Effectiveness of Individualized Homoeopathic Medicine in the treatment of Fibrocystic Breast Disease : an open label prospective observational study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- in the scoring of The Lucknow Cardiff breast nodularity scale
研究概览
简要总结
This is anon-randomized, open label, single arm, prospective, observational clinicaltrial to show the effectiveness of Individualized Homoeopathic Medicine in thetreatment of fibrocystic breast disease. Patients will be enrolled by followingthe inclusion and exclusion criteria. Diagnosis will be made by Ultrasonographyof both breasts. After proper case taking according to the guidelines given byMaster Hahnemann, Individualized Homoeopathic Medicine will be prescribed toeach and every patient after repertorization and consult with materia medica. Theoutcome of this study will be measured by the changes that occur in thescoring of The Lucknow Cardiff breast nodularity scale and Daily Breast PainCharting. Lucknow Cardiff breast nodularity scale will be measured at baselineand 6th month and Daily Breast Pain Charting will be done at 1stand 6th month. At the end of the study the result will be analysedwith proper statistical technique to show whether the changes made byIndividualized Homoeopathic medicine are significant or not. The level of significancewill be fixed at p less than 0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Patients suffering from FBD for atleast 6 months.
- •2.Women within the age group of 20-50 years.
- •3.Patients who have discontinued other medication for FBD for atleast 3 months prior to the treatment.
排除标准
- •1.Infection or inflammation of the breast including cysts, tumours or galactocele.
- •2.Any congenital abnormality of breast.
- •3.Extra-mammary pain related to any other disorders of the chest.
- •4.Patients suffering from malignant condition of the breast.
- •5.Pregnant and lactating women.
- •6.Patients under treatment of OCP, hormone replacement therapy.
- •7.Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life threatening illness.
- •8.Substance abuse and/or dependence.
结局指标
主要结局
in the scoring of The Lucknow Cardiff breast nodularity scale
时间窗: Baseline & 6 month
The assessment of the outcome of the treatment will be done by the changes that occur
时间窗: Baseline & 6 month
次要结局
- Daily Breast Pain(Charting)