Evaluating the potential mechanism and efficacy of shodhana-rasayana in comparison with Diabetic Specific Diet and Lifestyle modifications in the management of Madhumeha (Diabetes Mellitus Type 2)on fecal metagenomics - An in-silico and randomized comparative clinical study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Changes in Blood sugar fasting and post prandial and HbA1C
研究概览
简要总结
Present studyis aiming to evaluate the efficacy of Virechana followed by Shilajatu rasayanain patients of Diabetes Mellitus type 2, on various parameters like Blood sugarfasting and post prandial and HbA1C, Apolipoprotein A1, Adiponectin, hs-CRP andAyurveda parameters like Deha bala, agni bala, chetas bala. Study is alsoaiming to see the gut microbiome alterations post Shodhana rasayana therapy in patients of Diabetes Mellitustype 2, which is a first ever attempt to study the same. Study also includesin-silico pathway analysis and ADR prediction of of present Rasayana drug
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed with Diabetes Mellitus according to WHO criteria Subjects diagnosed for Madhemha based on general diagnostic criteria according to document of Protocol for Prevention and Control of Diabetes through Ayurveda, MoA, Page no 37, 2016 Recently diagnosed (0-5 years) patients who are not on OHA (both overweight/obese and normal BMI – ICMR Asian criteria #) Subjects of either gender aged more than 18 years, <60 yrs.
- •Willingness to consent to randomization.
排除标准
- •Emergency cases of diabetes or under immediate consideration for hospitalization and Type 1 DM or Insulin-dependent Patient with inflammatory bowel disease Crohns disease or ulcerative colitis, chronic diarrhoea or malabsorption Hepatitis etc Patient with a history of other complications with DM Female patient who is pregnant, or breast feeding or is considering becoming pregnant during the study or for 6 months after the last dose of study medication Patients having known hypersensitivity to any of the proposed trial drug Currently under any other trial.
结局指标
主要结局
Changes in Blood sugar fasting and post prandial and HbA1C
时间窗: Changes in Blood sugar fasting and post prandial and HbA1C -0,30, 60, 90th days | Changes seen Deha bala agni bala chetas bala- 0, 90th days | Alterations seen in biomarkers such as, Apolipoprotein A1, Adiponectin, hs-CRP-0th and 90th days | Potential pathways and mechanism of Shilajatu along with ADR
Changes seen Deha bala agni bala chetas bala
时间窗: Changes in Blood sugar fasting and post prandial and HbA1C -0,30, 60, 90th days | Changes seen Deha bala agni bala chetas bala- 0, 90th days | Alterations seen in biomarkers such as, Apolipoprotein A1, Adiponectin, hs-CRP-0th and 90th days | Potential pathways and mechanism of Shilajatu along with ADR
Alterations seen in biomarkers such as, Apolipoprotein A1, Adiponectin, hs-CRP
时间窗: Changes in Blood sugar fasting and post prandial and HbA1C -0,30, 60, 90th days | Changes seen Deha bala agni bala chetas bala- 0, 90th days | Alterations seen in biomarkers such as, Apolipoprotein A1, Adiponectin, hs-CRP-0th and 90th days | Potential pathways and mechanism of Shilajatu along with ADR
Potential pathways and mechanism of Shilajatu along with ADR
时间窗: Changes in Blood sugar fasting and post prandial and HbA1C -0,30, 60, 90th days | Changes seen Deha bala agni bala chetas bala- 0, 90th days | Alterations seen in biomarkers such as, Apolipoprotein A1, Adiponectin, hs-CRP-0th and 90th days | Potential pathways and mechanism of Shilajatu along with ADR
次要结局
- Changes seen in Quality of Life in DM(Variations seen in LDL, HDL, TC, HDL/TG Ratio, VLDL and TG)