CTRI/2023/11/060337Other (Terminated)不适用
To evaluate the efficacy of digestive enzymes, carminatives & probiotics in the management of infantile colic in a tertiary care hospital in South India
Jhaver Research Foundation1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年12月10日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- Other (Terminated)
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- After a 5-day study, the primary outcome will be assessed by the clinical response which is defined as the percentage of infants achieving a reduction in the daily average crying time 50%
研究概览
简要总结
The study titled “ To evaluate the efficacy of digestive en, carmanatives & Probiotics in the management of infantile colic in a Tertiary care hospital in South India†is Terminated and recruitment not done.
Reason: The sponsor insisted on sharing of raw data for publication which can promote the product (which turns it as regulatory trial). The IEC of Chengalpattu medical college is registered for conducting of Academic trials only.
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 1.00 Year(s)（—）
- 性别
- All
入选标准
- •Infants (age 3 months to 1 year) fulfilling the Rome-IV diagnostic criteria for infantile colic with no evidence of acute/ chronic illness.
- •Rome-IV diagnostic for clinical research purposes, diagnosis of infantile colic also includes both of the following.
- •Caregiver reports infant has cried or fussed for three or more hours per day during three or more days in 7 days in a telephone or face-to-face screening interview; and
- •Total 24-h crying plus fussing in the selected group of infants is confirmed to be three h or more when measured by at least one prospectively kept 24-h behaviour diary.
- •Parents who report their infant crying excessively must be screened on an outpatient basis.
排除标准
- •Infants born before completing 34 weeks of gestation or birth weight < 2500 g and inadequate weight gain (< 125 g/wk.).
- •Infants with known gastrointestinal disorders, previous abdominal surgery, known galactosemia or diabetes mellitus will be excluded from the study.
- •Infants with severe dehydration.
- •Infants with known immunocompromising morbidities.
- •Infants with severe acute malnutrition.
- •Infants with chronic or severe respiratory, cardiovascular, central nervous system, endocrine and other gastrointestinal disorders on clinical examination.
- •Infants with cystic fibrosis.
结局指标
主要结局
After a 5-day study, the primary outcome will be assessed by the clinical response which is defined as the percentage of infants achieving a reduction in the daily average crying time 50%
时间窗: 5-days
次要结局
- 1. After a 5-day study, the secondary outcome will be assessed by the occurrence of adverse events (Milk regurgitation, vomiting, diarrhoea, constipation) following the administration of digestive enzymes, carminatives & probiotics and if any will be notified to the IPC and will be uploaded in Vigiflow.(Parental satisfaction on a Likert scale through parental interviews after examining their daily records will be maintained in the dairy)
研究者
Dr. G. Raj Kamal
Chengalpattu medical college and Hospital
研究点 (1)
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