ETHNOPHARMACOLOGICAL RELEVANCE:Xiangsu Hewei Granules are an herbal preparation that has shown potential for controlling symptoms of nonerosive gastroesophageal reflux disease (NERD) in preliminary studies. However, high-quality randomized controlled evidence for its use in NERD remains lacking. AIM:To verify the efficacy and safety of Xiangsu Hewei Granules in treating NERD with liver stomach stagnation heat syndrome. MATERIALS AND METHODS:This randomized, double-blind, placebo-controlled, multicentre phase III trial included 480 patients (aged 18-65 years) with confirmed NERD (GerdQ≥8; negative H. pylori) and traditional Chinese medicine (TCM) liver stomach stagnation heat syndrome. Patients were randomized 3:1 to receive either Xiangsu Hewei Granules or placebo, thrice daily for 8 weeks. The primary outcomes were the effective rate of the response based on visual analog scale (VAS) scores for heartburn and acid regurgitation at week 8. The secondary outcomes included reductions in the TCM syndrome score, etc. RESULTS: 479 participants (mean age 48.5 years, SD10.2; 54.3% female) entered the full analysis set and safety set (360 tests group; 119 control group, 1 participant in the control group withdrawing before medication). At week 8, compared with the control group, the test group demonstrated significantly better effective rate of VAS score response for heartburn(76.39% vs 21.01%, 95% CI 55.38 (45.98, 62.94) %, p < 0.01),acid regurgitation (79.72% vs 23.53%, 95% CI56.39 (46.90, 64.12) %, p < 0.01), and TCM syndrome score (69.23% vs 30.13%, p < 0.01) at week 8. CONCLUSION:In this selected population of NERD patients with liver-stomach stagnation heat syndrome (e.g., negative H. pylori, no pH-impedance phenotype, and low anxiety/depression scores), Xiangsu Hewei Granules demonstrated efficacy and safety in improving heartburn, acid regurgitation, and TCM syndrome scores. However, generalizability to the broader NERD population and its comparative effectiveness against standard proton pump inhibitor therapy require further investigation.
Cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) exists not only as a membrane-bound immune checkpoint but also as a naturally secreted soluble isoform (sCTLA-4), generated primarily through exon 3 skipping. This review focuses specifically on splice-derived sCTLA-4 and examines its biological and clinical significance. sCTLA-4 is shaped by immune state, cellular source, and tissue microenvironment. Mechanistically, sCTLA-4 can restrain B7/CD28-dependent immune activation, while recent preclinical evidence suggests a preferential effect on type 1 immune responses. In autoimmune and inflammatory diseases, longitudinal changes in sCTLA-4 often parallel changes in immune activity, although its performance as a disease-specific biomarker remains limited. In cancer, associations with tumor burden, prognosis, and treatment response are more variable and appear to depend strongly on the surrounding immune context. Thus, circulating sCTLA-4 may be better viewed as a state-dependent immunoregulatory signal than as a universal standalone biomarker. Current evidence does not clearly establish whether its elevation is causal, compensatory, or epiphenomenal. Key translational priorities include detection methods that distinguish sCTLA-4 isoforms and cellular sources, standardized longitudinal sampling, biomarker panels that integrate sCTLA-4 with defined immune phenotypes, and therapeutic strategies tailored to specific immune contexts while preserving peripheral tolerance.
The functional application of sea buckthorn (SB) juice is often limited by poor extractability and bioavailability of polysaccharides and phenolic compounds, as well as inadequate processing strategies to improve their recovery and functional activity. This study employed an integrated bioprocess that combines enzyme-assisted extraction (EAE), lactic acid bacteria (LAB) fermentation, and botanical dietary fiber supplementation (DF) to improve the functional and nutraceutical properties of SB juice. Response surface methodology (RSM) was used to optimize EAE for maximal polysaccharide yield, and the optimized SB extract was fermented using a mixed culture of two LAB strains (LZ122 and QA52) at an optimized 1:3 (v/v) ratio, either in the absence or presence of DF. Fermentation supported LAB growth, with viable cell counts increasing to approximately 8 log CFU/mL after 24 h of incubation. Fermentation substantially improved the inhibitory activities against α-glucosidase and α-glucoamylase, with the highest enhancement observed during DF supplementation prior to fermentation. In addition, fermented sea buckthorn (FSB) samples showed enhanced antibacterial activity against Escherichia coli and Staphylococcus aureus. Untargeted LC-MS metabolomic analysis (SB vs FSB) revealed fermentation-associated remodeling of the SB metabolome, characterized by increased abundances of flavonoids (e.g., rutin, quercetin glycosides, and daidzein) and organic acids, which are consistent with the enhanced enzyme inhibitory and antibacterial activities observed. Collectively, these results demonstrate that RSM-optimized EAE for polysaccharide recovery combined with LAB fermentation and DF supplementation significantly enhances the functional potential of SB juice, supporting its potential application in functional food development with in vitro inhibitory activity against carbohydrate-digestive enzymes. Further mechanistic research and in vivo validation are warranted.
