A prospective open labelled,single arm,non-randomized,single centric, phase II,clinical trial to determine the effectiveness of veppampoo maathirai in the management of deepana silethma noi (dyslipidemia)
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Government Siddha Medical College and Hospital
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To determine the clinical effectiveness of Veppampoo Maathirai (internal) in the management of Deepana silethma noi(Dyslipidemia) and to evaluate the change in LDL from baseline to week 12
概览
简要总结
This is a A prospective open labelled, single arm,non randomized, single centric,phase II,clinical trial to determine the effectiveness of Veppampoo Maathirai in the management of Deepana silethma noi (Dyslipidemia). After purification of trial drugs, Veppampoo maathirai will be prepared and administered for 3 months for 40 Deepana silethma noi patients ( 20 OP and 20 IP Patients). The primary outcome will be to determine the clinical effectiveness of Veppampoo Maathirai (Internal) in the management of Deepana silethma noi (Dyslipidemia) and to evaluate the change in LDL from baseline to week 12. The secondary outcome will be to collect various aspects of Deepana silethma noi in Siddha literatures, to evaluate physico chemical,phyto chemical and bio chemical characters of Veppampoo maathirai, to evaluate safety profile for assessing acute and sub-acute toxicity of trial drug Veppampoo maathirai, to evaluate pharmacological analysis of Veppampoo maathirai, to study about the prevalence of Deepana silethma noi in relation between diet and life style, to evaluate siddha parameters (including Envagai thervu) changes and dhegi in Deepana silethma noi during the study period, to evaluate modern parametric changes in Deepana silethma noi, to document the Bio statistical analysis, to assess the Quality of life of Deepana silethma noi patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Diagnosis of primary dyslipidemia 2.TC above 200 mg /dl,LDL above 130mg/dl,VLDL above 30mg/dl,TG above 200mg/dl 3.Having not taking any Lipid Lowering Drugs within the past 1 month 4.Able to adhere to long term treatment 5.Willing and able to follow the scheduled visit plan, diet and exercise instructions, laboratory tests,and other procedures 6.Having voluntarily given their informed consent.
排除标准
- •1.History of CAD/ CVA within the past 4 weeks 2.Combined with nephrotic syndrome, or renal insufficiency 3.Combined with poorly controlled hypothyroidism or other endocrine disease 4.Combined with severe or active liver diseases 5.Combined with severe or any other life threatening disease 6.Allergy to component of the product or allergic constitution 7.Combined with mental disorders 8.Participated in clinical trials of other drugs in the past 4 weeks.
结局指标
主要结局
To determine the clinical effectiveness of Veppampoo Maathirai (internal) in the management of Deepana silethma noi(Dyslipidemia) and to evaluate the change in LDL from baseline to week 12
时间窗: 3 months
次要结局
- 1.To collect various aspects of Deepana silethma noi in Siddha literatures.(2.To evaluate physico chemical,phyto chemical and bio chemical characters of Veppampoo maathirai.)
研究者
PRAKATHI R
Government Siddha Medical College and hospital, Palayamkottai