CTRI/2024/05/067442已完成2/3 期
Evaluation of Comparative Efficacy of Haritaki Vati versus Metformin in Patients of Type 2 Diabetes Mellitus (Madhumeha): A Pilot Study
Ashvini Dinesh Pardhekar1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年5月31日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Relief of symptoms of madhumeha with Fasting and Post meal Blood sugar level became normal
研究概览
简要总结
This study is Randomized single-blind standard control non-inferiority trial comparing the clinical efficacy of Haritaki Vati 1 gm twice a day with honey before meal and Tablet Metformin 250/500 mg twice a day with water before meal for 60 days in 30 patients(15 in each group), the primari outcome will measure by investigationg Fasting and Post Meal blood suger level before and after completion of treatment duration.
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
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects having fasting blood sugar level more than 126 mg/dl and/0r post prandial blood sugar level more than 200mg/dl.
排除标准
- •Fasting Blood sugar level ≥200 mg/dl Post Prandial Blood Sugar Level ≥300 mg/dl Pregnant and lactating women.
- •Patients with acute complications like cirrhosis of liver, Pancreatitis, and Hypoglycemic shock.
- •Patients with chronic complications like Nephropathy, Retinopathy and Neuropathy.
结局指标
主要结局
Relief of symptoms of madhumeha with Fasting and Post meal Blood sugar level became normal
时间窗: Fasting and Post meal Blood sugar level became normal
次要结局
未报告次要终点
研究者
Ashvini Dinesh Pardhekar
Datta Meghe Institute of Higher Education and research Center Deemed to be University Wardha
研究点 (1)
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