INTRODUCTION:Epidemiological studies link helminth infections to reduced obesity prevalence, but the mechanisms remain incompletely understood. OBJECTIVES:To determine whether and how Heligomosomoides polygyrus (H. polygyrus) infection impairs dietary fat absorption in fat mice. METHODS:H. polygyrus- infected wild-type (WT) and STAT6 knockout (KO) mice were used to assess the role of STAT6 in helminth-induced lipid metabolism changes. Complementary in vitro experiments were performed using cytokine-treated Caco-2 cells, and single-cell RNA sequencing (scRNA-seq) was conducted on intestinal epithelial cells (IECs) to further explore underlying molecular mechanisms. RESULTS:We demonstrated that H. polygyrus infection impaired dietary fat absorption in mice via STAT6-dependent suppression of microsomal triglyceride transfer protein (MTTP), a key mediator of chylomicron assembly. WT mice infected with H. polygyrus exhibited increased fecal lipid excretion, reduced serum triglycerides, and enterocyte lipid retention, phenotypes absent in STAT6 KO mice. In vitro, IL4/IL13 treatment of polarized Caco-2 cells suppressed MTTP expression and lipid export, mirroring in vivo findings. Single-cell RNA sequencing of IECs revealed STAT6-dependent downregulation of lipid metabolism pathways and upregulation of immune responses. CONCLUSION:These results identify a metabolic-immune trade-off in which helminth-induced Type 2 cytokines prioritize host defense over nutrient absorption, attenuating obesity, highlighting MTTP as a novel therapeutic target for metabolic disorders and underscores the role of helminth immunomodulation in systemic energy homeostasis.
Ulcerative colitis (UC) is a chronic and recurrent inflammatory intestinal disorder characterized by gut dysbiosis, but effective strategies are currently limited. Here, we demonstrated that Agrimoniae Herba Polysaccharides (AHP), the key active components of a herb widely used for intestinal inflammation in East Asia countries, significantly reversed colitis-related phenotypes in a gut microbiota dependent, as antibiotic treatment abolished its therapeutic effect, while gut microbes from AHP-treated mice reproduced the anti-inflammatory effect. Bacterial 16S rRNA sequencing analysis showed AHP greatly reshaped the overall structure of microbiota, especially boosting colonization of Faecalibaculum rodentium (F. rodentium), which led to a significant alleviation of intestinal inflammation, accompanied by the promotion of CD4+ T cell differentiation toward Treg. Additionally, we identified quinic acid as a key metabolite of F. rodentium enriched by AHP treatment, and found that it induced the differentiation of naïve CD4+T cells sorted from UC patients into Treg cells in vitro, which correlated with the enhancement of TAZ/Foxp3 acetylation axis. Collectively, our results show that AHP exerts the beneficial effects in the treatment of UC by acting as a prebiotic to enrich the commensal bacterium F. rodentium, and offer a novel microbiota-dependent strategy for inflammatory bowel disease.
[This corrects the article DOI: 10.3892/etm.2017.5076.].
Objective:To investigate the anti-inflammatory mechanisms of Hudi enteric-coated capsule (HDEC) and its major bioactive constituent, polydatin, in ulcerative colitis (UC). Methods:Mouse models of colitis were established by transplantation adoptive transfer of CD45RBhighCD4+ T cells and treated with or without HDEC/polydatin. Therapeutic efficacy was evaluated by assessing disease activity, colon length, and histopathological damage. The differentiation of Th1, Th17, and Treg cells was analyzed using quantitative real-time polymerase chain reaction and flow cytometry. In vitro cultures of mouse and human CD4+ T cells were utilized to assess the immunomodulatory activity. RNA sequencing, Western blotting, and immunofluorescence were used to explore the underlying mechanism. Molecular docking, molecular dynamics, and surface plasmon resonance (SPR) assays were employed to confirm the interaction between polydatin and KEAP1. Results:Treatment with HDEC and polydatin significantly ameliorated murine colitis and mucosal damage. Mechanistically, polydatin directly binds to KEAP1 to promote NFE2L2 nuclear translocation. This NFE2L2 activation reduces intracellular oxidative stress, thereby inhibiting pathogenic Th1/Th17 differentiation and enhancing Treg generation. Importantly, these effects were consistently validated in human CD4+ T cells and UC mucosal tissues. Conclusion:HDEC and polydatin alleviate UC by targeting the KEAP1-NFE2L2 axis to reduce oxidative stress, thereby restoring the Th1/Th17/Treg balance. This highlights polydatin as a promising KEAP1-targeting agent with strong translational potential.
