A randomized open-labelled comparative clinical study to evaluate the efficacy of Navanga Kwath with Vitamin E in the management of Non-Alcoholic Fatty Liver Disease(Yakritroga)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction in scoring pattern of sign and symptoms such as Tastelessness, Indigestion, Mild pain in the upper abdomen, Feeling of heaviness, Diminution of the agni, Feeling of nausea and vomiting, Fatigue
研究概览
简要总结
Non–alcoholic fatty liver disease represents a spectrum of liver disease encompassing simple fatty infiltration, inflammation and cirrhosis, in the absence of excessive alcohol consumption. The global prevalence of NAFLD is estimated to 24%. Vitiation of agni caused by Raktadhatu Dushti and Kapha dosha leads to formation of ama rasa or apakva anna rasa. Kapha dushti causes impaired metabolism of fat resulting in the deposition of excessive fat (Medas) in the liver. Most common symptoms such as Avipaka, Agnimandya, Aruchi, Utklesha, Mandavyatha, Gaurvanvita, etc. Based on all these signs and symptoms of NAFLD patients it can be correlated with Agnivikrita, Yakritroga and Medodushti vikara. Through the proper administration of Ayurvedic treatment protocol along with life style modification progression of this disease can be prevented. Accordingly, a study will be conducted with the aim to compare the efficacy of Navanga Kwatha and Vitamin E in the management of NAFLD (Yakritroga) for which 60 patients will be randomly selected and divided into two groups. In group A (30 patients) 24 ml of Navanga Kwatha (Intervention) will be given after meal three times a day for 42 days. In group B (30 patients) 400mg Vitamin E will be given with water after meal twice a day for 42 days. Patient will be regularly followed up on 0th, 7th, 14th, 21th, 28th, 35th, 42th (during treatment) and 56th and 70th day (post treatment). Clinical features and laboratory parameters will be analyzed during and after treatment and result will be analyzed using appropriate statistical methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 25.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •The patient presented with cardinal features of Yakritroga as described in Ayurvedic texts.
- •Randomly selected irrespective of their caste, religion and sex.
- •Patient with the age group of age of 25-60 years.
- •Voluntary agreement & and enrolment to participate in the study.
- •The ratio of AST/ALT below
- •Non-alcoholic Fatty Liver Disease patient who was diagnosed by abdomen ultrasonic examination and non-drinker or total abstainer or with alcohol intake of less than 20 gm per day for females and less than 30 gm per day for males.
- •NAFLD confirmed by USG with or without having symptoms like fatigue and mild discomfort in the upper quadrant of the abdomen.
排除标准
- •1 Patient below 25 years and above 60 years of age 2 The ratio of AST or ALT over 2 3 Metabolic syndromes such as Type I and II Diabetes Mellitus Hypertension Cerebrovascular Accident Myocardial Infarction and Chronic Kidney Disease 4 Any dysfunction of the liver besides Non Alcoholic Fatty Liver Diseases like Viral Hepatitis Liver Parenchymal Disease Ascites portal Hypertension Hepato Cellular Carcinoma Auto Immune Hepatitis Primary Biliary Cirrhosis Wilsons Disease and liver Transplantation or any other conditions interfering with the result of the treatment of non alcoholic fatty liver disease patient
- •Prior treatment with any medicine that affects the treatment of Non Alcoholic Fatty Liver Disease within 3 months 6 Patient suffering from HIV TB other infectious diseases Malignancies Major Psychiatric Problems or any other serious problems
- •Patient on prolonged (more than 6 weeks) medication with corticosteroids antidepressants anticholinergic hepatotoxic medicines or any other drug that may influence the outcome of The study 8 Alcoholics and any other drug abusers 9 Pregnant and Lactating women 10 The patient has a history of Hypersensitivity to the trial drug or any of its ingredients.
结局指标
主要结局
Reduction in scoring pattern of sign and symptoms such as Tastelessness, Indigestion, Mild pain in the upper abdomen, Feeling of heaviness, Diminution of the agni, Feeling of nausea and vomiting, Fatigue
时间窗: 42 days
次要结局
- Improvement in haematological parameters such as Serum cholestrol, Serum trigylcerides, SGPT, SGOT, Alkaline Phosphatase(70 days)
研究者
DR DIVYA
Institute for Ayurved studies and research SKAU Kurukshetra
