Effects of melatonin supplementation in the treatment of fibrocystic breast disease

Effects of melatonin supplementation on clinical status and metabolic profiles in overweight or obese women with fibrocystic breast disease

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170513033941N59

Enrollment

Registered

2019-05-27

Start date

2019-05-22

Completion date

Unknown

Last updated

2019-08-26

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

Conditions

breast fibrocystic disease. Benign mammary dysplasia

Interventions

Intervention 1: Intervention group: 10 mg/day melatonin supplement (Zahravi, Tabriz, Iran), one hour before bedtime for 12 weeks. Intervention 2: Control group: Placebo (Barij Essence, Kashan, Iran),

Eligibility

Sex/Gender

Female

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Patients aged 18-45 years women diagnosed with fibrocystic breast disease having moderate or severe cyclic mastalgia BMI = 25

Exclusion criteria

Exclusion criteria: Malignant breast diseases Taking medicines for reducing pain (such as danazol, tamoxifen, bromocriptine) over the past three months Menopause women Pregnant or breastfeeding women Psychological diseases The consumption of any herbal or chemical sedative or hormonal medicines during the study Unwillingness to cooperate

Design outcomes

Primary

Measure	Time frame
Breast Pain Severity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Visual analogue scale 0-10.;High-sensitivity C-reactive protein (hs-CRP). Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.	—

Secondary

Measure	Time frame
Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Beck Depression Inventory. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.;Beck Anxiety Inventory. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.;Pittsburgh Sleep Quality Index. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.;Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA formula.	—

Measure

Time frame

Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Beck Depression Inventory. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.;Beck Anxiety Inventory. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.;Pittsburgh Sleep Quality Index. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.;Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA formula.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Hossein Sadeghi

Kashan University of Medical Sciences

sadeghi.h@gmail.com+98 31 4446 0180

Outcome results

None listed

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