CTRI/2022/04/041949已完成2 期
Double-blind, randomized, placebo-controlled efficacy trial of individualized homoeopathic medicines in fibroadenoma of breast
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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.
研究者
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