A prospective open labelled, single arm, non - randomized, single centric, phase II clinical trial to determine the effectiveness of ayavathi chooranam in the management of deepana silethma noi (dyslipidemia)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
This study is a prospective open labelled, single arm, non-randomized, single centric, phase II clinical trial to determine the effectiveness of AYAVATHI CHOORANAM in the management of DEEPANA SILETHMA NOI(DYSLIPIDEMIA). After purifictaion of trial drugs ayavathi chooranam will be prepared and administered for 48 days for 40 patients.The primary outcome will be to determine the clinical efficacy of ayavathi chooranam (internal) in the management of dyslipidemia and to evaluate the changes in LDL anf TG from baseline to 48th day. The secondary outcome will be to collect various aspects of deepana silethma noi in siddha literatures, to evaluate pharmacological analysis of ayavathi chooranam, to study about the prevalence of deepana silethma noi in relation between diet and lifestyle, to evaluate siddha parameters (including envagai thervu, neerkuri, neikuri) changes in deepana silethma noi, to evaluate the change in serum TC,LDL at 48th day, to document the biostatistical 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
- 25.00 Year(s) 至 65.00 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 for the past 1 month 4.Able to adhere to long term treatment 5.Willing and able to follow scheduled visit plan, diet and exercise instructions, lab tests and other procedures 6.Having voluntarily given their informed consent.
排除标准
- •Combined with any cardiac disorders Combined with any liver disorders Renal disorders Pregnancy and lactating women Participated in any clinical trials of other drug in the past 4 weeks.
研究者
Dr G Vandhana Sai
Government Siddha Medical College and Hospital
