Key result
Lingguizhugan decoction will be evaluated for its efficacy in reducing HOMA-IR in patients with non-alcoholic fatty liver disease and spleen-yang deficiency pattern in a planned randomized trial.
Why the study?
Traditional Chinese medicine shows potential in treating NAFLD, but the efficacy, safety, and optimal dosage of Lingguizhugan decoction for NAFLD with spleen-yang deficiency pattern need examination.
Does Lingguizhugan decoction improve insulin resistance in patients with non-alcoholic fatty liver disease with spleen-yang deficiency pattern?
RCT (n=243)
Double-blinded
1:1:1
Yes
Does Lingguizhugan decoction improve insulin resistance in patients with non-alcoholic fatty liver disease with spleen-yang deficiency pattern?
This study protocol outlines a trial to evaluate the efficacy of Lingguizhugan decoction for improving insulin resistance in NAFLD patients.
Answers are grounded in this paper and cite their sources.
Planned RCT will test Lingguizhugan decoction on HOMA-IR in NAFLD; leaves open its efficacy until results are available.
Background: Nonalcoholic fatty liver disease (NAFLD) is a metabolic stress liver injury induced by excessive fat accumulation in liver, which is closely related to insulin resistance (IR). Traditional Chinese medicine (TCM) has showed good curative effects and unique advantages in the prevention and treatment of NADLD, particularly in improving IR, liver function and clinical symptoms. This study will examine the efficacy and safety of Lingguizhugan decoction (LGZG) in the treatment of non-alcoholic fatty liver disease with spleen-yang deficiency pattern, and assess the optimal dosage. Methods/design: This study is a three-arm, dose-optimization, randomized, double-blinded, placebo-controlled clinical trial. A total of 243 NAFLD patients will be recruited and randomly assigned to standard dose Lingguizhugan decoction (SLGD) group, low dose Lingguizhugan decoction (LLGD) group, or the control group. The clinical indicator will be assessed during the 12-week intervention and follow-up 4 weeks. The primary outcome is the percentage of patients whose the decline of HOMA-IR reaches one standard unit. Secondary outcomes include body weight, body mass index, liver function, blood lipid metabolism, blood glucose metabolism, liver-kidney echo ratio, quantitative rating of clinical symptoms and signs, collecting sample(s) from participants, the medical outcomes study(MOS) item short from health survey(SF-36), Self-rating Depressive Scale(SAS), and Self-rating Anxiety Scale(SDS). Discussion: This study will provide initial evidence regarding the efficacy and safety of LGZG in the treatment of NAFLD with spleen-yang deficiency pattern, meanwhile establish the demonstration technique, and promote its application in community healthcare center. In addition, potential mechanism will be explored based on research of oral and gut microbiota. Trial registration: Chinese Clinical Trial Registry, ID: ChiCTR1800014364. Registered on 01 January 2018. The final protocol version was V3.0.
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Xu et al. (2019) conducted an RCT in Non-alcoholic fatty liver disease (NAFLD) with spleen-yang deficiency pattern (n=243). Lingguizhugan decoction vs. Placebo was evaluated on Proportion of participants with at least one-unit decrease of HOMA-IR from baseline to treatment endpoint (week 12). Lingguizhugan decoction will be evaluated for its efficacy in reducing HOMA-IR in patients with non-alcoholic fatty liver disease and spleen-yang deficiency pattern in a planned randomized trial.
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