"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."

Inzpera Healthsciences Limited2 个研究点分布在 1 个国家目标入组 84 人开始时间: 2022年5月17日最近更新: 2022年7月13日

试验速览

阶段: 4 期
状态: 招募中
发起方: Inzpera Healthsciences Limited
入组人数: 84
试验地点: 2
主要终点: Efficacy will be evaluated based on the following parameters comparing intra-patients for Group A and the two treatment arms from baseline to end of treatment for Group B

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Upper respiratory tract infections (URTIs) are believed to be one of the main reasons for visits to the pediatrician and are considered the most common reason for absenteeism from school. URTIs include but are not limited to laryngitis, pharyngitis, tonsillitis and acute rhinitis. Most URTIs have a viral origin but may also be caused by bacteria. Allergies, air pollution, shouting or speaking loudly can cause mild inflammation of the respiratory tract, which may lead to chronic disorders if not treated early.

Viral URTIs resolve spontaneously and do not require antimicrobial intervention unless complicated by acute otitis media with effusion, tonsillitis, sinusitis, and lower respiratory tract infection. Group A beta-hemolytic streptococcus (GABHS) accounts for 15 to 30 percent of cases of acute pharyngitis in children. Though URTIs are generally self-limiting, antibiotics are often prescribed to prevent suppurative and non-suppurative complications. However, an alarming rise in antibiotic resistance in past decades has prompted research in alternative therapies. Traditional remedies like gargling with salt water or consumption of turmeric milk are recommended butare not child friendly and provide temporary relief. It is thus prudent to identify solutions that shall provide quick and localized symptomatic relief with minimal side effects in a child friendly formulation.

Curcuma longa rhizome has been traditionally used as antimicrobial agent1. Severalstudies have reported the broad-spectrum antimicrobialactivity for curcumin including antibacterial, antiviral, antifungal,and antimalarial activities. Because of the extendedantimicrobial activity of curcumin and safety property evenat high doses (12 g/day) assessed by clinical trials in human,it was used as a structural sample to design the new antimicrobialagents with modified and increased antimicrobialactivities through the synthesis of various derivatives relatedto curcumin

研究设计

研究类型: Interventional
分配方式: Other
盲法: Open Label

入排标准

年龄范围: 7.00 Year(s) 至 12.00 Year(s)（—）
性别: All

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) â‰¥ 5 (TSS consist of sore throat, dysphagia, secretions and erythema).
•Baseline modified Centor score 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 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 Curkeyïƒ¢ 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 â€˜cold medicationâ€™ 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.

结局指标

主要结局

Efficacy will be evaluated based on the following parameters comparing intra-patients for Group A and the two treatment arms from baseline to end of treatment for Group B