Efficacy of Sharapunkhadi powder (a polyherbal formulation) and lifestyle modification in the management of nonalcoholic fatty liver disease-A randomized placebo-controlled clinical trial.

Ayu Pub Date : 2020-04-01 Epub Date: 2021-10-23 DOI:10.4103/ayu.AYU_281_19
E Remya, Mandip Goyal, Jitendra Varsakiya
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引用次数: 2

Abstract

Background: Nonalcoholic fatty liver disease (NAFLD) is an expanding health problem, which varies in prevalence among ethnic groups, occurring with an estimated global prevalence of 25%. In high-risk populations, the prevalence of NAFLD may be as high as 70%-90%. No established pharmacological treatment is available for NAFLD in modern medicine and hence, there is a search for alternative treatment modalities in other systems of medicine, which is safe and cost-effective.

Aim: The aim is to evaluate the efficacy of Sharapunkhadi powder and lifestyle modification in the management of NAFLD.

Materials and methods: Patients suffering from any of the components of metabolic syndrome, i.e. hypertension, diabetes mellitus, hypertriglyceridemia, elevated body mass index (>25 kg/m2), truncal obesity, or presenting with the symptoms of indigestion, abdominal discomfort, flatulence. were screened with liver function tests and ultrasonography (USG) of the abdomen. A total of 93 patients confirmed with fatty liver Grade 1-3 were selected for the present trial and were randomly divided into two groups. After Mridu Virechana (mild purgation) with Haritaki powder (6-8 g) according to Koshtha, in group A (n = 46), 2 capsules (500 mg each) filled with Sharapunkhadi powder thrice a day before food with warm water along with lifestyle modification were administered for 8 weeks. In group B (n = 47), capsules filled with roasted Sooji powder in the same dose as mentioned for group A was given along with lifestyle modification and were maintained as a placebo. Relief in subjective parameters such as indigestion, abdominal discomfort, and flatulence and improvement in the grades of fatty liver evident from USG was considered for the overall assessment of the therapy in both the groups. SigmaStat 3.1 software was used for statistical calculation. Wilcoxon signed-rank test for subjective criteria and Student's paired t-test for objective criteria were applied to check the level of significance in a single group before and after treatment, while Student's unpaired t-test for objective criteria was applied to assess the level of significance of difference observed between two groups.

Results: After 8 weeks of treatment, it was found from USG findings that there was a statistically significant improvement by about 39.25% in group A and 31.82% in group B, in the grade of fatty liver. The combination of Sharapunkhadi powder along with lifestyle modification provided comparatively better relief in subjective and objective parameters over the placebo control group.

Conclusion: Sharapunkhadi powder is a promising herbal preparation for the management of NAFLD and the combination of Sharapunkhadi powder along with lifestyle modification can yield more significant results in the management of NAFLD than lifestyle modification alone.

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Sharapunkhadi散(一种多草药制剂)和生活方式改变在治疗非酒精性脂肪肝中的疗效——一项随机安慰剂对照临床试验
背景:非酒精性脂肪性肝病(NAFLD)是一个不断扩大的健康问题,其患病率在不同种族群体中有所不同,估计全球患病率为25%。在高危人群中,NAFLD的患病率可高达70%-90%。现代医学没有针对NAFLD的既定药物治疗方法,因此,需要在其他医学系统中寻找安全且具有成本效益的替代治疗方式。目的:评价Sharapunkhadi散配合生活方式改变治疗NAFLD的疗效。材料和方法:患有代谢综合征任何组成部分的患者,如高血压、糖尿病、高甘油三酯血症、体重指数升高(>25 kg/m2)、躯干肥胖或有消化不良、腹部不适、胀气等症状的患者。通过肝功能检查和腹部超声检查(USG)进行筛查。本试验共选择93例确诊为1-3级脂肪肝的患者,随机分为两组。根据Koshtha的说法,在Mridu Virechana(轻度净化)与Haritaki粉(6-8 g)后,A组(n = 46),每天三次服用2粒胶囊(每粒500 mg),填充Sharapunkhadi粉,然后用温水喂食,同时改变生活方式,持续8周。在B组(n = 47)中,给予与A组相同剂量的烘烤Sooji粉胶囊,同时改变生活方式,并作为安慰剂维持。主观参数如消化不良、腹部不适和胀气的缓解以及USG中脂肪肝等级的改善被认为是对两组治疗的总体评估。采用SigmaStat 3.1软件进行统计计算。主观标准采用Wilcoxon sign -rank检验,客观标准采用Student’s配对t检验检验单组治疗前后的显著性水平,客观标准采用Student’s unpaired t检验评价两组间差异的显著性水平。结果:治疗8周后,USG结果显示,a组脂肪肝分级改善约39.25%,B组脂肪肝分级改善约31.82%,有统计学意义。与安慰剂对照组相比,Sharapunkhadi粉联合生活方式改变在主观和客观参数上提供了相对更好的缓解。结论:Sharapunkhadi散是治疗NAFLD的一种很有前途的中药制剂,Sharapunkhadi散联合生活方式改变治疗NAFLD的效果比单独改变生活方式更显著。
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