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 Acute Efficacy of a Traditional Chinese Medicine for Treatment of Frequent Premature Ventricular Contractions in Patients with Concomitant Sinus Bradycardia: Results from a Double-Blind, Placebo-Controlled, Multicentre, Randomized Clinical Trial

2019 ◽  
Vol 2019 ◽  
pp. 1-8 ◽  
Author(s):  
Fengxiang Zhang ◽  
Jiangang Zou ◽  
Hao Yu ◽  
Xiaorong Li ◽  
Pipin Kojodjojo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Randomized Clinical Trial ◽  
Beta Blockers ◽  
Sinus Bradycardia ◽  
Antiarrhythmic Therapy ◽  
Double Blind ◽  
Premature Ventricular Contractions ◽  
Double Blind Placebo

Pharmacological antiarrhythmic therapy such as beta-blockers in patients with frequent premature ventricular contractions (PVCs) and concomitant bradycardia is challenging. A traditional Chinese medicine, Shensong Yangxin (SSYX), has been effective in treatment of frequent PVCs and sinus bradycardia (SB) in separate patient cohorts. This double-blind, placebo-controlled, multicentre, randomized clinical trial investigates the acute efficacy of SSYX in reducing PVCs burden in patients with concomitant SB. Patients with symptomatic, frequent PVCs, and SB, defined as mean heart rate (MHR) of 45 to 59 beats per min (bpm), were recruited at 33 medical centres in mainland China and randomly assigned by computer to either SSYX or matching placebo for eight weeks. Patients, investigators, and trial personnel were masked to treatment allocation. Primary endpoints were changes in PVCs burden and MHR as assessed by 24-hour Holter monitoring relative to baseline. Secondary efficacy endpoints were subjective symptom score, ECG, and biochemical parameters. Analysis was based on intention-to-treat principles. 333 patients were randomized, of which 166 received SSYX and 167 placebo. Baseline characteristics did not differ. SSYX reduced PVCs burden by 68.2% (p < 0.001) and increased MHR by 10.9% (p < 0.001) compared to 32.2% and 4.7%, respectively, in the placebo group. SSYX group experienced greater symptomatic improvement (p < 0.001). No differences in reported adverse events were seen (20 versus 23). SSYX is an effective antiarrhythmic therapy for symptomatic, frequent PVCs uniquely suited patients with concomitant SB. Clinical trial number was NCT01750775.

Mechanism of E Lian Granule Reversing Chronic Atrophic Gastritis With Intestinal Metaplasia Based on Integrated Pharmacology and GEO Gene Chip

2021 ◽  
Author(s):  
Sizhen Gu ◽  
Yan Xue ◽  
Shigui Xue ◽  
Yini Tang ◽  
Zhehao Hu ◽  
...  
Keyword(s):  
Molecular Docking ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Atrophic Gastritis ◽  
Intestinal Metaplasia ◽  
Precancerous Lesions ◽  
Chronic Atrophic Gastritis ◽  
Network Computing ◽  
Active Components ◽  
Gene Chips

Abstract Background: This study aimed to explore the main components and targets of E-Lian granule through which it reversed chronic atrophic gastritis with intestinal metaplasia, based on the traditional Chinese Medicine Integrated Pharmacology Network Computing Research Platform V2.0 (TCMIP V2.0) combined with GEO gene chips. It also aimed to construct various networks to predict and analyze the mechanism of E-Lian granule in treating gastric precancerous lesions. Methods: The effective traditional Chinese medicine components and targets of E-Lian granule prescription were obtained using TCMIP V2.0. The disease targets were collected using the TCMIP V2.0 platform and the verified gene chips in the GEO database, and the “drug components–targets” network, “compound–targets protein interaction network,” and “core compound targets–pathways network” were constructed using Cytoscape 3.6.1. The reliability of the predicted components and targets was verified using Pymol 1.7.2.1 and Autodock Vina 1.1.2 reverse molecular docking. Results: A total of 262 unique active components and 680 potential active targets of E-Lian granule were obtained. Moreover, 2247 unique disease targets of chronic atrophic gastritis with intestinal metaplasia were obtained by searching the “Disease/Symptom Target Database” combined with the GEO chip (GSE78523) and GeneCard database. Further, 178 complex targets and 38 complex core targets were obtained using Venn and Filter, respectively, such as ALB, TNF, PTGS2, RHOA, ESR1, HRAS, JUN, FOS, CASP3 and so forth. The GO and KEGG nrichment analyses showed that E-Lian granule reversed gastric precancerous lesions not only through the direct intervention of the cancer pathway, gastric cancer pathway, and epithelial signal transduction in Helicobacter pylori infection but also through PI3K/AKT, VEGF, MAPK, cAMP, cGMP, Th1/Th2,and other pathways. It also had a significant correlation with cholinergic, 5-hydroxytryptamine, dopaminergic, and other gastrointestinal hormone-related signals. Finally, the core target verified in the GSE78523 chip was successfully used to dock with the active components of E-Lian granules. The reliability of the prediction was also verified. Conclusions: The components and molecular mechanism of E-Lian granule in reversing chronic atrophic gastritis with intestinal metaplasia were predicted by integrated pharmacology, GEO chip, and reverse molecular docking, providing an important theoretical basis for further study of the effective substances and mechanism of E-Lian granule in treating chronic atrophic gastritis.

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