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Homeopathic treatment of breast lumps

Double-blind, randomized, placebo-controlled efficacy trial of individualized homoeopathic medicines in fibroadenoma of breast

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/041949
Enrollment
68
Registered
2022-04-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Health Condition 1: D249- Benign neoplasm of unspecified breast

Interventions

Sponsors

D N De Homoeopathic Medical College Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a)Patients suffering from fibroadenoma breast (ICD-10 code D24.9) since last 3 months or more. b)Diagnosis of fibroadenoma of breast based on clinical examination, ultrasound image and FNAC. c)Fibroadenoma size between 1 cm and 5 cm at its largest dimension (measured by ultrasonography). d)The tumours may be single, multiple and/or bilateral. e)Female patients of reproductive age group of 18 – 45 years. f)Literate patients: ability to read English, Hindi and/or Bengali. g)Providing written informed consent.

Exclusion criteria

Exclusion criteria: a)Pregnant and puerperal women, lactating mothers b)Phyllodes tumour, atypical tumour c)Complex fibroadenoma and giant (juvenile) fibroadenoma of the breast d)Fibrocystic diseases of the breast e)Tubular adenoma of the breast f)Hamartoma of the breast g)Family history of breast carcinoma among 1st degree relatives h)Patients who are too sick for consultation i)Vulnerable population - unconscious, differently abled, terminally or critically ill patients, mentally incompetent people j)Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure. k)Pregnant and puerperal women, lactating mothers. l)Substance abuse and/or dependence. m)Self-reported immune-compromised state. n)Already undergoing homeopathic treatment for chronic disease within last 6 months.

Design outcomes

Primary

MeasureTime frame
Ultrasonographic measures of volume of breast lump(s)Timepoint: At baseline, after 3 months and 6 months

Secondary

MeasureTime frame
Measure yourself medical outcome profile version 2 (MYMOP-2) Timepoint: At baseline, every month upto 6 months;Number of lesions as detected by ultrasonographyTimepoint: At baseline, after 3 months and 6 months;Short Health Anxiety Inventory-18 (SHAI 18) questionnaireTimepoint: At baseline, after 3 months and 6 months

Countries

India

Contacts

Public ContactProf Dr Sangita Saha

D. N. De Homoeopathic Medical College and Hospital

dr.sangita78@gmail.com9433849505

Outcome results

None listed

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