Clinical study to evaluate the safety and efficacy of a Nursing Gel in healthy pregnant females and lactating females with sore & cracked nipples.

Not Applicable

Completed

• Conditions: Health Condition 1: N645- Other signs and symptoms in breast

• Registration Number: CTRI/2022/08/044645
• Lead Sponsor: Zydus Wellness Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-11-30
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1)Sex: Females, either of the following

a.Healthy pregnant females (3rd trimester).

b.Lactating females (post pregnancy mothers having 0 to 3 months old baby).

2)Subjects with mild to moderate nipple soreness/pain based on visual analogue scale (VAS).

3)For Post Pregnancy Mothers: Subjects having history of delivery within 42 weeks.

4)For Pregnant females: Primipara (woman who is giving birth for the first time) subjects, who are diagnosed as pregnant female by gynaecologist.

Exclusion Criteria

1)Subjects having contraindications for breastfeeding

2)Newborn with no oral, palatal or maxillofacial abnormalities.

3)Subjects with history of development of any breast problem: Mastitis, engorgement etc.

4)Subjects not willing to discontinue other nipple crack preventing method during application.

5)Subjects who are not taking any pain management medication e.g., NSAIDâ??s, pain killers, etc.

6)Participation in a similar clinical study within the previous 90 days.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1)Gynecological assessment of nipple soreness/pain using visual analogue scale (VAS). <br/ ><br>2)Dermatological assessment of nipple skin dryness, nipple skin roughness, nipple skin redness/erythema, burning, itching, stinging using 5-point scoring scale.Timepoint: Baseline, Day 02, Day 14

Secondary Outcome Measures

Name	Time	Method
Assessment of skin barrier function using TEWAmeter /Vapometer.Timepoint: Baseline, Day 02, Day 14;Assessment of skin hydration using Corneometer /Moisturemeter SC.Timepoint: Baseline, Day 02, Day 14;Digital Photographs of the nipple and surrounding areaTimepoint: Baseline, Day 02, Day 14;Subject Satisfaction Questionnaire and Product Response Index (Perception about Product).Timepoint: Baseline, Day 02, Day 14