Traditional Chinese medicine Lingguizhugan decoction treating non-alcoholic fatty liver disease with spleen-yang deficiency pattern: Study protocol for a multicenter randomized controlled trial

Abstract

Background Non-alcoholic fatty liver disease (NAFLD) is a common chronic liver disease characterized by excessive fat accumulation in the liver. One of the underlying pathophysiological mechanisms is insulin resistance (IR). Traditional Chinese medicine (TCM) has showed potential benefits in the management of NAFLD. Lingguizhugan decoction (LGZG) is a representative Chinese herbal formula; however, there is still no rigorous clinical trial supporting its application. Methods/design This study will be a three-arm, dose-optimization, randomized, double-blinded, placebo-controlled clinical trial. A total of 243 patients with NAFLD will be recruited and randomly assigned to the standard dose LGZG (SLGD) group, low dose LGZG (LLGD) group, or the placebo group based on a ratio of 1:1:1. The treatment period will be 12 weeks and the follow-up period will last 4 weeks. The primary outcome will be the proportions of participants with at least a 1-unit decrease of HOMA-IR from baseline to 12 weeks. Secondary outcomes will include the changes of body weight, body mass index, liver function, blood lipid metabolism, blood glucose metabolism, inflammatory responses, liver-kidney echo ratio by ultrasound, and various scales. Biological samples will also be collected for future researches on mechanism exploration. Discussion This study will provide initial evidence regarding the efficacy and safety of LGZG in the treatment of NAFLD with spleen-yang deficiency pattern and promote its application in community healthcare centers. In addition, potential mechanisms will be explored based on studies of oral and gut microbiota. Trial registration Chinese Clinical Trial Registry, ChiCTR1800014364. Registered on 1 January 2018. The final protocol version was V3.0.

Phytochemical Analysis Using UPLC-MS/MS Combined with Network Pharmacology Methods to Explore the Biomarkers for the Quality Control of Lingguizhugan Decoction

“…Modern pharmacological studies have revealed that LGZG has a variety of biological and pharmacological properties, such as the regulation of cardio-cerebrovascular function [ 1 ], regulation of lipid metabolism and blood circulation [ 2 ], and anti-inflammation effects [ 3 ]. At present, LGZG has been widely used in clinics for the prevention and treatment of heart failure [ 4 ], acute myocardial infarction [ 5 ], nonalcoholic fatty liver [ 6 ], obesity [ 7 ], hyperlipidemia [ 8 ], gastrointestinal function regulation [ 9 ], and many other diseases [ 10 , 11 ]. However, combined with the present stage of research, most of the studies on LGZG have been restricted to the main research index of licorice-related components, while the related components in other herbal medicines are rarely involved, or the overall quality evaluation indexes are not comprehensive, or the range of mass error is excessive, which results in a limited accuracy [ 12 , 13 ].…”

Yishentongluo decoction in treatment of idiopathic asthenozoospermia infertility

“…Treatment based on syndrome differentiation is the most representative character of TCM in recognizing and treating diseases. [ 50 ] Therefore, we regard syndrome differentiation as one of the inclusion criteria of participants, namely kidney deficiency and blood stasis. YSTL has been proved as an effective prescription for treating male infertility diagnosed for kidney deficiency and blood stasis.…”

Clinical Experience of Acupuncture Treatment for Non-Alcoholic Fatty Liver Disease

“…Reflecting the pathological importance of the spleen, the signs and symptoms of NAFLD are mostly the manifestations of splenic failure. In the treatment of NAFLD, spleen strengthening should be the entry point [10,11]. e spleen and stomach are the foundation of the acquired nature and the source of Qi and blood metaplasia, which can directly affect patient recovery and the outcome of the disease.…”