Study on effects of black seed oil in treatment of cyclic mastalgia

Study on effects of topical Nigella sativa seed oil in treatment of cyclic mastalgia.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201506132288N8

Enrollment

150

Registered

2015-06-25

Start date

2014-04-26

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Mastalgia. Mastodynia

Interventions

Intervention 1: Nigella sativa seed oil gel is used at the dose of 600 mg topically on the site of breast pain twice daily in 50 patients for 2 months. Intervention 2: Diclofenac gel is used at the do

Treatment - Drugs

Nigella sativa seed oil gel is used at the dose of 600 mg topically on the site of breast pain twice daily in 50 patients for 2 months

Diclofenac gel is used at the dose of 20 mg topically on the site of breast pain twice daily in 50 patients for 2 months

Placebo gel is used topically on the site of breast pain twice daily in 50 patients for 2 months

Eligibility

Sex/Gender

Female

Age

25 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Iranian outpatient females with cyclic mastalgia, patients aged 25-45 years; patients with regular menstrual cycles; patients with cyclic mastalgia diagnosis based on history of cyclic mastalgia for at least the past 3 consecutive cycles, patients with pain duration of at least 7 days per month and mastalgia severity score greater than 4 on a 10 centimeter visual analogue scale requiring pharmacotherapy. Exclusion criteria: Patients receiving hormone therapy or hormonal contraceptive; patients with irregular menstrual cycles; patients with history of breast and endometrial cancer, hysterectomy and bilateral oophorectomy; pregnanct women; brest-feeding women; women planning pregnancy; women with serious health problems.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Pain severity score. Timepoint: Before, 1 and 2 months after beginning of the intervention. Method of measurement: 10 centimeter visual analog scale.	—

Secondary

Measure	Time frame
Adverse drug reactions. Timepoint: 1 and 2 months after beginning of the intervention. Method of measurement: Patient report.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Saeed Kianbakht

ACECR Institute of Medicinal Plants

skianbakht@yahoo.comskianbakht@gmail.com+98 26 3476 4010

Outcome results

None listed

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