Study to Compare Effectiveness of Potencies Within and Beyond Avogadro Limit of Individualised Homoeopathic Medicine among Pre-Diabetic Adults by Assessing Glycemic Control: An Open-Level Randomized Parallel-Arm Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Glycosylated hemoglobin (HbA1C)
研究概览
简要总结
Pre-diabetes is an intermediate state of hyperglycemia characterized by elevated blood glucose concentrations, such as impaired fasting glucose (IFG), impaired glucose tolerance (IGT) and elevated glycated haemoglobin A1c (HbA1c). According to the American Diabetes Association (ADA), Pre-diabetic conditions can be detected by Oral Glucose Tolerance Test ranging between 140 and 199 mg/dL and/or Fasting Blood Sugar ranging between 100 and 125 mg/dL and/or glycated haemoglobin(HbA1c) percentages of 5.7 to 6.4%. It is a major contributor to the global diabetes epidemic and is a growing global health concern today. It Half of pre-diabetic patients has tendency to converted into Type-2 Diabetes Mellitus (T2DM). Avogadro limit is becoming a hot topic to criticise diluted homoeopathic medicine by ignoring its dynamic curing action on real life. This study aims to discard the ongoing surrounding debate about the mechanisms of action in homeopathy by comparing the effectiveness of different potencies within and beyond the Avogadro limit. The results of this trial could shed light on whether potencies beyond the Avogadro limit have any clinically meaningful impact on glycemic control in pre-diabetic adults compared to those within the Avogadro limit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 79.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient age within 20-79years, both male and female.
- •Indian Diabetic Risk Score (IDRS) above/equal to
- •Impaired glucose regulation i.e. fasting plasma glucose concentration value 100-125mg/dL and/or two hrs.
- •post 75gm glucose load plasma glucose value 140-199mg/dL.
- •Patients with written consent to participate in this study.
- •Literate patients.
排除标准
- •Patient suffering from uncontrolled systemic illness, life-threatening infections or any vital organ failure/s
- •Patient already undergoing homoeopathic treatment for any chronic disease
- •Patient with self-reported immune-compromised states
- •Pregnant women/lactating mother
- •Patient without consent to take part or Illiterate patient.
结局指标
主要结局
Glycosylated hemoglobin (HbA1C)
时间窗: Baseline, after 3 months
次要结局
- Fasting blood glucose level(Baseline, after 3 months)
- Blood glucose level after 2 hours of 75 gm glucose load(Baseline, after 3 months)
研究者
Avidipta Hazra
Metropolitan Homoeopathic Medical College and Hospital