Effectiveness of the Individualized Homoeopathic Medicines in LM potencies as an adjuvant to conventional medicines in the management of Type-2 Diabetes Mellitus: A single-blind randomized controlled clinical trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The changes in HbA1C values.
研究概览
简要总结
This study is a single blind randomized controlled clinical trial to find out the effectiveness of the Individualized Homoeopathic Medicines in LM potencies as an adjuvant to conventional medicines in the management of Type-2 Diabetes Mellitus . The primary outcome is to assess the changes in glycaemic control in the participants withT2DM after the administration of Individualized Homoeopathic Medicines in LM potencies as an adjuvant to conventional medicines compared tothose who are taking conventional medicines with placebo. The secondary outcomes are to measure the changes in the FBS and PPBS levels and changes in the quality of life using the Quality of Life Instrument for Indian Diabetes Patients (QOLID) Questionnaire at the baseline and at the conclusion of the study.The study duration is 1 year 6 months (inclusive of enrollment period of 1 year and a period of 6 months for the follow-up).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Diagnosed cases of Type-2 Diabetes Mellitus taking conventional anti-diabetic medications.
- •2.Participants with HbA1C levels more than 6.5%.
排除标准
- •1.Pregnant women and lactating mothers.
- •2.Cases with known underlying immune deficiencies or serious illness.
结局指标
主要结局
The changes in HbA1C values.
时间窗: Baseline, 6 months (Conclusion of the study).
次要结局
- Changes in the FBS and PPBS levels.(Baseline, 6 months(Conclusion of the study).)
- Changes in the quality of life will be assessed using the Quality of Life Instrument for Indian Diabetes Patients (QOLID) Questionnaire(Baseline, 6 months (Conclusion of the study).)
研究者
Dr Pawan Sharma
National Homoeopathy Research Institute in Mental Health