Post Marketing Observational Study PMOS To Evaluate the Safety and Efficacy of HBCR – 011805 Soothing Baby Rub In 0-36 Months Babies.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 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
研究概览
简要总结
**STUDYOBJECTIVE:**To evaluate the safety and efficacy of soothing babyrub in 0-36 month’s babies with acute cold symptoms.
**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 Soothing Baby Rub , 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 at the end of the study visit at symptomsresolution or day 7 whichever is earlier 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 7 (+ 1 day) whichever isearlier.
Numberof Subjects: 500 subjects will be enrolled.
**StudySite:**Thestudy will be conducted at 20 sites.
Directions to Use: Take a small amount of Himalaya Soothing BabyRub onto your fingertips and gently apply on your baby’s chest, neck, and back.Use as and whenever required
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
- •1.Subjects in the age group of 0 to 36 months.
- •2.Subject with acute cold symptoms having signs and symptoms as listed below a.Nasal congestion/blockage, b.Itchy nose, c.Sneezing, d.Runny nose.
- •3.Subjects in general good health as determined from a recent medical history and physical examination.
- •4.Subjects mother/legal representative willing to give a voluntary written parent consent and agree to comply with the study protocol.
排除标准
- •1.Subjects with a known history or present condition of allergic response to any other vapo rub, balm, or its components or ingredients as in the test product.
- •2.Subjects having history or present condition of respiratory diseases, or any significant allergies.
- •3.Subjects requiring medical treatment for the indicated symptoms.
- •4.Chronic illness which may influence the cutaneous assessment.
- •5.Subjects who have participated in a similar clinical investigation in the past four weeks.
结局指标
主要结局
To evaluate the safety and efficacy of Test Product in study population
时间窗: 7 days.
次要结局
- NA(NA)