[Translation] A randomized, double-blind, placebo-controlled, multicenter phase III clinical trial on the efficacy and safety of Shenqi Sherong Pills in the treatment of mild and moderate cervical spondylotic myelopathy (Qi deficiency, blood stasis, and kidney deficiency syndrome)

以安慰剂为对照，验证参芪麝蓉丸治疗轻、中度脊髓型颈椎病（气虚血瘀肾亏证）的有效性和安全性，为申请药品上市提供依据

[Translation]

Using placebo as control, verify the effectiveness and safety of Shenqi Sherong Pills in treating mild and moderate cervical spondylotic myelopathy (Qi deficiency, blood stasis, and kidney deficiency syndrome), and provide a basis for applying for drug marketing

Start Date10 May 2024

Sponsor / Collaborator

Longhua Hospital Shanghai University of TCM

[+1]

ChiCTR2400081162 / SuspendedNot ApplicableIIT

Traditional Chinese Medicine based on the academic experience of Ganren Ding for Parkinson's Disease: a multicentre, randomized, controlled, double-blind trial

Start Date01 Mar 2024

Sponsor / Collaborator

Longhua Hospital Shanghai University of TCM

NCT05773716 / RecruitingNot ApplicableIIT

The Effects of Combination Therapy With Electroacupuncture and Pelvic Floor Muscle Training on Stress Urinary Incontinence Following Radical Prostatectomy: A Randomized Controlled Trial

The goal of this clinical study is to compare the effects of combined electroacupuncture with pelvic floor muscle training (PFMT) versus PFMT alone in the treatment of involuntary urine leakage following prostate removal procedure due to prostate cancer. The main question it aims to answer is that whether adding electroacupuncture to PFMT provides extra benefits in relieve urinary leakage and improves patients' quality of life. All participants will be required to perform daily PFMT for 6 weeks using uniformed standards. During the meantime, those assigned to the experimental group will additionally receive electroacupuncture three times per week for 6 weeks, while those in control group will receive sham treatment with same duration. Researchers will compare the urine leakage severity between the two groups to see if adding electroacupuncture can facilitate the recovery of symptom.

Start Date01 Dec 2023

Sponsor / Collaborator

Longhua Hospital Shanghai University of TCM

100 Clinical Results associated with Longhua Hospital Shanghai University of TCM

0 Patents (Medical) associated with Longhua Hospital Shanghai University of TCM

103

Literatures (Medical) associated with Longhua Hospital Shanghai University of TCM

31 Dec 2024·Renal Failure

Exercise training and chronic kidney disease: characterization and bibliometrics of citation classics of clinical intervention trials

Article

Author: Zhang, Fan ; Huang, Liuyan ; Li, Yi ; Bai, Yan ; Liu, Shan ; Zhong, Yifei

BACKGROUNDExercise research targeting chronic kidney disease (CKD) has been conducted for more than 30 years, and the benefits of exercise for CKD patients have been progressively demonstrated. This study analyzes citation classics on clinical intervention trials on exercise training and CKD to describe the research landscape and hotspots through bibliometric analysis.METHODSTo identify clinical trials of exercise training interventions for CKD with more than 100 citations from the Web of Science Core Collection database. Extracted bibliometric information, participant information, and study characteristics of the included articles. The total citations, annual average citations, publication of year, author keywords, and study-related data were bibliometric analyzed and described using Excel 2019 and VOSviewer software.RESULTSA total of 30 citation classics were included, with a total citation frequency of 102 to 279 (mean ± standard deviation: 148.4 ± 49.4). The American Journal of Kidney Diseases (n = 7) published the most (n = 7) classic citations in the field of CKD exercise research, and the Journal of the American Society of Nephrology was the most cited. The hotspot of research around CKD and exercise training interventions focused on population (hemodialysis and end-stage renal disease), exercise type (resistance training, yoga, and leg-cycling), and outcomes (cardiovascular indices, physical performance, psychological status, kidney function, physical activity). Reported dropout rates ranged from 0.0% to 47.4%.CONCLUSIONA bibliometric analysis of citation classics on exercise training and CKD highlights the potential benefits of exercise as a non-pharmacological therapy for patients with CKD, as well as developments and hotspots in the field.

