Effectiveness of rubrics related to foot ulcers from Homeopathic Repertories in treatment of Diabetic Foot Ulcers
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- - Comparison of change in size of wound area
研究概览
简要总结
This study aims to evaluate the effectiveness of homoeopathic medicines selected using predefined foot-ulcer-related rubrics from various repertories in the treatment of Diabetic Foot Ulcers (DFU). Forty DFU patients (Wagner grade 1–3, age 18–80) who meet the inclusion criteria and do not present gangrene, osteomyelitis, malignancy, severe systemic diabetic complications, or life-threatening illness will be enrolled. The primary objective is to assess the usefulness of selected rubrics in identifying the simillimum, while secondary objectives include evaluating clinical improvement, wound-healing progress, and changes in characteristic rubrics during treatment. Interventions include detailed case-taking, repertorial analysis using standard repertories, individualized homoeopathic prescription as per Organon guidelines.
Outcomes will be measured using the Bates–Jensen Wound Assessment Tool, and changes in wound size, appearance, symptoms, and overall healing response. The study expects to document clinical efficacy of rubric-based homoeopathic management and identify characteristic ulcer features guiding remedy selection in DFU.
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
- 30.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed Insulin.
- •dependent or non.
- •insulin dependent Diabetes Mellitus.
- •Patients presenting with ulcer on the lower extremity for more than 1 Week.
- •Patients taking Allopathic medications on which they are dependent.
- •During the study the patients area allowed to continue Anti- hypertensive and/ or Statin drugs.
排除标准
- •Cases presenting with gangrene or impending gangrene.
- •Ulcers with underlying osteomyelitis.
- •Venous ulcers or ulcers due to any other cause.
- •Cases diagnosed with Malignancies.
- •Cases presenting with a long term complication of Diabetes.
- •Patients requiring intravenous antibiotics, emergency management or surgical intervention.
- •Patients suffering life.
- •threatening or chronic diseases like IHD of less than 6 months duration, Unstable angina, Hypertension, Malignancy or HIV/AIDS etc.
- •History of Coma.
结局指标
主要结局
- Comparison of change in size of wound area
时间窗: 3 Months
- Complete closure or epithelisation
时间窗: 3 Months
- Decline of clinical symptoms.
时间窗: 3 Months
- Wound healing
时间窗: 3 Months
次要结局
- - Clinical Course of Diabetic Foot Ulcer during Homoeopathic treatment in terms of ulcer characteristics and individual symptoms.(- To identify the additional clinical symptoms (provings) of the Homoeopathic medicines used during the study.)
研究者
Dr Hema Suresh
Sarada Krishna Homoeopathic Medical College