A Prospective Open Labelled non randomized phase II Clinical study On Oorithalthaamarai Chooranam in the management of Madhumegha noi muthalavathu avasthai – parutha udal (Diabetic Dyslipidemia)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- During treatment or after treatment,
研究概览
简要总结
The study is a prospective open labelled phase II non-randomized clinical study to evaluate the
therapeutic efficacy of Oorithalthaamarai Chooranam in the management of Madhumegha Noi muthalavathu avasthai - parutha udal (Diabetic Dyslipidemia).
The trial drug wilI be administered at the dose of 30 mg/ kg /BW/Twice a day A/F 90 days
along with water as adjuvant in 60 patients. The trial period of 12 months will be carrying out in
Government Siddha Medical College and Hospital Palayamkottai Tirunelvelli Tamilnadu. The
primary outcome will be evaluation of therapuetic efficacy of trial drug Oorithalthaamarai Chooranam.
The secondary outcome will be the evaluation of Siddha diagnostic parameters,assessment of
safety profile of trial drug, assessment of pharmacological and biochemical parameters of the trial
drug. In case of any adverse event (AE) is noticed and it will be referred to pharmacovigilance
department of SCRI. Further management of patient will be given in OPD facility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 31.00 Year(s) 至 68.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Type 2 diabetes mellitus 2.If yes in any of three As per ADA a.FBS.
- •> 126mg/dl and b.PPBS.
- •>140mg/d land c.HbA1c > 6.5 3.Secondary hyperlipidemia, Dyslipidemia has values as per NCEP a.Total cholesterol.
- •>199 mg/dl or b.LDL.
- •>100-129mg/dl or c.Triglycerides.
- •>150-199 mg/dl. d.HDL level.
- •â‰¤50-60 mg /dl 4.Willing to give blood sample for the investigations.
排除标准
- •1.If yes in any one of three a.FBS.
- •< 126mg/dl and b.PPBS.
- •<140mg/dl and HbA1c < 6.5 2.High lipid profile, dyslipidemia has values of, a.Total cholesterol <199 mg/dl b.LDL <100-130 mg/ dl c.Triglycerides <150-199 mg/dl d.HDL level -≥50-60 mg /dl 3.Type 1 diabetes mellitus 4.Severe Hypertension 5.Pregnancy 6.Lactating mother 7.Chronic kidney disease / Renal failure 8.Chronic active viral hepatitis/cirrhosis/ascites.
结局指标
主要结局
During treatment or after treatment,
时间窗: 90 days
FBS became 110mg /dl & PPBS160mg/dl and HbA1c 6.5.
时间窗: 90 days
Total cholesterol 199 mg/dl, LDL 159 mg/ dl and Triglycerides 150 mg/dl
时间窗: 90 days
次要结局
- 1.Evaluation of safety profile for acute& sub acute toxicity of the trial drug.(2.Evaluation of primary phytochemical analysis in different solvents.)