Multicenter clinical trial of the serum lipid-lowering effects of a Monascus purpureus (red yeast) rice preparation from traditional Chinese medicine

1997 ◽  
Vol 58 (12) ◽  
pp. 964-978 ◽  
Author(s):  
Junxian Wang ◽  
Zongliang Lu ◽  
Jiamin Chi ◽  
Wenhua Wang ◽  
Meizhe Su ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Serum Lipid ◽  
Monascus Purpureus ◽  
Lipid Lowering ◽  
Red Yeast Rice ◽  
Multicenter Clinical Trial ◽  
Red Yeast

scholarly journals Efficacy and Safety of Elian Granules in Treating Chronic Atrophic Gastritis: Study Protocol For a Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial

2021 ◽  
Author(s):  
Zhijian Gu ◽  
Jun Cong ◽  
Biao Gong ◽  
Rong Cen ◽  
Yongqi Chen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Atrophic Gastritis ◽  
Intestinal Metaplasia ◽  
Chronic Atrophic Gastritis ◽  
Efficacy And Safety ◽  
Multicenter Clinical Trial ◽  
Double Blind ◽  
Double Blind Placebo

Abstract Background: Multifocal atrophic gastritis and intestinal metaplasia are considered to be important links of the gastric precancerous cascade. But, there is a lack of definite therapeutic drugs for them. Many studies have shown traditional Chinese medicine is effective and no serious side effects have been identified. However, the studies that have been carried out were not scientifically rigorous trials. Our aim is to design a high-quality trial for a Chinese patent medicine, Elian granules, to investigate the efficacy and safety of this drug in treating chronic atrophic gastritis patients with or without intestinal metaplasia.Methods: This is a phase Ⅱ, randomized, double-blind, placebo-controlled, multicenter clinical trial. A total of 240 participants will be assigned to treatment group or placebo control group with a 1:1 ratio. Then, the experimental drug or placebo will be taken with boiling water,2 small bags (24.2g) each time, twice times a day, half an hour after each meal for 24 weeks. The primary outcome is to observe gastric mucosal histological changes after 6 months in patients with atrophic gastritis with or without intestinal metaplasia based on OLGA/OLGIM. The secondary outcome included dyspepsia symptom score and quality of life scale.Discussion: This study is designed to evaluate the efficacy and safety of Elian granule in a randomized, double-blind, placebo-controlled, multicenter manner. This trial may not only provide evidence for a phase III clinical trial, but also a vision of an alternative option for chronic atrophic gastritis(CAG) treatment.Trial registration: The registration number, ChiMCTR2000003929, was assigned by the Registry Platform For Evidence Based Traditional Chinese Medicine on 13 September 2020.

scholarly journals Calling for improved quality in the registration of traditional Chinese medicine during the public health emergency: a survey of trial registries for COVID-19, H1N1, and SARS

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Zhuoran Kuang ◽  
◽  
Xiaoyan Li ◽  
Jianxiong Cai ◽  
Yaolong Chen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Secondary Outcome ◽  
Specific Information ◽  
Clinical Trial Registry ◽  
Data Set ◽  
Diagnosis Criteria

Abstract Objective To assess the registration quality of traditional Chinese medicine (TCM) clinical trials for COVID-19, H1N1, and SARS. Method We searched for clinical trial registrations of TCM in the WHO International Clinical Trials Registry Platform (ICTRP) and Chinese Clinical Trial Registry (ChiCTR) on April 30, 2020. The registration quality assessment is based on the WHO Trial Registration Data Set (Version 1.3.1) and extra items for TCM information, including TCM background, theoretical origin, specific diagnosis criteria, description of intervention, and outcomes. Results A total of 136 records were examined, including 129 severe acute respiratory syndrome coronavirus 2 (COVID-19) and 7 H1N1 influenza (H1N1) patients. The deficiencies in the registration of TCM clinical trials (CTs) mainly focus on a low percentage reporting detailed information about interventions (46.6%), primary outcome(s) (37.7%), and key secondary outcome(s) (18.4%) and a lack of summary result (0%). For the TCM items, none of the clinical trial registrations reported the TCM background and rationale; only 6.6% provided the TCM diagnosis criteria or a description of the TCM intervention; and 27.9% provided TCM outcome(s). Conclusion Overall, although the number of registrations of TCM CTs increased, the registration quality was low. The registration quality of TCM CTs should be improved by more detailed reporting of interventions and outcomes, TCM-specific information, and sharing of the result data.

