A Comparative Study to Evaluate the Efficacy of Sharpunkha churna and Sharpunkhadi churna in the management of Metabolic Dysfunction- Associated Fatty Liver Disease (~Yakrit Vikara)
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
研究概览
简要总结
Metabolic Dysfunction- Associated Fatty Liver Disease (MAFLD) is an umbrella term for theliver diseases that are characterized primarily by storage of excess macro vesicular fat (>5% of the hepatocytes) because of a perturbation of the homeostatic mechanism that regulate thesynthesis versus utilization of fat in the liver. It show symptoms of Udarshool (right upper quadrant/ epigastric region of the abdomen)Hrullas (feeling of nausea and vomiting)Aruchi (loss of appetite) Klama (fatigue) Koshtha Daah (Burning sensation of abdomen).The prevalence of Metabolic Dysfunction- Associated Fatty Liver Disease in India is estimated to be 9% and 32% of general population.With a greater frequency among individuals who are overweight or obese and those who have diabetes or pre-diabetes.The present study aims to evaluate the role of sharpunkha churna and sharpunkhadi churna in reduction in the primary assessment parameter i.e. NAFLD fibrosis score. total number of patients are 64, 32 in each group. in Group A, Sharpunkha Churna will be only administered at the dose of 3gm twice a day with Cow butter milk (100ml) 2 hours before meal. in Group B, Sharpunkhadi Churna will be only administered at the dose of 3gm twice a day with luke warm water 2 hours before meal. The design of study is Single centered, Open labelled, Randomised Comparative, Interventional study.
[i] Prajakta Ankur Vangurmekar, Agnelo Mnino Ferreir. Prevalence of non-alcoholic fatty liver (MAFLD)among adults in uban Goa. NMJI2022 36(6);401-404
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 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
- •1.Patient with NFS -1.455 or greater than -1.
- •2.Patient with positive clinical history of Metabolic Dysfunction- Associated Fatty Liver Disease Grade 1 and Grade
- •3.Patient with classical symptoms suggesting of NAFLD/ Yakrit vikara that is Udarshool (pain in right upper quadrant/ epigastric region of the abdomen), Hrullas (feeling of nausea and vomiting), Arochak (loss of appetite), Klama (fatigue), Koshtha Dah (burning sensation in the abdomen).
- •4.Patient having age between 25 to 60 years with irrespective of gender.
- •5.Subject who are able to take medicine orally.
- •6.Subject who are willing to sign consent.
- •7.Patient with LFT showing raised ALT (Alanine transaminase level approximately more than 1.5 times the normal limit with/ without raised lipid profile and fasting blood glucose level within normal limit).
排除标准
- •1.Patient with history of alcohol intake.
- •2.Pregnant and lactating female.
- •3.Patient with positive markers of other liver diseases such as viral hepatitis, autoimmune hepatitis, Wilson’s disease.
- •4.Subject with concomitant hepatotoxic and anti-dyslipedemic drugs.
研究者
Dr Amreen
Ch. Brahm Prakash Ayurved Charak Sansthan