever suggest the presence of viral pharyngitis.Subjects with viral pharyngitis can also have atypical symptoms such as mouth breathing, nausea, vomiting, abdominal pain and diarrhoea.
A throat lozenge (also known as a cough drop or cough sweet) is a small, typically medicated tablet intended to be dissolved slowly in the mouth to temporarily stop coughs, lubricate, and soothe irritated tissues of the throat (usually due to a sore throat).On a clinical level, Cistus is beneficial in respiratory infections mainly caused by virus and bacteria. Cistus-Infektblocker are fruity sugar-free lozenges with rock rose extract, elderberry extract and gum arabic. Like a protective shield, the polyphenols (tannins) from the plant extract (Cistus / Echinacea extract) spread over the oral and pharyngeal mucous membranes and thus help to ward off viruses and bacteria before they enter the body. Due to the physical mode of action, there is no development of resistance. These standardized special extracts enable a high effective dosage of polyphenols. Gum arabic relieves dry coughs
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Subjects of either sex
- •Male or female aged from18 to 65years
- •Patient with sore throat due to viral or bacterial infection.
- •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.
- •If female of childbearing potential, must be willing to practice an acceptable form of birth control for the duration of the study.
- •Are able to give written informed consent in a manner approved by the Institutional Ethics Committee and comply with the requirements of the study.
- •Are willing to avoid participation in any other interventional clinical trial for the duration of this study.
- •Compliance by the patient seems guaranteed, and the patient seems to be able to understand and complete the patient diary.
排除标准
- •Severe respiratory tract infection (pneumonia, bronchitis or laryngitis)
- •Oro-pharyngeal paresthesia or mycosis
- •Severely traumatized and/or very severe oromucosal inflammation
- •Tonsillo-pharyngectomy
- •Peritonsillar abscess
- •Allergic to Cistus, Echinacea, elderberry, gum Arabic
- •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)
- •Any anti-inflammatory drugs intake by systemic route within 12 hours before randomization
- •Any paracetamol intake within 6 hours before randomization
- •Any cold medication (decongestant, antihistamine, expectorant, antitussive) within 6 hours before randomization
- •Any topical throat medication intake containing or not a local oral anesthetic such as lozenge, spray, mouth rinse within 4 hours before randomization
- •Heavy smokers (>20 cigarettes/day).
结局指标
主要结局
Cistus Plus Infektblocker Lozenges, Gum Arabic Lozenges and Cistus Echinacea Lozenges for throat infection/pharyngitis
时间窗: Baseline and Day 05
次要结局
- To assess the safety and tolerability(Baseline and Day 05)
- physical Layer effect of Lozenges(Baseline)
