CTRI/2026/03/105404招募中不适用
Safety, Tolerability and Efficacy Evaluation of Cold Relief Roll-on in Improving Symptoms of Cold in Infants and Young Children
Mother Sparsh Baby Care Pvt. Ltd.1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年3月16日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
This study aims at evaluating the safety, tolerability and efficacy of the test product in relieving the symptoms and discomforts associated with cold. Subjects with acute cold symptoms with nasal and/or chest congestion for less than or equal to 48hrs will be enrolled in the study. Post baseline assessment, product will be applied on the clothes and skin and tracked for change in symptom severity at specified timepoints upto a maximum of 10 days for each subject.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 3.00 Month(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects between the ages 3 months to 12 years of either sex.
- •Subjects with acute cold symptoms with nasal and/or chest congestion present for less than or equal to 48 hours.
- •Subjects with at least mild-moderate nasal or chest congestion.
- •Mothers or guardians who agrees to participate their child in this trial and signs a written consent form before the test begins.
排除标准
- •Subject with severe systemic illness, fever unstable chronic conditions, immunodeficiency, birth defects, anomalies, or other serious comorbidities that could interfere with study participation or safety.
- •Subjects with known allergy or hypersensitivity to any ingredient in the study product, or a history of asthma triggered by topical aromatic products.
- •Subjects with skin conditions at application site, open wounds, eczema flare, rash, burns, or infection that may interfere with topical application or assessments.
- •Subjects using prohibited medications (topical or systemic decongestants, corticosteroids, antihistamines, or other cold medications) within 24-48 hours prior to enrolment.
- •or those judged by the investigator to be inappropriate for participation in the trial.
研究者
Dr Namana
BGS Global Institute of Medical Sciences
研究点 (1)
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