Effect Of Guduchyadi Choorna With Madhu As An Adjuvant To Lifestyle Modifications In Dyslipidemia
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1 Changes in Serum Total Cholesterol
研究概览
简要总结
Dyslipidemia iseither one or a combination of elevated total cholesterol, high LDL-C , low HDL-C, and elevated triglyceride . Dyslipidemia is amajor risk factor for coronary heart disease (CHD) . People with dyslipidemiaare at a twofold increased risk of developing CVD as compared to those withnormal lipid levels . CVD is becoming more prevalent globally and is one of theprominent causes of death . Raised levels of certain lipids in the bloodincrease the risk of atherosclerosis, which is recognized as the primary riskfactor for stroke, peripheral vascular, and CHD . Most (80%) of the lipid disorders areassociated with diet and lifestyle . Modifiable risk factors, including a diethigh in saturated or trans fats, sedentary lifestyle, smoking, and obesityincrease the risk of dyslipidemia . The prevalence of dyslipidemia is muchhigher among patients with coexisting cardiovascular risk factors such ashypertension, diabetes, or human immunodeficiency virus.According to WorldHealth Organisation(WHO) estimate in 2008 ,the prevalence ofdyslipedemia(defined as blood levels of TC190mg/dl)in the southeast Asia is30.3%, in Europe 53.7% and in America 47.7%. The prevalence of dyslipedemia isvery high in India also according to ICMR-INDIAB study,13.9% had hypercholestrolemia,29.5%had hypertriglyceridemia,72.3% had low HDL-C, 11.8% had high LDL-C levels and79% had abnormalities in one of the lipid parameters.Many interventional trialsreported to have hypolipidemic effect which give rapid temporary relief butcause long term side effects1. Herbals has much potential inpreventing lifestyle problems because of minimaladverse effects.Clinical importance of herbal drugs in the management ofdyslipidemis has received considerable attention in recent years.The studyaimed to explore the efficacy of Guduchyadi choornam with madhu along with Lifestyle modification indyslipidemia.In ayurveda ,it can be better correlated withmedodushti,associated with kaphadosa and dhatwagni mandhya,which is afunctional condition and just a precursor stage of medoroga and can be easilyreversible by effective regimen. Treatment of stoulya can be adopted fordyslipedemia which includeskapha , medohara ,deepana, pachana ,rukshana and lekhana karmas.Thestudy aimed to explore the efficacy of guduchi, triphalaand musta with madhu along with lifestyle modification in dyslipidemia.All thementioned drugs have the property mentioned above.
A Quaziexperimental study will be performed in 60 patients of bothsex,satisfying inclusion and exclusion criteria .Out of 60 patients , 30 eachwill be allocated to Intervention group(group 1) and Comparison group (Group2).The patients in the group 1 will be instructedto consume 6gm of Guduchyadichoorna with 12gm of madhu asanupana before food in morning and evening along with lifestyle modificationsuch as diet restrictions and exercise. Life style modification alone will beadvised to comparison group.The study period is fixed for 45 consequetive days.Theserum lipid profile will be analyzed before study and on 46th day and follow up will be done after the study period for 45 days .The data collected will be processed and conclusions will be made accordingly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 25.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Serum total cholesterol between 200mg/dl-239mg/dl 2.on ATP guidelines having LDL between 130mg/dl-159mg/dl 3.triglycerides 150mg/dl-199mg/dl 4.HbA1c below 7%.
排除标准
- •1.Known case of coronary Artery Disease 2.Known case of Thyroid and Renal disorders 3.Pregnant women and lactating women 4.Participants under any medication of dyslipidemia 5.Insulin dependent diabetic patients.
结局指标
主要结局
1 Changes in Serum Total Cholesterol
时间窗: 0th,46th, 90th day
2 Changes in LDL cholesterol
时间窗: 0th,46th, 90th day
3 Changes in Triglycerides
时间窗: 0th,46th, 90th day
4 HbA1C
时间窗: 0th,46th, 90th day
次要结局
未报告次要终点
