Effectiveness of individualised homoeopathic medicines in managing HbA1C levels in patients suffering from Type2 Diabetes Mellitus using Synthesis Repertory by Frederik Schroyens: An open label prospective clinical study.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- HbA1c levels of each individual patient will be recorded at the time of inclusion into the study (baseline) and after 6 months of treatment, then both the data will be compared.
研究概览
简要总结
Type 2 Diabetes Mellitus is a complex heterogenous metabolic disorder characterised by chronic elevation of plasma glucose levels. The most important pathophysiologic features are decreased insulin sensitivity (insulin resistance) and impaired insulin secretion. It is a major public health issue and an important contributor to morbidity and mortality, not only in India but all around the world. It is most common in people over 30s but is also seen increasingly in adolescents and young adults due to rising levels of obesity, physical inactivity and energy-dense diets. Characteristic laboratory finding is HbA1C levels which is diagnostic also. Type2 Diabetes Mellitus can be successfully managed using homoeopathic medicines, by bringing changes in HbA1C levels to normal range. An open label, prospective clinical study to know the effectiveness of individualised homoeopathic medicines in managing HbA1C levels in people suffering from Type 2 Diabetes Mellitus will take place at National Institute of Homoeopathy, Salt Lake, Kolkata, West Bengal. Study has a target to achieve sample of 40 patients. Outcome assessment will be done by seeing changes in HbA1C levels at baseline and after 6 months. The results will be analysed as per appropriate statistical methods and inference will be done thereafter.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed with Type2 Diabetes Mellitus and not taking any allopathic or other conventional treatment will be considered for the study.
- •Those who are taking hypoglycemic medication will be requested to discontinue the course for a period not exceeding 7days at whatsoever time and those agreeing to it will be considered for this study.
- •Patients whose HbA1c level is above 6.5mg/dl.
- •Adults of both gender and belonging to age group 18yrs-65yrs.
- •Subjects of all socio-economic status and all religions.
- •Patients giving written consent to participate in the study and agree to comply with protocol.
- •Illiterate patients will also be included after providing verbal explanation in vernacular language about the study and getting verbal response and written consent if they agree to participate in study.
- •Subjects who agree to undergo laboratory investigation whenever required.
排除标准
- •Patients with insulin dependence or on any drug dependence for any chronic illness which cannot be discontinued.
- •Patients of unstable mental or psychiatric illness or suffering from any other life-threatening illness/organ failure and immune- compromised state etc.
- •Patients who are pregnant or lactating mothers.
- •Patients not willing to participate in the study.
- •Substance abuse and/or dependence.
- •Cases already undergoing homoeopathic treatment elsewhere for any chronic illness.
结局指标
主要结局
HbA1c levels of each individual patient will be recorded at the time of inclusion into the study (baseline) and after 6 months of treatment, then both the data will be compared.
时间窗: HbA1c levels of each individual patient will be recorded at the time of inclusion into the study (baseline) and after 6 months of treatment, then both the data will be compared.
次要结局
未报告次要终点
研究者
SHANA ANSARI
NATIONAL INSTITUTE OF HOMOEOPATHY