FindTrial
Sign In

Comparison of effectiveness and side effects of standard dose Tamoxifen given alone in comparison to Reduced dose Tamoxifen(Hormonal drug) given in combination with Diclofenac(Anti inflammatory agent) gel applied topically(on skin surface) in patients with severe masnalgia(Breast pain)

Comparison of standard dose standalone Tamoxifen and Reduced dose Tamoxifen in combination with Topical Diclofenac in Severe Mastalgia- A Triple blinded Randomised control Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/01/079612
Enrollment
72
Registered
2025-01-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: N644- Mastodynia

Interventions

Intervention1: Reduced Dose Tamoxifen: The patients will be given Tamoxifen 5mg in OD dosing along with Topical Diclofenac gel for a duration of 3 months Control Intervention1: Standard dose Tamoxifen

Sponsors

All India Institute of Medical Sciences Bhubaneswar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All the females above 18 years presenting to the SOPD with cyclical or noncyclical mastalgia will be assessed for inclusion into the study. All patients with clinically or radiologically detected lump will be evaluated further by histopathological examination. Included patients will be evaluated radiologically by mammogram or ultrasound as indicated to exclude any associated pathology like malignancy/breast abscess/galactocele. The pain will be further evaluated for the need of pharmacological intervention. Only the patients with VAS score more than 5 will be included in the study. Rest will be managed with reassurance.

Exclusion criteria

Exclusion criteria: 1. Age less than 18 year. 2. History of Allergy to diclofenac. 3. Known case of asthma, peptic ulcer disease, hepatic or renal dysfunction. 4. Any evidence of breast malignancy/ discrete breast lump. 5. Pregnant women or Patient Planning pregnancy in the next 6 months 6. Patients with AUB 7. Patients who underwent any other hormonal therapy for severe mastalgia in the past 3 months

Design outcomes

Primary

MeasureTime frame
Pain response as measured by Cardiff breast pain score after 3 months of treatment.Timepoint: 3 months—

Secondary

MeasureTime frame
1. Response to treatment at the end of 30 days 2. Side effects leading to discontinuation of drug. 3. Pain response as measured by Cardiff breast pain at the end of six month. 4. Patient comfort level by using “COMFORT DAISIES ? and preference of drug. Timepoint: 6 months—

Countries

India

Contacts

Public ContactPradeep Kumar Singh

AIIMS Bhubaneswar

avinashvarma.ds@gmail.com8186888889

Outcome results

None listed

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