A Clinical Interventional Study To Find Out The Effectiveness Of Individualized Homoeopathic Medicine In Resolution Of Adenomyosis
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Outcome measurement can be done by ultrasonographic (Abdomen and Pelvis) findings at baseline and at 6 month and by the end of the study following administration of Individualized Homoeopathic medicine.
研究概览
简要总结
This study is an open label, single arm,clinical interventional study to determine the Effectiveness of Individualized Homoeopathic Medicine in Resolution of Adenomyosis , that will be conducted in OPD, IPD and Peripheral units of Department of Practice of Medicine at National Homoeopathy Research Institute in Mental Health , Kottayam . The primary outcome is measured by assessing the ultrasonographic (Abdomen and pelvis ) at baseline , 6th month and end of study . The secondary outcome is measured by assessing the severity of dysmenorrhea of adenomyosis using WaLLID score and reduction in heavy bleeding of adenomyosis using Heavy menstrual bleeding questionnaire at baseline, 3rd month, 6th month, 9th month , and at end of study. As the atudy with the aforementioned domains is one of its kind , it aims to make the efforts to other possibilities for future research in the effectiveness of Individualized Homoeopathic Medicine in Resolution of Adenomyosis .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Age group :
- •Patients with positive Ultrasonography findings for Adenomyosis.
排除标准
- •Cases with active malignancy.
- •Patients with known serious systemic illness
- •Haemoglobin level less than 7g / dl .
- •Uterine fibroid with size greater than 7cm
- •Patients under regular conventional treatment for dysmenorrhea.
- •Pregnant & Lactating women.
结局指标
主要结局
Outcome measurement can be done by ultrasonographic (Abdomen and Pelvis) findings at baseline and at 6 month and by the end of the study following administration of Individualized Homoeopathic medicine.
时间窗: At baseline , 6th month and 12th month
次要结局
- Reduction in symptoms are assessed based on the WaLLID score & Menstrual Bleeding Questionnaire.(At baseline, 3rd month, 6th month, 9th month & 12th month)
研究者
Dr Reshma Ramanan
National Homoeopathy Research Institute in Mental Health