Effects of melatonin supplementation in the treatment of fibrocystic changes of breast

Comparing the effects of probiotic supplementation and placebo on clinical status and metabolic profiles in overweight or obese women with fibrocystic changes of breast

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170513033941N68

Enrollment

Registered

2020-04-05

Start date

2020-03-05

Completion date

Unknown

Last updated

2020-05-18

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: Probiotic capsule (Zisttakhmir Co., Tehran, Iran), including 2×109 Lactobacillus acidophilus, 2×109 Bifidobacterium bifidum, 2×109 Lactobacillus reuteri, 2×109 Lact

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 Unwillingness to cooperate

Design outcomes

Primary

Measure	Time frame
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
Breast Pain Severity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Visual analogue scale 0-10.;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.;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.;Depression score on Beck Depression Inventory. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.;Anxiety score on Beck Anxiety Inventory. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.;Sleep Quality score on Pittsburgh Sleep Quality Index. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.	—

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.;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.;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.;Depression score on Beck Depression Inventory. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.;Anxiety score on Beck Anxiety Inventory. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.;Sleep Quality score on Pittsburgh Sleep Quality Index. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Seyed Hamed Rouhani

Kashan University of Medical Sciences

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

Outcome results

None listed

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