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

An open-label, single-arm study to evaluate the efficacy and safety of a Nursing Gel in healthy pregnant female (3rd trimester) and lactating female (post pregnancy mother having 0 month to 3 months old baby) subjects with sore & cracked nipples.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/08/044645
Enrollment
60
Registered
2022-08-04
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Nursing Gel: Approximately 0.5 gm of test product to be applied on nipples and surrounding area. For lactating mothers, product will be used after every feed for a period of 14 days an

Sponsors

Zydus Wellness Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
1)Gynecological assessment of nipple soreness/pain using visual analogue scale (VAS). 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

MeasureTime frame
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—

Countries

India

Contacts

Public ContactDr Simran Sethi

Cliantha Research

pjoshi@ofacto.com8000085049

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 31, 2026