MedPath

Homeopathic treatment of breast lumps

Phase 2
Completed
Conditions
Health Condition 1: D249- Benign neoplasm of unspecified breast
Registration Number
CTRI/2022/04/041949
Lead Sponsor
D N De Homoeopathic Medical College Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
63
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

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
ltrasonographic measures of volume of breast lump(s)Timepoint: At baseline, after 3 months and 6 months
Secondary Outcome Measures
NameTimeMethod
Measure yourself medical outcome profile <br/ ><br>version 2 (MYMOP-2) <br/ ><br>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
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