Evaluation of the effect of Cephalandra indica in centesimal potencies in reducing HbA1c levels in Type II Diabetes mellitus single arm interventional study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Cephalandra indica causes significant reduction in serum HbA1c levels in patients suffering from Type 2 Diabetes mellitus
研究概览
简要总结
Research Question is Does Cephalandra indica in centesimal potency have any significant effect in reducing HbA1c levels in patients of Type 2 Diabetes mellitus over 6 months of treatment?
Null Hypothesis is There is no significant reduction in HbA1c level in patients of Diabetes mellitus type 2 treated with Cephalandra indica in centesimal potency over 6 months.
Alternate hypothesis is There is significant reduction in HbA1c level in patients of Type 2 Diabetes mellitus treated with Cephalandra indica in centesimal potency over 6 months.
Aim is to determine the usefulness of Cephalandra indica in centesimal potency in patients suffering from Type 2 Diabetes mellitus where the primary objective is to compare the mean score of HbA1c levels over 6 months of treatment.
The secondary objective is to compare the mean score of serum FBS and PPBS level in patients of Type 2 Diabetes mellitus over 6 months of treatment. To compare the mean score of the Quality of life SF36 questionnaire in patients of Type 2 diabetes mellitus over 6 months of treatment and to assess the causal relationship between the given intervention and the clinical outcome through MONARCH at 6th month.
It is a single arm interventional study , conducted at the OPD setting of National Institute of Homoeopathy, Kolkata where each case will be taken in detail, appropriate consent taken and then the patient will be enrolled. Adequate lifestyle and dietary modification will be advised for good results. Appropriate statistical tools will be used and data analysed at the end of the study.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age from 30 to 60 years all genders willing to give written consent for participation and able to understand Bengali/ English/ Hindi HbA1c more than 6.5% less than 8 % Fbs more than 126 mg/dL less than 250 mg/dL Ppbs more than 200 mg/dL less than 350 mg/dL Patients with symptoms of Cephalandra indica.
排除标准
- •Patients aged below 30 and above 60 years Patients having severe complications like hypoglycaemic coma retinopathy malignancy etc Immunocompromised patients suffering from HIV TB or psychiatric illness or under any antihypertensive anti diabetic or steroid medication or taking homeopathic medicine for any other systemic disorder in the last 3 months Patients not willing to give written consent or undergo any investigation as well as pregnant and lactating mothers.
结局指标
主要结局
Cephalandra indica causes significant reduction in serum HbA1c levels in patients suffering from Type 2 Diabetes mellitus
时间窗: Baseline 3 months and 6 months
次要结局
- Cephalandra indica in centesimal potency causes significant changes in serum FBS, PPBS levels in patients of Diabetes mellitus type 2(Cephalandra indica in centesimal potency causes significant changes in the score of quality of life questionnaire SF36)
研究者
Dr Vaishnabi Rastogi
National Institute of Homoeopathy