Nonalcoholic fatty liver disease (NAFLD) is a growing health burden worldwide. The association between blood selenium (Se) and NAFLD in naturally menopausal women remains unclear. This study aimed to evaluate the association of blood Se levels with the prevalence of NAFLD, hepatic steatosis, and liver fibrosis in the US naturally menopausal women population. This study analyzed the dataset from the 2017 to 2018 National Health and Nutrition Examination Survey, including 595 naturally menopausal women. Weighted logistic regression models were used to evaluate the cross-sectional association between blood Se levels and the prevalence of NAFLD. Linear regression and ordinal logistic regression were used to evaluate the association between blood Se levels and liver steatosis and fibrosis. All analyses were conducted using the R survey package. There were no significant associations of blood Se levels with NAFLD in 3 adjusted models (odds ratio [OR] = 0.52, 95% confidence interval [CI], 0.04-7.11; OR = 0.66, 95% CI, 0.04-9.82; OR = 0.79, 95% CI, 0.08-8.08). However, in the fully adjusted model, blood Se levels showed a negative association with liver fibrosis (β = -2.32, 95% CI, -4.21, -0.43). Participants were divided into quartiles (Q1-Q4) based on the distribution of blood Se concentrations within the study cohort. The specific cutoff points were Q1 group (<173.67 μg/L), Q2 group (173.67 to <189.15 μg/L), Q3 group (189.15 to <204.35 μg/L), and Q4 group (≥204.35 μg/L). Compared with the reference group (Q1 group, <173.67 μg/L), significant inverse associations were also found for the higher Se groups (Q3 group: OR = 0.23, 95% CI, 0.1-0.53; Q4 group: OR = 0.28, 95% CI, 0.12-0.66). Our results showed that blood Se levels were not significantly associated with the prevalence of NAFLD in a US population of naturally menopausal women, but higher blood Se levels were negatively associated with liver fibrosis. Further research is needed to assess the causal relationship between exposure and disease risk.
ABSTRACT Gut microbiota has become a key therapeutic target for inflammatory bowel disease (IBD). Astragalus polysaccharides (AP), the main active components of Astragalus membranaceus, can prevent experimental colitis, but their mechanisms remain unclear. This study investigated the therapeutic effect of AP on DSS‐induced colitis and its mechanism of attenuation. AP significantly improved colitis by increasing body weight and colon length, reducing histological injury, and lowering the disease activity index (DAI). AP inhibited proinflammatory cytokines (IL‐6, IL‐17A, IL‐22, IL‐23), upregulated anti‐inflammatory cytokines (IL‐10, TGF‐β) in colon tissue, and increased fecal SCFA levels. AP also reshaped gut microbiota by decreasing Proteobacteria, Verrucomicrobia, Allobaculum, Turicibacter, and Akkermansia, while enriching Firmicutes, Bacteroidetes, Lactobacillus, Lachnospiraceae, Ruminococcus, and Oscillospira. These enriched genera positively correlated with IL‐10, TGF‐β, and SCFAs, and negatively with IL‐6, IL‐17A, and IL‐23. KEGG analysis showed that AP restored metabolic pathways disrupted during colitis. Overall, AP protected against DSS‐induced colitis by modulating gut microbial composition, metabolism, and immune responses. Importantly, ABX + AP experiments confirmed that the therapeutic effect of AP depends on gut microbiota. These findings indicate that AP alleviates colitis by remodeling the gut microbiota and may serve as a promising microbiome‐based therapy for ulcerative colitis.
