An Open label, Clinical Study to Evaluate the Safety and efficacy of HSBP-121901 in babies of 0 – 36 months of age
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1. Mildness gentleness and irritation as assessed by
研究概览
简要总结
This is an Open-Label, Clinical Study to Evaluate the Safety and efficacy of HSBP-121901 in babies if 0 – 36 months of age.
As the newborn skin easily become dry and the skin very vulnerable to infections. HSBP- 121901 have many advantages like being hygienic for the infant’s skin, reducing rashes and irritations and also preventing infections caused by diapers. This study evaluates the benefits of baby diaper pants in terms of mildness, gentleness and non-irritability on baby’s skin and also the prevention of diaper rashes, less frequent change of diapers, Withstand multiple wettings, overnight use, Undisturbed, restful sleep for the baby; Less crying, less cranky after waking up, Provides soft and tender care with less friction of the diaper, No incidence of leakage of urine or faeces, Ease of diaper application and removal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 0.00 Day(s) 至 36.00 Month(s)（—）
- 性别
- All
入选标准
- •Babies in the age group of 0 to 36 months (inclusive of both genders)
- •Babies in general good health as determined from recent medical history and the Pediatrician.
- •Baby’s mother/legal representative, preferably mother willing to give a voluntary written informed consent and agree to come for regular follow up.
- •Baby’s mother/legal representative, preferably mother willing to abide by and comply with the study protocol.
- •5.Babies should not participate in any other clinical study during participation in the current study.
- •Babies delivered after complete gestation (> 38 weeks).
排除标准
- •Babies with a known history or present condition of allergic response to any other Diapers, toiletries or its components or ingredients as in the test product.
- •Babies with diarrhea/ bowel incontinence
- •Babies with diaper rashes or any allergies in the diaper area.
- •Any pre-existing systemic disease necessitating long term medications and other dermatological problems.
- •Babies requiring incubators/ ventilators or C-PAP.
- •Babies who have participated in a similar clinical investigation in the past four weeks.
结局指标
主要结局
1. Mildness gentleness and irritation as assessed by
时间窗: Day 1 (Baseline) and Day 8
pediatrician assessment Scoring
时间窗: Day 1 (Baseline) and Day 8
2. subjective questionnaire for - helps to prevent diaper rash
时间窗: Day 1 (Baseline) and Day 8
less frequent change of diapers Withstand
时间窗: Day 1 (Baseline) and Day 8
multiple wetting
时间窗: Day 1 (Baseline) and Day 8
overnight use Undisturbed restful
时间窗: Day 1 (Baseline) and Day 8
sleep for the baby
时间窗: Day 1 (Baseline) and Day 8
Less crying
时间窗: Day 1 (Baseline) and Day 8
less cranky after
时间窗: Day 1 (Baseline) and Day 8
waking up
时间窗: Day 1 (Baseline) and Day 8
Provides soft and tender care with less
时间窗: Day 1 (Baseline) and Day 8
friction of the diaper
时间窗: Day 1 (Baseline) and Day 8
No incidence of leakage of
时间窗: Day 1 (Baseline) and Day 8
urine or feces
时间窗: Day 1 (Baseline) and Day 8
Ease of diaper application and removal
时间窗: Day 1 (Baseline) and Day 8
overall satisfaction of the product
时间窗: Day 1 (Baseline) and Day 8
次要结局
- 1. Local intolerance of the product assessed by(Pediatrician)