CTRI/2024/11/077229尚未招募不适用
A randomized open label controlled clinical study; to evaluate the efficacy of vrundatriphaladi ghanvati as adjuvant therapy in prameha with special reference to type 2 diabetes Mellitus.
R A Podar Medical College Ayu1 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2024年11月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Fasting BSL,Post prandial BSL,Hba1c and hs-crp(inflammatory parameter).
研究概览
简要总结
This study is a randomized open label controlled clinical study, to evaluate the efficacy of vrundatriphaladi ghanvati as adjuvant therapy for 12 weeks in 119 patient with prameha (type 2 diabetes mellitus). The primary outcome will be F - BSL , PP-BSL, Hba1c and hs-crp from base line to 12 weeks . secondary outcome will be on symptoms score of prameha at 12 weeks.
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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •patient having classical sign and symptoms of prameha.
- •BSL 126 to 250 mg or BSL PP gretar than 200mg to 300 or Hba1c gretar than 6.5 to 9 percentage or random BSL gretar than 200 mg.
排除标准
- •Acute medical and surgical illness IDMM diabetes ketoacidosis gestational diabetes drug induced diabetes pregnant and lactating women impaired renal function.
结局指标
主要结局
Fasting BSL,Post prandial BSL,Hba1c and hs-crp(inflammatory parameter).
时间窗: 12 weeks
次要结局
- on symptoms score of prameha at 12 weeks(on changes in lipid profile and BMI from baseline to 12 weeks in prameha.)
研究者
Vinayak Pache
Government Ayurvedic College Dharashiviv.
研究点 (1)
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