Ethnopharmacological relevance The Hewei Jiangni Prescription (HP) is a traditional Chinese prescription, which has shown clinical benefits for many years in non-erosive reflux disease (NERD)-associated esophageal hypersensitivity. However, its mechanism of effects remains unclear. Aim of the study To investigate the mechanism of HP in treating NERD-associated esophageal hypersensitivity and identify its pharmacologically active components. Materials and methods NERD-associated esophageal hypersensitivity model mice were treated with HP. Proteomics and protein interaction networks were employed to identify differentially regulated targets. Effects on key targets were validated in cell models and model mice using enzyme-linked immunosorbent assay, western blotting, reverse transcription‒quantitative polymerase chain reaction, and immunofluorescence. Bio-layer interference technology was used to identify HP components binding to targets, followed by liquid chromatography‒mass spectrometry identification and functional validation in cell models. Results HP mitigated esophageal pathology and visceral hypersensitivity in NERD-associated esophageal hypersensitivity model mice. Additionally, HP may attenuate neuroimmune dysregulation in the experimental model by downregulating MrgprX2/B2 overexpression in mast cells and dorsal root ganglion (DRG) neurons, lowering intracellular Ca2+ levels, and decreasing the release of mast cell tryptase and calcitonin gene-related peptide. Vitexin was identified as one of the bioactive components of HP, reproducing its core pharmacological effects in vitro and exhibiting high affinity for the MRGX2 target. Conclusions This study suggests that HP may attenuate neuroimmune dysregulation between mast cells and DRG neurons by regulating MrgprX2/B2, thereby mitigating NERD-associated esophageal hypersensitivity. Additionally, the study findings suggest that vitexin may be one of the bioactive components of HP.
BACKGROUND:Traditional Chinese medicines, as a burgeoning field of medication, significantly alleviate ulcerative colitis (UC) by improving intestinal microbiota-metabolism. Our previous studies demonstrated the significant efficacy of Hudi Enteric-coated capsules (HDEC), Qingchang Wenzhong decoction (QCWZ), and Modified Wumei pill (MWMP) using a mouse model of colitis. However, the mechanism of these therapies through the modulation of microbiota-metabolism remains uncertain. OBJECTIVE:Three multicenter randomized controlled trials were designed to explore the effects of three therapies on the microbiota-metabolism of UC patients with different severity. METHODS:A total of 143 patients with different severities of UC were recruited from 10 hospitals. The clinical efficacy of HDEC for mild UC, QCWZ for moderate UC, and MWMP for severe UC (SUCs) was evaluated by colorectal Mayo scores and systemic inflammatory indicators. The 16S rRNA sequencing and metabolomics were used to analyze intestinal microbiota and metabolite profiles. RESULTS:Three therapies used alone or combined with mesalazine (MS) were comparable to MS alone in improving Mayo scores and hematic inflammatory parameters. Microbial diversities and architectures of SUCs showed the greatest response to MWMP+MS than other medications, as reflected by the enriched Ruminococcus and Anaerostipes together with the reduced Enterococcus, Streptococcus, and Streptococcus anginosus. Furthermore, MWMP+MS boosted the production of the microbiota-derived short-chain fatty acids (SCFAs) of SUCs. These differential microbes and metabolites further displayed significant statistical relationships with clinical parameters. CONCLUSION:Herbal therapies, especially MWMP+MS, effectively improve microbiota composition and SCFA metabolism, which correlates with the improvements of serum inflammatory markers and endoscopic findings in patients.
Inflammatory bowel disease (IBD) is a chronic recurrent IBD, whose cause involves the interaction between genetic and environmental factors. Although there is a recognized link between immune response and IBD, the causal relationship between circulating immune cell counts and IBD remains controversial. This study aimed to elucidate the causal relationship between genetically predicted circulating immune cell counts and IBD. We conducted a bidirectional 2-sample Mendelian randomization (MR) study using aggregated statistics from genome-wide association studies. The causal relationship between 5 circulating leukocytes cells (monocytes, lymphocytes, eosinophils, basophils and neutrophils) counts and IBD, including ulcerative colitis (UC) and Crohn disease (CD) was analyzed. Horizontal pleiotropy test and heterogeneity test were used to ensure the stability of the results. Our findings indicated that monocytes, lymphocytes, eosinophils, and basophils count were not significantly associated with IBD, however, elevated circulating neutrophils count was significantly associated with higher risk of IBD [odds ratio (OR) = 1.0017; 95% confidence interval (CI) = 1.0004–1.003; P = .009] and UC [OR = 2.465; 95% CI = 1.236–4.916; P = .01]. In addition, we also found that IBD [OR: 12.07; 95% CI = 1.909–76.316; P = .008] and CD [OR = 1.014; 95% CI = 1.004–1.023; P = .005] were significantly associated with higher circulating neutrophils count in reverse MR. This MR study provides genetic evidence for the causal relationship between the genetically predicted increase in circulating neutrophils count and the risk of IBD (UC and CD). This finding stresses the need for further exploring physiological functions of neutrophils in order to develop effective strategies against IBD.
