Post Marketing Observational Study PMOS To Evaluate the Safety and Efficacy of HBTM 102109 Baby Tummy Roll On in 0-36 Months Babies
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 20
- 主要终点
- To evaluate the safety and efficacy of Test Product in study population,Safety and efficacy will be assessed at the end of the study visit.
研究概览
简要总结
**STUDYOBJECTIVE:**To evaluate the safety and efficacy of baby tummy rollon in 0-36 month’s babies with at least any one condition such as colicpain, indigestion, constipation, gas and bloating.
**STUDY DESIGN:**An open label, postmarketing observational study.
StudyMethodology:
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Parents/LegallyAcceptable Representatives (LARs) of the baby will be provided with the Parent consentdocument and explained about the study in detail.
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Babies who fulfil theselection criteria will be enrolled into the study after written parent consent.
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The subject’s parent/LAR will be provided with The Himalaya baby tummy roll on, and they will beinstructed on the use the product by the study doctor/ coordinator.
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Assessments will beperformed on Day 1/baseline and till symptoms resolution or day 3 + 1 daywhichever is earlier (end of the study visit) as per the schedule of events.
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If subjects score forLocal intolerance is scored 1= Mild, 2=Moderate, 3=Severe, then the undesirableeffect page to be completed.
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All undesirableeffects to be followed up till the event is stabilized or 7days whichever isearlier
Studyduration: Thisstudy is planned till symptoms resolution or day 3 (+ 1 day) whichever isearlier.
Numberof Subjects: 500 subjects will be enrolled.
**StudySite:**Thestudy will be conducted at 20 sites.
Directions to Use: Apply directly on baby’s stomach around thenaval area. Gently massage with hand if required. Keep using until baby getsbetter.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 0.00 Day(s) 至 36.00 Month(s)（—）
- 性别
- All
入选标准
- •Subjects in the age group of 0 to 36 months.
- •Subjects with at least any one condition such as colic pain, indigestion, constipation, gas and bloating.
- •Subjects not using similar products during the study period.
- •Subjects who have not participated in similar clinical trial in the past 4 weeks
- •Subjects in general good health as determined from a recent medical history and physical examination.
- •Subject’s mother/legal guardian willing to give a voluntary written parent consent and agree to complete study activities and come for regular follow up with subject.
排除标准
- •1.A known history or present allergic condition that may require medical attention.
- •2.Chronic illness which may influence the cutaneous assessment.
- •3.Subjects not willing to stop the use of other tummy oil or any medication for this indication during study period.
结局指标
主要结局
To evaluate the safety and efficacy of Test Product in study population,Safety and efficacy will be assessed at the end of the study visit.
时间窗: 3 days,
次要结局
- NA(NA)