CTRI/2026/03/105403招募中不适用
Safety, Tolerability and Efficacy Evaluation of Colic Relief Stomach Roll-on in Improving/Reliving Symptoms of Colic, Indigestion and Constipation in Newborns and Infants
Mother Sparsh Baby Care Pvt Ltd1 个研究点 分布在 1 个国家目标入组 50 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
- 50
- 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 colic, indigestion and constipation. Subjects with recurrent and prolonged periods of crying, fussing, or irritability reported by caregivers associated with colic discomfort as per parental judgement will be enrolled in the study. Post baseline assessment, product will be applied on the stomach around the naval region and tracked for change in symptom severity at specified timepoints upto a maximum of 3 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
- 7.00 Day(s) 至 1.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects between the age group of 1st week to 1 year (of both genders).
- •Recurrent and prolonged periods of crying, fussing, or irritability reported by caregivers associated with colic discomfort as per parental judgement.
- •Subjects with specific FLACC score.
- •Subjects with specific IGSQ score.
- •Parents or guardians willing to let their new born or infants participate in this trial and sign a written consent form before the trial begins.
排除标准
- •Subjects above 1 year of age.
- •Subjects with chronic colic discomfort, abdominal colic necessitating emergency intervention, excretory system disorders, known congenital or metabolic anomalies or any chronic illness, allergies necessitating medications which can impact the study or subject judged by the investigator to be inappropriate for this trial.
- •Subjects receiving formula for specific medical purposes.
- •Subjects not willing to stop the use of other tummy oil or any medication for this indication during study period.
- •Subjects whose parents or guardians hesitant to sign the informed consent form or abiding by the study protocol.
研究者
Dr Namana
BGS Global Institute of Medical Sciences
研究点 (1)
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