A study to compare the effect of Vitamin B6 and Vitamin E together versus only Vitamin E in treating non-cyclical breast pain in women of reproductive age.

Efficacy of Vitamin B6 and Vitamin E vs Vitamin E on Non-Cyclical Mastalgia in Women of Reproductive Age Group - A Randomised Control Study - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/086788

Enrollment

Registered

2025-05-13

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Group A - Non cyclical mastalgia : Vitamin B6(40 mcg) + Vitamin E (400 mg ) for 20 days. Control Intervention1: Group B- Non cyclical mastalgia: Vitamin E 400 mg alone for 20 days.

Eligibility

Inclusion criteria

Inclusion criteria: All women aged ranging from 18 to 40 years who present to the surgery outpatient department (OPD) with mastalgia without a discrete lump.

Exclusion criteria

Exclusion criteria: 1. Patients having a history of breast carcinoma or a family history of breast carcinoma 2. Patients in the first 6 months of lactation or patients on OCPS. 3. Patients with irregular menstruation or PCOS. 4. Discrete or dominant lump suspicious of cancer 5. Patients having extra-mammary causes of breast pain. 6. Any history of trauma to the breast.

Design outcomes

Primary

Measure	Time frame
1. Reduction in pain. 2. Reduction in Tenderness.Timepoint: Baseline and day 20 and day 40, and day 60	—

Secondary

Measure	Time frame
Reduction in NodularityTimepoint: Baseline and day 20 and day 40 day 60	—

Countries

India

Contacts

Public ContactDr Subrat Kumar Sahu

Kalinga Institute of Medical Sciences, Bhubaneswar

subrat.sahu@kims.ac.in9238545100

Outcome results

None listed

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