Health Condition 1: P929- Feeding problem of newborn, unspecified
Conditions
Interventions
None listed
Sponsors
Himalaya Wellness Company
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: >= 18 years at recruitment. 2) 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. 3) Subjects with mild to moderate nipple cracks, dryness, soreness/ pain based on Visual Analog Score. 4) For post pregnancy mothers delivered baby within 37-42 weeks. 5) Subjects not having nipple abnormalities (e.g., flattening, indenting, bulging, or any apparent nipple deformity). 6) Subject is willing to give written informed consent and is willing to follow the study procedure. 7) The subject is willing to use test product throughout the study period.
Exclusion criteria
Exclusion criteria: 1) Subjects with high-risk pregnancy. 2) Subjects with severe breast inflammation/Mastitis requiring systemic treatment. 3) History of breast abscess, fungal infections. 4) Known case of dermatological disorders. 5) Subjects delivered abnormal baby. 6) Mothers with babies unable to take feed directly. 7) Subjects with severe nipple cracks, cuts, bleeding, severe pain. 8) Bad obstetric history. 9) Breast Hypoplasia. 10) Having other breast pathology (Breast infection, carcinoma, mastitis, bloody discharge etc.). 11) Women with skin allergies or taking medications for skin allergies. 12) Subjects not willing to discontinue other nipple crack preventing method during application. 13) Subjects who are taking any pain management medication e.g., NSAIDâ??s, pain killers, etc. 14) Subject in a similar clinical study within the previous 4 weeks. 15) Women who are unable to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) To assess the mildness, gentleness, moisturization and soothing of the test product on skin by the Investigator. 2) To evaluate the symptoms assessment using 10-point scoring scale by Investigator. 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.Timepoint: Day 1, Day 7, Day 42 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. 3) To evaluate the product safety by occurrence AEs and SAEs.Timepoint: Day 1, Day 7, Day 42 | — |
Countries
India
Contacts
Public ContactMr Hasan Ali Ahmed
Himalaya Wellness Company
Outcome results
None listed