A Randomized Placebo-Controlled Trial Evaluating the Effect of Individualized Homeopathic Medicine for Wound Healing.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 108
- 试验地点
- 1
研究概览
简要总结
Wound healing is a complex, dynamic biological process involving the restoration of skin integrity following injury due to trauma, surgery, burns or chronic disease. Successful wound healing requires a coordinated sequence of haemostasis, inflammation, proliferation and remodelling, all of which can be disrupted by local or systemic factors. When the healing process is impaired or delayed, wounds may become chronic, leading to increased morbidity, risk of infection and reduced quality of life.This Double blind randomized placebo-controlled trial conducted at The Calcutta Homoeopathic Medical College and Hospital,kolkata aimed at providing evidence-based validation of Homoeopathy’s role as a supportive, integrative strategy in managing wounds particularly in cases where conventional therapy alone is insufficient or not well tolerated by enrolling 108 patients in 2:1 randomized ratio (Verum: Control). Primary outcome Measure will be Wound size (cm²) measurement done by using a ruler or transparent graph paper (Simple Planimetry) and Secondary Outcome measures will be Visual Analogue Scale (VAS) for pain measurement (0-10) and Healing Grading Scale (0–3) for Baseline, Week 2 and Week 4 for each patient for a total time period of 6 months.With proper ethical oversight and scientific rigor, the findings could advance integrative and personalized healthcare paradigms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Simple, clean wounds (traumatic or surgical) 2) Less than or equal to 5 cm in diameter 3) Wound onset within the last 72 hours 4) Consent to participate.
排除标准
- •Infected or chronic wounds like diabetic, pressure ulcers.
- •Immunocompromised conditions like HIV, chemotherapy.
- •Use of antibiotics or other healing agents on the wound.
- •Allergy to alcohol-based preparations.
研究者
RITWICK SAHA
The Calcutta Homoeopathic Medical College and Hospital
