A Randomized Controlled Trial to evaluate the effect of Eranda Moola(Root of Ricinus communis) in the management of Dyslipidemia
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- 1) Effect on the change in direct LDL-C level at the end of study (08 weeks)
研究概览
简要总结
Current study is openlabeled, two arms, randomized controlled clinical trial. Purpose of the Study: RecentPopulation study shows higher prevalence of Dyslipidemia in overall Indian population alongwith Hypertension and Diabetes. Dyslipidemia an unnoticedclinical entity most of the time detected accidently. It is a need of time to explore natural originlipid lowering agent with good efficacy. So it is a matter of interest to evaluate theeffect of Erand Moola in management of Dyslipidemia. Complex or combined treatment modalities areeffective in management but it is difficult or expensive for patient to followor perform for long period of time. On the contrary compliance is best fornatural origin lipid lowering agent which is cost effective, handy and freefrom side effects in the management of dyslipidemia. Acharya Bhavmishra, in histext Bhavprakash mentioned the use of Eranda moola along with honey in Sthoulya and pharmacological study also proved its lipid lowering properties.But still there is no clinical trial reported regarding the lipid loweringactivity of Eranda moola. Hence it is decided to evaluate the effect of ErandaMoola as a lipid lowering agent in the management of dyslipidemia.
Erand Moola is used in Ayurveda for Paachak, Shothghna,VataKaphaghna and Vrishyaproperties since ancient time. Drug Safety and Toxicity study also establishedits safe use. Hence it’s ethical to use Eranda moola in the managementof Dyslipidemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with Direct LDL-C more than 130 at the time of screening Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
排除标准
- •Subjects not willing for trial 2)Subjects with Diabetes Mellitus Type I and Type 2 Diabetes Mellitus 3)Subjects with uncontrolled Hy pothyroidism or Hyperthyroidism 4)Known cases of Severe/Chronic hepatic or renal disease 5)Known subject of any active malignancy 6)Subjects giving history of significant cardiovascular event less than 12 weeks prior to randomization 7)Subjects with uncontrolled or Malignant Hypertension 8)Subjects ECG demonstrating any signs of uncontrolled arrhythmia or acute ischemia 9)Subjects X- ray chest showing any active lesion of tuberculosis 10)Subjects having known HIV infection 11)Subjects using any other investigational drug within 1 month prior to recruitment 12)Pregnant and Lactating females 13)Subjects currently participating in any other Clinical study 14)Any other medical or surgical condition considered unsuitable for patient participation in the study as per Investigator’s judgment.
结局指标
主要结局
1) Effect on the change in direct LDL-C level at the end of study (08 weeks)
时间窗: at the end of 8 weeks
2)Effect on the change in Triglycerides levels at the end of study (08 weeks)
时间窗: at the end of 8 weeks
次要结局
- 1.Change in Total Cholesterol Triglycerides LDL and HDL at the end of 4 and 8 weeks(2.Change in Body Weight BMI Waist circumference and Waist to hip ratio at the end of 4 & 8 weeks)