An Open Label, Two Group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of Nipple Care Butter in Prevention and Treatment in the Cracks, Soreness and Dryness of Nipples in Pregnant Women and Post-Partum Women
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- 3) To determine the experience of test product perception and subjective feedback of test product usage on nipples (softens and moisturizes the skin, non-sticky, safe in pregnancy, nipple conditioning before initiating breastfeeding) using questionnaires.
研究概览
简要总结
An open-label, two groups, multicenter clinical study to evaluate safety and efficacy of Nipple Care Butter in prevention/conditioning of nipples in pregnant women and treatment/reduction in the cracks, soreness and dryness of nipples in post-partum women. The potential subjects will be screened as per the inclusion & exclusion criteria only after obtaining written informed consent from the subjects. The subjects will be instructed to visit the facility as per the below visits.
Group-I: The women with 32 week (± 2 weeks) of pregnancy till delivery:
• Screening/Baseline visit (Day 1/Visit 1)
• Follow up telephonic visit (Visit 2/Day 14)
• EOS/Visit 3 at week 38 (± 2 weeks) or date of delivery whichever is earlier.
Group-II: Post-Partum women (post-delivery up to 3 months) with nipple cracks, soreness and dryness of nipples.
• Screening/Baseline visit (Day 1/Visit 1),
• Follow up telephonic visit (Visit 2/Day 3 + 2)
• EOS/Visit 3 until the resolution/reduction of symptoms or maximum of 4 weeks. After the resolution of the symptoms, subjects will have to complete the EOS assessments.
A total of 150 evaluable subjects (50 pregnant women in Group-I & 100 post-partum women in Group-II above >18 years of age)
Group-I: Prevention in the cracks, soreness and dryness of nipple or associated symptoms in pregnant women (N=50)
Group-II: Treatment/reduction in the cracks, soreness and dryness of nipple in post-partum women (N=100)
Nipple Care Butter is lanolin-free, mineral oil free herbal composition with goodness of natural oils ideal for both expecting mothers in preparing the nipple for effective nursing and for lactating mothers in the prevention and management of sore and cracked nipples.
Instructions of Use: Apply Nipple Care Butter to the nipple and areola and massage gently, or as directed by your gynaecologist.
• Group-I: Twice daily for conditioning (prevention aspect in pregnant ladies)
• Group-II: For lactating mothers, we may proceed with directions as apply after each feeding/in between feed, as often as needed with instruction to wipe/clean the nipples before feeding.
Following assessments will be recorded-Investigator Assessment Scale, Symptom Assessment Scale, Visual Analog Scale (VAS), Paediatric Assessment Scale and Subjective Assessment Questionnaire.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •Age: ≥ 18 years at recruitment.
- •Women with the following: ➢ Group-I: Healthy pregnant females (32 ± 2 weeks of pregnancy) ➢ Group-II: Lactating females: post-delivery having baby less than 3 months old.
- •Subjects with mild to moderate nipple cracks, dryness, soreness/ pain based on Visual Analog Score.
- •For post pregnancy mothers delivered baby within 37-42 weeks.
- •Subjects not having nipple abnormalities (e.g., flattening, indenting, bulging, or any apparent nipple deformity).
- •Subject is willing to give written informed consent and is willing to follow the study procedure.
- •The subject is willing to use test product throughout the study period.
排除标准
- •Subjects with high-risk pregnancy.
- •Subjects with severe breast inflammation/Mastitis requiring systemic treatment.
- •History of breast abscess, fungal infections.
- •Known case of dermatological disorders.
- •Mothers with babies unable to take feed directly.
- •Subjects with severe nipple cracks, cuts, bleeding, severe pain.
- •Bad obstetric history.
- •Breast Hypoplasia.
- •Having other breast pathology (Breast infection, carcinoma, mastitis, bloody discharge etc.).
- •Women with skin allergies or taking medications for skin allergies.
- •Subjects not willing to discontinue other nipple crack preventing method during application.
- •Subjects who are taking any pain management medication e.g., NSAID’s, pain killers, etc.
- •Subject in a similar clinical study within the previous 4 weeks.
- •Women who are unable to give informed consent.
结局指标
主要结局
3) To determine the experience of test product perception and subjective feedback of test product usage on nipples (softens and moisturizes the skin, non-sticky, safe in pregnancy, nipple conditioning before initiating breastfeeding) using questionnaires.
时间窗: Day 1, Day 7, Day 42
2) To evaluate the symptoms assessment using 10-point scoring scale by Investigator.
时间窗: Day 1, Day 7, Day 42
1) To assess the mildness, gentleness, moisturization and soothing of the test product on skin by the Investigator.
时间窗: Day 1, Day 7, Day 42
次要结局
- 1) To evaluate the safety of test product in babies by paediatric assessment scale.(2) To determine the experience of test product perception and subjective feedback questionnaire of test product usage on nipples (starts showing relief from 1st use, heals rashes, soothes cracked and sore nipples, reduction in pain, itchiness, dryness, softness and moisturizes the skin, non-sticky, safe for lactating females, breast feeding mother felt eases pain and discomfort, safer for babies too, helps improving breast feeding experience) using questionnaires.)