A Randomized placebo controlled trial to evaluate the efficacy Of Parikara Yoga and Pathya in the Management of Yakrita Roga with special reference to Non-Alcoholic Fatty Liver Disease.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes in USG findings and grading at the end of 56 days
研究概览
简要总结
Over the past few decades Non-alcoholic fatty liver disease (NAFLD) is most common chronic liver disease in most part of the world it encompasses a spectrum of liver pathology with different clinical progress due to accumulation of triglycerides in hepatic cells. Non-alcoholic fatty liver disease (NAFLD) isindependent risk factor for metabolic syndrome and is associated with various metabolic risk factors including insulin resistance, dyslipidaemia, cardio-vascular disease, and most significantly obesity. Non-alcoholic fatty liver disease can remain harmless but, in some people, it may progress to non-alcoholic steatohepatitis (NASH). Non-alcoholic steatohepatitis is the progressive stage ofNon-alcoholic fatty liver disease.i When NAFLD progress to NASH it may eventually lead to complications such as cirrhosis of liver, liver cancer, liverfailure.
Non-alcoholic fatty liver disease can be interpreted as Santarpotha-vikara(disease which caused by taking excessive nourishing diet) which causesagnimandya, aamotpati and saamrasa formation and eventually lead to accumaltion of dosha in Yakrita.Parikara Yoga is mentioned in Chakradatta Yakritapleehaadhikarana 38/15-17. The Contents of Parikara Yoga have katu, tikta, kashaya rasa, ushna virya, laghu ruksha teekshna snigdha guna, katuvipaka ,kaphamedohar, raktaprasadaka, deepan and pachan properties. Most of the medicIine
NEED OF STUDY:
The treatment presently available are not satisfactory that can restrict hepaticsteatosis and to limit liver cell injury and the occurrence of inflammation and fibrosis. Currently it is a great challenge for us to develop a drug that is effective in Non-alcoholic fatty liver disease patients exhibiting, obesity, insulin resistance, dyslipidaemia and oxidative stress.Ultrasonography for detection of fatty liver has played a breakthrough role for patients with or without biochemical abnormalities. Therefore, this study was planned to assess the role of Parikara Yoga in Yakrita Roga with special reference to Non-alcoholic fatty liver disease [NAFLD].
AIM AND OBJECTIVES:
AIM: To assess the efficacy of Parikara Yoga and Pathya in the management of Yakrita Roga w.s.r. to non-alcoholic fatty liver disease.
OBJECTIVES:
Primary objective 1. Changes in USG findings and grading.
Secondary objective1. Changes in liver function test, lipid profile. 2. Changes in clinical sign and symptoms if any.
HYPHOTHESIS :
**1.Null Hypothesis [Ho]**There is no difference between the effect of trial drug Parikara Yoga and Placebo in the management of Yakrita Roga w.s.r. to Non-Alcoholic Liver Disease.
2.Alternative Hypothesis [H1]There is significant difference between the effect of trial drug ParikaraYoga and Placebo in the management of Yakrita Roga w.s.r. to NonAlcoholic Fatty Liver Disease. .
.
**POSOLOGY:**All the patient fulfilling the criteria of diagnosis and inclusion will be randomly divided into two groups named as Group A and Group B consisting 20 patients in each group.
Group A (Drug): 20 registered radiologically diagnosed patients of nonalcoholic fatty liver disease will be administered Parikara Yoga 1GM TID after meal, with anupana usnodaka with Pathya for 8weeks.
Group B (Placebo): 20 registered radiologically diagnosed patients of nonalcoholic fatty liver disease will be advised to Pathya with placebo (2 capsules each of 500mg filled with Roasted sooji powder) for 8 weeks.
Withdrawal Criteria:
..• Patients having any serious side effect even after enrolment in trial may be withdrawn from the study.
• Patient himself want to withdraw from the clinical trial
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
- 19.00 Year(s) 至 59.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex of age group >18years and <60 years with USG finding suggestive of fatty liver grade 1,2 and
- •2.Non-Alcoholic or patients with history of alcohol addiction less than 20gm per day in men and 10 gm per day in women.
- •Clinical sign and symptoms suggesting of Yakrita Roga/NAFLD that is, pain in right upper quadrant/ epigastric region of abdomen, feeling of nausea, heaviness in abdomen, flatulence ,loss of appetite and burning sensation in abdomen if any.
- •Patients with normal serum bilirubin level and ALT/AST level less than 1.5 times of normal limit.
- •Patients with/without raised lipid profile.
排除标准
- •Pregnant and lactating women.
- •Patients with history of diabetes mellitus, autoimmune hepatitis, drug abuse, chronic Hepatitis, raised ALT/AST level more than 1.5 times of normal limit.
- •Patients with complications of metabolic syndrome such as cerebrovascular accident, myocardial infarction, chronic kidney diseases, suffering from cirrhosis, ascites, variceal haemorrhage, coagulopathy, hepatorenal syndrome
- •Patient have any kind of malignancy.
结局指标
主要结局
Changes in USG findings and grading at the end of 56 days
时间窗: Changes in USG findings and grading at the end of 56 days
次要结局
- 1.Changes in liver function test, lipid profile at the and of 56 days(2. Changes in clinical sign and symptoms if any at the end of 60 days)