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Evaluation of Firooz fissure cream containing lanolin in improving the pain and severity of fissure lesions

Evaluation of safety and clinical efficacy of Firooz brand name fissure cream containing lanolin in improving the pain and severity of fissure lesions in lactating women

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190210042676N27
Enrollment
20
Registered
2022-10-29
Start date
2022-11-06
Completion date
Unknown
Last updated
2022-11-21

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

Conditions

Fissure of nipple. Fissure and fistula of nipple

Interventions

Intervention group: Using Firooz brand lanolin cream on the nipple and areola at least 5 times a day after each breastfeeding..

Sponsors

Firooz Health Group Company
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Lactating women aged 18 to 45 with term babies (weighing 2500 to 4000 grams) General health Signing the consent form for participation in the study Breast pain from severity 1 to 3

Exclusion criteria

Exclusion criteria: People with puerperal fever A newborn suffering from jaw and mouth abnormalities such as short frenulum or oral infections Mothers suffering from diabetes Use of any local treatment for fissure three days before the study

Design outcomes

Primary

MeasureTime frame
Pain during breastfeeding. Timepoint: Before intervention, 48 hours and 7 days after that. Method of measurement: By a 6-point Likert scale (Not satisfied at all = 0, Very little = 1, Little = 2, Average = 3, Much = 4 and Very much = 5).

Secondary

MeasureTime frame
Severity of fissure of nipple. Timepoint: Before intervention, 48 hours and 7 days after that. Method of measurement: Severity of fissure of nipple 1 to 3 based on: 0) No microscopically visible skin changes, 1) Erythema or edema or combination of both, 2) Superficial damage with or without scab formation on 25% of the nipple surface, 4) Partial-thickness wound with or without scab formation on <25% of the nipple surface, 5) Partial-thickness wound with or without scab formation on <25% of the nipple surface.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAniseh Samadi

Tehran University of Medical Sciences

aniseh_samadi@yahoo.com+98 21 8896 0880

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026