scholarly journals Gut microbiota: a potential target for traditional Chinese medicine intervention in coronary heart disease

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Tian-Yi Cheng ◽  
Jia-Xin Li ◽  
Jing-Yi Chen ◽  
Pei-Ying Chen ◽  
Lin-Rui Ma ◽  
...  
Keyword(s):  
Coronary Heart Disease ◽  
Heart Disease ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Gut Microbiota ◽  
Short Chain Fatty Acids ◽  
Lipid Lowering ◽  
China National Knowledge Infrastructure ◽  
Antiplatelet Aggregation ◽  
Single Target

AbstractCoronary heart disease (CHD) is a common ischaemic heart disease whose pathological mechanism has not been fully elucidated. Single target drugs, such as antiplatelet aggregation, coronary artery dilation and lipid-lowering medicines, can relieve some symptoms clinically but cannot effectively prevent and treat CHD. Accumulating evidence has revealed that alterations in GM composition, diversity, and richness are associated with the risk of CHD. The metabolites of the gut microbiota (GM), including trimethylamine N-oxide (TMAO), short-chain fatty acids (SCFAs) and bile acids (BAs), affect human physiology by activating numerous signalling pathways. Due to the advantage of multiple components and multiple targets, traditional Chinese medicine (TCM) can intervene in CHD by regulating the composition of the GM, reducing TMAO, increasing SCFAs and other CHD interventions. We have searched PubMed, Web of science, Google Scholar Science Direct, and China National Knowledge Infrastructure (CNKI), with the use of the keywords “gut microbiota, gut flora, traditional Chinese medicine, herbal medicine, coronary heart disease”. This review investigated the relationship between GM and CHD, as well as the intervention of TCM in CHD and GM, and aims to provide valuable insights for the treatments of CHD by TCM.

scholarly journals Improving the monacolin K to citrinin production ratio in red yeast rice by an X-ray-induced mutant strain of Monascus purpureus

2018 ◽  
Vol 99 (2) ◽  
pp. 109-118 ◽  
Author(s):  
Apinun Kanpiengjai ◽  
Rapeepun Mahawan ◽  
Prodpran Pengnoi ◽  
Saisamorn Lumyong ◽  
Chartchai Khanongnuch
Keyword(s):  
Mutant Strain ◽  
Monascus Purpureus ◽  
Red Yeast Rice ◽  
Monacolin K ◽  
X Ray ◽  
Production Ratio ◽  
Red Yeast ◽  
Induced Mutant

scholarly journals In VivoHypocholesterolemic Effect of MARDI Fermented Red Yeast Rice Water Extract in High Cholesterol Diet Fed Mice

2014 ◽  
Vol 2014 ◽  
pp. 1-7 ◽  
Author(s):  
Swee Keong Yeap ◽  
Boon Kee Beh ◽  
Joan Kong ◽  
Wan Yong Ho ◽  
Hamidah Mohd Yusof ◽  
...  
Keyword(s):  
Water Extract ◽  
Lipid Lowering ◽  
High Cholesterol Diet ◽  
Red Yeast Rice ◽  
Monacolin K ◽  
Cholesterol Diet ◽  
High Cholesterol ◽  
Red Yeast ◽  
Rice Water

Fermented red yeast rice has been traditionally consumed as medication in Asian cuisine. This study aimed to determine thein vivohypocholesterolemic and antioxidant effects of fermented red yeast rice water extract produced using Malaysian Agricultural Research and Development Institute (MARDI)Monascus purpureusstrains in mice fed with high cholesterol diet. Absence of monacolin-k, lower level ofγ-aminobutyric acid (GABA), higher content of total amino acids, and antioxidant activities were detected in MARDI fermented red yeast rice water extract (MFRYR).In vivoMFRYR treatment on hypercholesterolemic mice recorded similar lipid lowering effect as commercial red yeast rice extract (CRYR) as it helps to reduce the elevated serum liver enzyme and increased the antioxidant levels in liver. This effect was also associated with the upregulation of apolipoproteins-E and inhibition of Von Willebrand factor expression. In summary, MFRYR enriched in antioxidant and amino acid without monacolin-k showed similar hypocholesterolemic effect as CRYR that was rich in monacolin-k and GABA.

Sign in / Sign up

Export Citation Format

Share Document