Efficacy of Amritadi Guggulu and Phalatrikadi Kwatha along with lifestyle modification in the management of Atherogenic Dyslipidemia- An open labelled single arm exploratory trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Correction in Lipid profile (Mean reduction in the levels of Sr.Triglycerides and Sr.LDL while increase in Sr.HDL level)
研究概览
简要总结
The trial is exploratory clinical trial to evaluate the role of oral administration of Amritadi Guggulu and Phalatrikadi Kwatha along with lifestyle modification in the management of Atherogenic Dyslipidemia. Total 30 patient fulfilling diagnostic criteria and inclusion criteria will be enrolled in the study. Selected patients will be administrated Amritadi Guggulu (3 tablets of 500 mg each), twice a day, orally at early in the morning empty stomach before breakfast and after 5 hours of lunch along Phalatrikadi Kwatha (40 ml each time) as an Anupana for duration of 8 weeks. The haematological investigations, liver function tests, renal function tests, urine routine, ECG will be done before the trial while lipid profile and biomarker of dyslipidemia: Apolipoprotein-B will be done before and after trial. Proper dietary and physical regimen will be advised to all the patients. Patients will be advised to visit the hospital every fortnightly during the treatment for 8 weeks and after the completion of the therapy for the duration of 2 weeks at every week as a follow up.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age from 30 to 60 years, irrespective of gender, caste, religion and socioeconomic status.
- •Patient fulfilling diagnostic criteria (According to National Cholesterol Education Program, Adult Treatment Panel III- Sr.Triglycerides above 150 mg/dl, Sr.LDL above 100 mg/dl, Sr.HDL below 40 mg/dl)
- •BMI from 18.5 to 34.9 kg/m2 (Normal, overweight, obese class I)
- •Newly diagnosed cases of Atherogenic Dyslipidemia but not taking any Hypolipidemic drugs and previously diagnosed cases, inspite of taking hypolipidemic drugs fulfilling diagnostic criteria can be selected after giving proper washout period.
- •Patient willing for trial and ready to give written consent.
排除标准
- •Age group below 30 years and above 60 years.
- •Lipid profile with very high level (Sr.Triglyceride above 499 mg/dl, Sr.LDL above 190 mg/dl.
- •BMI below 18.5 and above 34.9 kg/m2
- •Patient suffering from type I DM, poorly controlled DM type II (RBS above 200), poorly controlled HTN (Systolic BP above 160 mm of Hg, Diastolic BP above 100 mm of Hg), known cases of Hypothyroidism.
- •Patient with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities.
- •Patients with history of myocardial infraction, stroke or has undergone coronary artery bypass surgery, percutaneous transluminal coronary angioplasty or unstable or severe peripheral artery disease.
- •Drug induced hyperlipidemia (Glucocorticoids, diuretics)
- •Patient suffering from major systemic illness necessitating long term treatment (RA, PTB, malignancy, ARD, CKD)
- •Alcoholic or drug abuse patients.
- •Patient on oral contraceptives, pregnant female or planning for pregnancy, lactating mother.
结局指标
主要结局
Correction in Lipid profile (Mean reduction in the levels of Sr.Triglycerides and Sr.LDL while increase in Sr.HDL level)
时间窗: 8 weeks
次要结局
- 1. Reduction in BMI.(2. Reduction in Apolipoprotein B.)
研究者
Shravani Uday Mahajan
Institute of Teaching and Research in Ayurveda Jamnagar