CTRI/2022/05/042564招募中4 期
Open Label, Comparative, Randomized, clinical study to evaluate efficacy and safety of Curkey Pastilles when taken with standard treatment in acute, viral, uncomplicated, upper respiratory tract infection and in combination with standard antibiotic in acute uncomplicated bacterial upper respiratory tract infection and compared with standard antibiotic treatment alone in children of 7-12 years of age.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
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.Parents or legal guardians willing to sign written informed consent form for the child and child willing to sign assent form for participation
- •2.Children and parents / guardians who agree to comply with study requirement and schedule Diagnosed uncomplicated acute infectious and inflammatory diseases of the pharynx, accompanied by a sore throat;
- •3.Should be more than 7 years of age and less than or equal to 12 years of age at the time of inclusion into the study;
- •4.Onset of first symptoms of the uncomplicated acute infectious and inflammatory diseases of the pharynx (pharyngitis and/or tonsillitis) less than 48 hours prior to inclusion into the study;
- •5.Tonsillopharyngitis Severity Score (TSS) ââ?°Â¥ 5 (TSS consist of sore throat, dysphagia, secretions and erythema). Baseline modified Centor score ââ?°Â¤ 2 (total score)
- •6.Subjects with throat symptoms and fever on patient reported outcome measures: sore throat pain rated more than or equal to 66 mm on the Sore Throat Pain Intensity Scale (STPIS) and fever more than 98.60 F
排除标准
- •1.Use of analgesics within <12 hours prior to the study start or/and inability to cancel them during the study;
- •2.Use of antibiotics within <48 hours prior to the study start or/and inability to cancel them during the study;
- •3.Use systemic or inhaled corticosteroids within ââ?°Â¤1 months prior to the study start and planned therapy of them during the study (besides skin means).
- •4.Subjects presenting with bronchitis, severe pharyngitis, severe tonsillitis
- •5.Highly infected and inflamed tonsillitis pediatric patients.
- •6.Subjects with any other chronic illness such as asthma, heart blocks, any congenital anomaly
- •7.Subjects having sensitivity reaction to components of CurkeyïÆ?¢ or antibiotics suggested in the reference group.
- •8.Subjects will be ineligible if they displayed confounding features of URTI: mouth breathing which causes throat drying, coughing which causes throat discomfort, or any disease that could compromise respiratory function.
- •9.Subjects will be also ineligible if they had a history of allergic reaction or hypersensitivity to aspirin or other nonsteroidal anti-inflammatory drugs, or any gastrointestinal, hepatic, or renal dysfunction.
- •10.Subjects will be excluded if they had to use any throat lozenge, throat spray, cough drop, or menthol-containing product within one hour prior to study screening, used any ââ?¬Ë?cold medicationââ?¬• or immediate release analgesic within the previous four hours, used any sustained-release analgesic within the previous 12 hours, taken an antibiotic for an acute disease within 24 hours, or any quinolone antibiotic or inhaled therapy in the previous week.
研究者
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