scholarly journals Efficacy and safety of ursodeoxycholic acid composite on fatigued patients with elevated liver function and/or fatty liver: a multi‐centre, randomised, double‐blinded, placebo‐controlled trial

2016 ◽  
Vol 70 (4) ◽  
pp. 302-311 ◽  
Author(s):  
B. Oh ◽  
W. S. Choi ◽  
S. B. Park ◽  
B. Cho ◽  
Y. J. Yang ◽  
...  
Keyword(s):  
Liver Function ◽  
Fatty Liver ◽  
Ursodeoxycholic Acid ◽  
Controlled Trial ◽  
Efficacy And Safety ◽  
Double Blinded

scholarly journals Efficacy and Safety of Hou Gu Mi Xi on Spleen Qi Deficiency in Patients with Nonorganic Gastrointestinal Disorders: Protocol for a Multicenter, Randomized, Placebo-Controlled Trial

2018 ◽  
Vol 2018 ◽  
pp. 1-8
Author(s):  
Xiaofan Chen ◽  
Heyun Nie ◽  
Wenjun Liu ◽  
Xu Zhou ◽  
Jianhua Nie ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Gastrointestinal Diseases ◽  
Ethics Committee ◽  
Gastrointestinal Disorders ◽  
Evidence Based ◽  
Research Model ◽  
Efficacy And Safety ◽  
Medical Treatments ◽  
Study Population ◽  
Double Blinded

Background. There is a worldwide epidemic of nonorganic gastrointestinal disorders (NOGDs), which are a class of disorders that cause various discomforts and ultimately progress into organic gastrointestinal diseases. Because of the unsatisfactory efficacy of Western medical treatments, traditional Chinese medicine (TCM) is becoming a promising complementary and alternative treatment to manage NOGDs. Objectives. To investigate the efficacy and safety of Hou Gu Mi Xi (HGMX), a newly developed dietary TCM formula, on the syndrome of spleen qi deficiency (SQD) in patients with NOGDs. Methods/Design. This study is a multicenter, randomized, double-blinded, parallel, and placebo-controlled trial that will last for 2 years. All qualified subjects with NOGDs and SQD will be included. The study population will be divided into the HGMX and placebo groups. To assess the efficacy of HGMX, we will mainly focus on changes in SQD symptoms scored by a Spleen Qi Deficiency Symptoms Grading and Quantifying Scale and evaluate changes in gastrin-17, the negative Helicobacter pylori conversion rate, body weight, body mass index, and gastroscopy findings. The safety of HGMX will be assessed by recording adverse events (AEs), severe AEs, treatment-related AEs and withdrawal due to AEs. Discussion. This trial is part of our study series that intends to validate the potential of HGMX in the management of chronic gastrointestinal diseases. This series of RCTs is the first committed to the evaluation of a dietary TCM formula and will hopefully establish an evidence-based clinical research model for dietary TCM formulas. Ethics. The protocol was approved by Ethics Committee of five research hospitals and was registered in Clinicaltrials.gov (NCT03019042).

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

2020 ◽  
Author(s):  
Jing-juan Xu ◽  
Rui-rui Wang ◽  
Sheng-fu You ◽  
Lei Zhang ◽  
Pei-yong Zheng ◽  
...  
Keyword(s):  
Liver Disease ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Liver Function ◽  
Fatty Liver ◽  
Fatty Liver Disease ◽  
Clinical Symptoms ◽  
Efficacy And Safety ◽  
Alcoholic Fatty Liver ◽  
Alcoholic Fatty Liver Disease

Abstract 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.

scholarly journals The pharmacokinetics, efficacy, and safety of a novel selective‐dose cannabis inhaler in patients with chronic pain: A randomized, double‐blinded, placebo‐controlled trial

2020 ◽  
Vol 24 (8) ◽  
pp. 1505-1516
Author(s):  
Shlomo Almog ◽  
Judith Aharon‐Peretz ◽  
Simon Vulfsons ◽  
Miri Ogintz ◽  
Hadas Abalia ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Controlled Trial ◽  
Efficacy And Safety ◽  
Double Blinded
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