A CLINICAL TRIAL COMPARING 2 NUTRITIVE SUPPLEMENTS IN THE TREATMENT OF MASTALGIA (PAIN IN THE BREAST)

A RANDOMISED PLACEBO CONTROLLED TRIAL COMPARING 2 NUTRITIVE SUPPLEMENTS IN THE TREATMENT OF MASTALGIA

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/06/005857

Enrollment

Registered

2015-06-03

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Patients with mastalgia

Interventions

Intervention1: EDGE-P PLUS Capsule -1000 mg once daily for 90 days : Each soft gelatin capsule contains- 1)Evening Primrose Oil-1000 mg 2)Mehylcobalamin-750 mcg 3)Excipients-Mixed Tocopherol Intervent

Eligibility

Inclusion criteria

Inclusion criteria: 1) Female patients above 18 years of age 2) Patients complaining of cyclical or noncyclical mastalgia

Exclusion criteria

Exclusion criteria: 1)Patients with carcinoma of the breast 2)Patients with history of seizures 3) Patients on anticonvulsants, phenothiazines or lithium 4)Patients with breast abscess, mastitis or nipple discharge 5)Lactating and pregnant patients 6)Patients on estrogen therapy, digoxin, anticoagulants 7)Patients with breast trauma or after breast surgery

Design outcomes

Primary

Measure	Time frame
Reduction in breast painTimepoint: 3 months and 6 months	—

Secondary

Measure	Time frame
Not applicableTimepoint: Not applicable	—

Countries

India

Contacts

Public ContactDr Badareesh L

Kasturba Medical College, Manipal

stan_mathew@rediffmail.com08202923117

Outcome results

None listed

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