Clinical Efficacy and safety of Arogyavardhini Vati and Pippalyadyasava in the management of Non-Alcoholic Fatty Liver Disease (NAFLD) –An open level prospective clinical trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To assess the change in fibroscan score (Kpa) and CAP value (Kpa) or MRI-PDFF
研究概览
简要总结
Non-alcoholic fatty liver disease (NAFLD) is currently the most common chronic liver disease in developed countries because of the obesity epidemic. Approximately 25% of the world’s population suffers with NAFLDNon-alcoholic fatty liver disease (NAFLD) is currently the most common chronic liver disease in developed countries because of the obesity epidemic. Approximately 25% of the world’s population suffers with NAFLDThe main goals of treatment are to improve steatosis and to prevent progression of the disease. Intense lifestyle modification and treatment of the risk factors are the cornerstones of disease management. Ayurveda is a holistic science that give prime importance to diet and regimen in maintenance of health and prevention of disease. The aetio-pathogenesis of NAFLD points toMedodhatuDushti, DhatwagniMandyawith or withoutconcurrentRakta Dhatu Dushti. Liver is considered as the seat of DhatwagniPaka and any disease afflicting liver or Rakta will produce DhatwagniMandyain the level of Mamsa and Medas. Considering this, two drugs with action on liver and Medashas been selected for this study.
Arogyavardhini Vati(AVR) is a Kharaliya Rasaushadhi(formulations containing metallominerals and mercurials) used for the treatment of different types of Jvara (fever), Kushtha(skin disorders), Medoroga (obesity), and other Yakritvikara (liver disorders)[i]. It has been described in the 13th-century text by Rasa Vagbhata[ii]. Previous study suggests the role of AVR in acute viral hepatitis and possesses significant effects on cytoprotection and recovery of the liver function[iii] and hepatoprotective effect against CCl4-induced liver injury[iv]. Pippalyadyasava contains drugs which are predominantly Katu and Tikta in Rasa (taste), Laghu and Ruksha in Guna(property), Katuin VipakaandUshna in Virya (potency). They mainly act as Deepana and Pachana and thus correct the Agni Mandya
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed cases of Grade- I&II of Non-alcoholic fatty liver disease as evident fatty infiltration on Ultrasound.
- •Either sex aged between18- 60 years.
- •Subjects of non-alcoholic fatty liver disease with their hepatic enzymes <2 times upper normal limit (Normal limits AST 5-40U/L and ALT 7-56U/L).
- •Willing to provide written consent and able to participate for 4 months in the study.
排除标准
- •H/o habitual consumption of alcohol intake of >20g/day for women,>40g/day for men Any other identified cause of chronic liver disease The use of medication which would cause non-alcoholic fatty liver.
- •disease e.g. tamoxifen Already taking supplementary medicine for NAFLD On anticoagulants (antiplatelet aggregators are permitted) Past history of Cardiac Arrhythmia, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months. Symptomatic patients with clinical evidence of congestive cardiac failure. Subjects with concurrent Renal Dysfunction (defined as S. creatinine> 1.2 mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease. Uncontrolled Diabetes Mellitus (HbA1C>8) Known cases of HIV and AIDS, malignancy, Hepatitis B Subjects participated in any other clinical trial. Women who are planning for conception / pregnant or lactating.Any other condition which the P.I. thinks may jeopardize the study.
结局指标
主要结局
To assess the change in fibroscan score (Kpa) and CAP value (Kpa) or MRI-PDFF
时间窗: Baseline& 90th day
次要结局
- To assess changes in ALT, AST, Serum bilirubin, Total proteins & Alkaline Phosphatase(Changes in Lipid profile)