CTRI/2025/07/090572尚未招募3 期
Effectiveness of Advanced Supercritical Fluid Extraction based herbal drug (DiaB Max TM) as an adjunctive therapy in the management of Type 2 Diabetic Patients: A Randomized Controlled, Double-Blind Clinical Trial.
Purple life sciences Pvt Ltd1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年7月20日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- DiaB Max a SCFE-based novel herbal formulation may provide improvement in insulin sensitivity.
研究概览
简要总结
Patients will be randomized based on random allocation software into two groups. Group 1 patient will be given with DiaB Max for 3 months once daily, after food and group 2 given with placebo for 3 months.
Patients will be evaluated with fasting insulin, fasting and post prandial blood sugar and glycated haemoglobin on baseline and end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Type 2 Diabetes Mellitus patients above 18 years of age.
- •Patients receiving antihyperglycemic medication before randomization and HbA1c between 6.5% to 10% at randomization.
- •Patients willing to give informed consent.
排除标准
- •Type 1 Diabetes or uncontrolled T2DM with HbA1c more than 10 %.
- •Pregnant or lactating women.
- •Patients with history of severe liver or kidney disease.
结局指标
主要结局
DiaB Max a SCFE-based novel herbal formulation may provide improvement in insulin sensitivity.
时间窗: DiaB Max a SCFE-based novel herbal formulation may provide improvement in insulin sensitivity.
次要结局
- DiaB Max a SCFE-based novel herbal formulation may result in reduction of HbA1c, FBS, PPBS levels(90 days)
研究者
Dr S N Meenakshi Sundari
SRM Institute of Science and Technology
研究点 (1)
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