Updates to the modern diagnosis of GERD: Lyon consensus 2.0 was published online in September 2023. It presents 23 consensus statements that update the modern definition of gastro-esophageal reflux disease (GERD) and optimize the diagnosis and management of GERD, providing an up-to-date basis for the diagnosis and treatment of GERD. The international consensus is based on the evaluation of studies conducted since the original consensus was published. However, due to the limitations of evidence-based evidence and the differences in national conditions, populations, and economic levels of different countries, it is necessary to interpret its applicability in China, so as to better promote the dissemination of its content and its implementation, and provide patients with the most appropriate guidance for clinical practice.
Microbial fermentation is a promising strategy to enhance the efficacy and functional properties of herbs. A traditional Chinese medicine formula, known as the Qihuang Biwen decoction (QHBW), has been shown to have immunomodulatory benefits in clinical and experimental studies. Nevertheless, few studies have investigated the effects of microbial-fermented QHBW (FQHBW) on immunity. In this study, we used one-way and Plackett-Burman analyses to establish the preparation process of FQHBW (crucial parameters: ratio of bacterial strains LZU-J-TSL6 and LZU-S-ZCJ was 3:1, inoculum quantity was 3
Aim:Our research aimed to investigate the relationship between the systemic immune-inflammatory index (SII) and the immunological response to hepatitis B vaccination. Methods:We collected data from the National Health and Nutrition Examination Survey database from 2007 to 2018. To examine the association between the SII and immunological response, we conducted weighted multiple regression analysis and subgroup analysis. Furthermore, we utilized restricted cubic splines (RCSs) to analyze the linear relationship between the two variables. Results:In our study, we included a total of 6,123 patients, of whom 2,770 tested positive for hepatitis B antibodies. Multivariate logistic regression analysis indicated that, after controlling for all measured factors, a high level of the SII was inversely associated with the presence of antibodies following three doses of the hepatitis B vaccine (OR = 0.8661, 95% CI = 0.7577-0.9899, p = 0.035). Subgroup analysis and interaction testing revealed that sex, age, body mass index, diabetes, and other factors did not significantly influence this negative association (P for interaction >0.05). Additionally, the RCS model revealed no non-linear relationship between the SII and the immune response to the hepatitis B vaccine (p > 0.05). Notably, antibody expression significantly decreased as the SII increased beyond the threshold of 448.3. Conclusion:This cross-sectional study revealed a strong association between low antibody production following hepatitis B vaccination and the SII. However, this cross-sectional study could not establish a causal relationship between the two variables. Therefore, further experimental verification is necessary to confirm the correlation observed in our study.
Functional dyspepsia (FD), characterized by persistent or recurrent dyspeptic symptoms without identifiable organic, systemic or metabolic causes, is an increasingly recognized global health issue. The objective of this guideline is to equip clinicians and nursing professionals with evidence-based strategies for the management and treatment of adult patients with FD using traditional Chinese medicine (TCM). The Guideline Development Group consulted existing TCM consensus documents on FD and convened a panel of 35 clinicians to generate initial clinical queries. To address these queries, a systematic literature search was conducted across PubMed, EMBASE, the Cochrane Library, China National Knowledge Infrastructure (CNKI), VIP Database, China Biology Medicine (SinoMed) Database, Wanfang Database, Traditional Medicine Research Data Expanded (TMRDE), and the Traditional Chinese Medical Literature Analysis and Retrieval System (TCMLARS). The evidence from the literature was critically appraised using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. The strength of the recommendations was ascertained through a consensus-building process involving TCM and allopathic medicine experts, methodologists, pharmacologists, nursing specialists, and health economists, leveraging their collective expertise and empirical knowledge. The guideline comprises a total of 43 evidence-informed recommendations that span a range of clinical aspects, including the pathogenesis according to TCM, diagnostic approaches, therapeutic interventions, efficacy assessments, and prognostic considerations. Please cite this article as: Zhang SS, Zhao LQ, Hou XH, Bian ZX, Zheng JH, Tian HH, Yang GH, Hong WS, He YY, Liu L, Shen H, Li YP, Xie S, Shu J, Zeng BF, Li JX, Liu Z, Xiao ZH, Xiao JD, Zheng PY, Huang SG, Chen SL, Fei GJ. International clinical practice guideline on the use of traditional Chinese medicine for functional dyspepsia (2025). J Integr Med. 2025; 23(5):502-518.