01 Nov 2024·Gut

Pancreatic STAT5 activation promotes Kras ^G12D -induced and inflammation-induced acinar-to-ductal metaplasia and pancreatic cancer

Article

Author: Guo, Yangyang ; Feng, Wenxue ; Lin, Yuli ; Xia, Qing ; Liu, Liang ; Wan, Yaqi ; Yang, Xuguang ; Ying, Ying ; Ma, Shuai ; Meng, Xiang Jun ; Wang, Jun ; Wu, Zhihao ; Pu, Shaofeng ; Wang, Wenquan

ObjectivePancreatic ductal adenocarcinoma (PDAC) is a highly lethal malignancy because it is often diagnosed at a late-stage. Signal transducer and activator of transcription 5 (STAT5) is a transcription factor implicated in the progression of various cancer types. However, its role in KRAS-driven pancreatic tumourigenesis remains unclear.Design We performed studies with LSL-KrasG12D ; Ptf1a-CreERT (KC ERT ) mice or LSL-Kras G12D ; LSL-Trp53 R172H ; Pdx1-Cre (KPC) mice crossed with conditional disruption of STAT5 or completed deficiency interleukin (IL)-22. Pancreatitis was induced in mice by administration of cerulein. Pharmacological inhibition of STAT5 on PDAC prevention was studied in the orthotopic transplantation and patient-derived xenografts PDAC model, and KPC mice. ResultsThe expression and phosphorylation of STAT5 were higher in human PDAC samples than control samples and high levels of STAT5 in tumour cells were associated with a poorer prognosis. The loss of STAT5 in pancreatic cells substantially reduces the KRAS mutation and pancreatitis-derived acinar-to-ductal metaplasia (ADM) and PDAC lesions. Mechanistically, we discovered that STAT5 binds directly to the promoters of ADM mediators, hepatocyte nuclear factor (HNF) 1β and HNF4α. Furthermore, STAT5 plays a crucial role in maintaining energy metabolism in tumour cells during PDAC progression. IL-22 signalling induced by chronic inflammation enhances KRAS-mutant-mediated STAT5 phosphorylation. Deficiency of IL-22 signalling slowed the progression of PDAC and ablated STAT5 activation.ConclusionCollectively, our findings identified pancreatic STAT5 activation as a key downstream effector of oncogenic KRAS signalling that is critical for ADM initiation and PDAC progression, highlighting its potential therapeutic vulnerability.

01 Oct 2024·Contemporary Clinical Trials Communications

Safety and efficacy of traditional Chinese manual therapy for cervicogenic dizziness: study protocol for a randomized, controlled, multicenter trial

Article

Author: Ning, Jiawei ; Zhang, Yujie ; Yuan, Weian ; Chai, Yongli ; Kong, Lingjun ; Zhao, Ye ; Zhan, Yunfan ; Liu, Kaoqiang

BackgroundCervicogenic dizziness is a clinical syndrome characterized by neck pain and dizziness, which has a rising incidence in recent years. In China, manual therapy has been widely used in the treatment of cervicogenic dizziness, but there is no high-quality medical evidence to support its effectiveness and safety. The purpose of this study was to assess the safety and efficacy of Shi's manual therapy (SMT) on the treatment of cervicogenic dizziness.MethodsA multicenter randomized controlled trial (RCT) will perform on 106 patients (18≤ages≤65) who meet the diagnostic criteria of cervicogenic dizziness. Patients will be randomly allocated to the intervention group and the control group at a ratio of 1:1. Participants in the control group will be treated with Merislon (Betahistine Mesilate Tablets). Participants in the intervention group will be treated with SMT. The primary outcome is the response rate at week 2, which is defined as the proportion of patients who reduce their disability level measured by the Dizziness Handicap Inventory (DHI) score relative to baseline. Key secondary outcomes include DHI scores at weeks 1, 2, and 6 and changes from baseline, time to disappearance of dizziness symptoms, and recurrence rate of dizziness symptoms. Safety will be assessed by adverse events, physical examination and vital signs.DiscussionThis trial aims to provide high-quality evidence-based medical data to demonstrate that SMT can reduce dizziness in patients with cervicogenic dizziness effectively and safely.Trial registrationClinical Trial Registration Center NCT05604937. Registered on Nov 3, 2022.Protocol version1.0, November 20, 2022.

100 Deals associated with Longhua Hospital Shanghai University of TCM

100 Translational Medicine associated with Longhua Hospital Shanghai University of TCM

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The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Preclinical

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Shenqi Sherong Pills	Cervical myelopathy More	Phase 3
Fuhuang Tablets	Hemorrhoids More	Phase 2
Shuanghuang Shengbai Oral Liquid	Neutropenia More	Phase 2
Arctigenin ( ADIPOR1 x PP2A )	Diabetic Nephropathies More	Preclinical

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