Comparative study of individualised Homoeopathic medicines with standard line of treatment in management of Lymphedema
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Change in the limb circumference from baseline to end of treatment at 12 weeks measured at standardised anatomical landmarks.
研究概览
简要总结
This study will assess the effectiveness of individualised Homoeopathic medicines and standard treatment protocol consisting of complete decongestive therapy in management of Lymphedema.Adults between 18 to 70 years with primary or secondary Lymphedema will be included in the study.The primary outcome is change in limb circumference in 12 weeks .Secondary-outcomes include quality of life and function of limbs.The study aims to determine the potential role of individualised Homoeopathic medicines as an adjuvant to Lymphedema management .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Confirmed lymphedema (primary or secondary) by medical history, physical examination, and imaging studies.
- •Severity: Mild, moderate, or severe lymphedema (Stage 0-3) Patients presenting with chronic or episodic Lymphedema symptoms such as Swelling, pain, heaviness, or limited mobility in affected limb Ability to provide informed consent and compley with the study.
排除标准
- •Pregnancy or lactation Severe systemic diseases (e.g., heart failure, severe kidney disease, severe liver disease) Limb amputation or severe trauma to affected limb.
结局指标
主要结局
Change in the limb circumference from baseline to end of treatment at 12 weeks measured at standardised anatomical landmarks.
时间窗: Baseline ,4 weeks ,8 weeks and 12 weeks
次要结局
- Quality of life , change in disease specific quality of life(LYMQOL)questionnaire(Change in quality of life from baseline to end of treatment at 12 weeks)
研究者
Nayana Parmar
Dr.D.Y.Patil Homoeopathic Medical College and research centre,Pune