CTRI/2012/08/002927已完成未知
An open label, proof of concept study to evaluate the safety, efficacy and tolerability of Throat spray (LPOTC002-11) for relief of sore throat/throat pain in subjects with acute pharyngitis.
aila Pharmaceuticals Pvt Ltd0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Female and male subjects between the age of 18 and 65 years.
- •2.Sore throat due to acute pharyngitis (not more than 72 hours)
- •3.The throat pain intensity is rated at least moderate on the verbal rating scale
- •4.Willingness to remain at the study centre for two hours following the first dose of study medication and return three to five days later.
- •5.Willing to take nothing by mouth except study medication for two hours following the first application of study product. Subjects must also not smoke during this time period.
- •6.Females of childbearing potential must agree to use a medically approved form of birth control and have a negative urine pregnancy test result throughout the study. Female subjects of non childbearing potential must be amenorrheic for at least 1 years or had a hysterectomy and/or bilateral oophorectomy
- •7.The subject has provided written informed consent prior to any study-related procedures.
排除标准
- •1.Female subjects who are pregnant or lactating
- •2.First indication of symptoms of acute pharyngitis (e.g. sore throat) occurred more than 3 days ago.
- •3.Subjects who suffered from acute viral or bacterial pharyngitis in the past 4 weeks.
- •4.Subject who have taken antibiotics, analgesics, anti-inflammatory agents, steroids for oral, inhaling or topical application expectorants or antitussives in the past week or will require these treatments during the study. No physical therapy (e.g. throat compress, throat rinsing) may be applied during the trial.
- •5.Subjects with mouth breathing as a result of nasal congestion.
- •6.Known hypersensitivity to curcuminoids, olive leaf extracts or any excipients contained in the throat spray.
- •7.Cough that causes throat discomfort
- •8.Active pulmonary disease such as bronchopneumonia
- •9.Use of any throat lozenge, throat spray, cough drop, menthol-containing product, or any product with demulcent properties within last 2 hours
- •10.Use of any cold medication (e.g. decongestant, antihistamine, expectorant, anti-tussive) within last eight hours
- •11.Use of an antibiotic for an acute illness within last 24 hours
- •12.Use of inhaled steroids or beta-agonists on a continuous basis during the last week
- •13.Existing tumour condition currently under treatment.
- •14.Alcohol, and/or drug abuse.
- •15.Any clinical condition which, in the opinion of the investigator would not allow safe completion of the protocol and safe administration of trial medication.
- •16.Any investigational therapy within 30 days prior to the enrolment
研究者
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