CTRI/2024/08/073058尚未招募2/3 期
Randomized active comparator controlled clinical trial of selected Ayurvedic formulations in pre diabetes and Type 2 Diabetes
Ministry of AYUSH Government of India1 个研究点 分布在 1 个国家目标入组 324 人开始时间: 2024年9月10日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 324
- 试验地点
- 1
- 主要终点
- changes in HbA1c glycated serum protein albumin
研究概览
简要总结
This is a Randomized Active Comparator phase 2 or 3 clinical trial on pre diabetes and type 2 diabetes using ayurvedic polyherbal formulations with Metformin as comparator. Total duration of intervention is 2 years. The sample size is 324 including 3 groups, 108 subjects in each group.
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
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects of either sex Group A type 2 diabetes drug naive HbA1c 7 to 9 percentage Group B Type 2 diabetes on metformin monotherapy HbA1c 7 to 9 percentage Group C prediabetes drug naive HbA1c 5.7 to 6.4 non hypertensive or controlled hypertensive agree for written informed consent.
排除标准
- •type 1 diabetes mellitus diabetic complications, hypertension Hb less than 10 pregnant and lactating women LFT RFT TSH and lipid profile under abnormal limits psychiatric illness.
结局指标
主要结局
changes in HbA1c glycated serum protein albumin
时间窗: Baseline and at 1 3 6 12 18 and 24 months
次要结局
- Change in cystinallated truncated and di or tri oxydised albumin(changes in HOMA 2 IR and HOMA 2 B)
研究者
Dr S Srikanta
Samatvam Science and Research for Human Welfare Trust
研究点 (1)
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