ETHNOPHARMACOLOGICAL RELEVANCE:Hemerocallis citrina Baroni (H. citrina), referred to as 'Forgetting Sadness Grass,' is a traditional Chinese medicine (TCM) known for its antidepressant effects. Fermentation is an ancient processing method for TCM. Whether fermentation affects the antidepressant effect of H. citrina is unknown. AIM:In this study, we aim to evaluate the effect of fermented and unfermented H. citrina on chronic restraint stress-induced depression and the underlying mechanism. MATERIALS AND METHODS:H. citrina was co-fermented with Lactiplantibacillus plantarum strains LZU-J-TSL-6 and LZU-J-LZ1-1 to produce fermented H. citrina (FH). Both H. citrina and FH were evaluated for effects on depression and anxiety in chronic restraint stress (CRS) mice. RESULTS:Fermentation increased flavonoids and phenols while reducing terpenoids. Both H. citrina and FH exhibited antidepressant effects, with FH showing superior efficacy in alleviating depressive symptoms. Specifically, FH effectively alleviated weight loss, behavioral abnormalities, and hippocampal pathological damage caused by CRS, while significantly reducing serum levels of cortisol and inflammatory factors, and increasing hippocampal serotonin (5-HT) level. Moreover, FH can restore CRS-induced gut microbiota dysbiosis by promoting the colonization of beneficial microbes, such as Lactobacillus, and inhibiting the growth of harmful microbes, like Bacteroides_H. Importantly, we discovered that the antidepressant effects of FH are closely associated with substances such as L-theanine and myo-inositol, as well as with the metabolic pathways of alanine, aspartic acid, and glutamic acid. CONCLUSION:Our findings suggest that fermentation alters the composition of active ingredients in H. citrina and enhance its role in depression. It highlights the potential therapeutic application of FH in treating depression.
Background:Mesalazine preparations serve as first-line therapy for active mild-to-moderate ulcerative colitis(UC),however,not all patients respond to mesalazine.Patients with mesalazine-refractory UC often switch to corticosteroids,immunological therapy,and biological agents,but their use is limited owing to their well-characterised side effects(e.g.osteoporosis and cushingoid feature).Therefore,there is an unmet medical need for novel treatments with a manageable safety profile for patients with mesalazine-refractory UC.New Wumei Pill is a novel and effective herbal prescription for the treatment of UC,and our preliminary study suggested that New Wumei Pill has a significant effect on patients with mesalazine-refractory UC.However,its effectiveness and safety has not been evaluated convincingly. Objectives:This trail aims to evaluate efficacy,safety and mechanisms of New Wumei Pill in the treatment of patients with mesalazine-refractory UC. Methods:This is a prospective,randomized,double-blind control trial,in which 72 patients with mesalazine-refractory mild-to-moderate UC will be randomized in a 1:1 ratio in the treatment and control group.Patients will be screened for eligibility at the outpatient and ward of the Department of Gastroenterology in Dongfang Hospital,Beijing University of Chinese Medicine.72 participants will undergo strict screening to meet the diagnostic criteria of mildly to moderately active UC,with modified Mayo score of 3-10 points.All patients will be administered by mesalazine enteric-coated tablets for 8 weeks,at the same time,the patients in treatment group will receive New Wumei Pill,while patients from control group will be administered by dummy New Wumei Pill. Results:The primary outcomes are clinical efficacy rate and clinical remission rate according to the modified Mayo score.The secondary outcomes are individual symptom score,TCM syndrome score,endoscopic response rate,mucosal healing rate,and quality of life scale score.Finally,biological samples from participants will be preserved to reveal the mechanisms of New Wumei Pill on UC. Conclusions:We hypothesize that the patients with mesalazine-refractory mild-to-moderate UC will benefit from New Wumei Pill.If successful,this trial will provide evidence of traditional Chinese medicine in the treatment of UC,and hold promises for novel options UC patients and policymakers.