Clinical trials

The goal of this clinical trial is to learn if electroacupuncture can improve sleep in people with chronic sciatica caused by lumbar disc herniation. It will also assess the safety of this treatment. The main questions it aims to answer are whether electroacupuncture improves sleep quality and whether it reduces pain and improves daily function. Researchers will compare electroacupuncture to a sham treatment, which looks like real acupuncture but has little or no therapeutic effect, to determine its effectiveness. Participants will be randomly assigned to receive electroacupuncture or sham treatment, will receive treatment three times per week for four weeks, and will complete questionnaires about their sleep, pain, and daily activities.

With the agarose concentrating group of Peiyuan Guben Tongluo Ointment set as the parallel control and an external control established simultaneously, this study aimed to evaluate the increases from baseline in DXA-measured limb muscle mass after 12 weeks of medication in elderly sarcopenia patients treated with the Ejiao concentrating group of Peiyuan Guben Tongluo Ointment.

This study is a cross-sectional, observational investigation designed to develop and validate a noninvasive ocular imaging-based predictive model for major inflammatory skin diseases, including psoriasis, atopic dermatitis, and urticaria. Grounded in Traditional Chinese Medicine (TCM) ocular diagnostic theory and integrated with advanced computer vision techniques, the study aims to establish objective, quantifiable biomarkers derived from scleral and bulbar conjunctival images. Approximately 950 participants (patients with psoriasis, atopic dermatitis, urticaria, and healthy controls) will be recruited from a tertiary academic hospital. Standardized high-resolution ocular images will be collected alongside comprehensive clinical, demographic, and comorbidity data. Disease severity will be assessed using validated clinical scoring systems (e.g., PASI, EASI, UAS7, DLQI). Image analysis will combine traditional radiomics feature extraction with deep learning architectures, including a Vision State-Space (VMamba) module for global-local feature representation and a Multi-Gate Mixture-of-Experts (MMoE) framework for multi-task learning. The model is designed to simultaneously perform disease classification and predict comorbidity risks (such as metabolic syndrome, hepatic insulin resistance, and recurrence risk). Primary outcomes include characterization of ocular feature patterns associated with inflammatory skin diseases. Secondary outcomes include correlations between ocular image-derived features and clinical severity indices. Model performance will be evaluated using ROC curves, AUC, calibration analysis, and decision curve analysis. This study aims to provide an objective, digitalized, and clinically applicable ocular biomarker framework to support early diagnosis, risk stratification, and comorbidity screening in inflammatory skin diseases.

Psoriasis Vulgaris is a chronic, inflammatory, and immune-activated skin disease. It is the most common type of psoriasis, accounting for approximately 85-90% of all psoriasis patients. Its clinical features include erythema, papules, covered with varying scales, a long course of disease, and recurrent attacks. According to traditional Chinese medicine, psoriasis is mainly characterized by blood heat syndrome, blood stasis syndrome and blood dryness syndrome, accounting for more than 90% of all syndrome types. The TCM syndrome differentiation and treatment of psoriasis also attach great importance to the transformation and evolution of TCM syndrome types. For instance, the three syndrome types of blood heat syndrome, blood stasis syndrome and blood dryness syndrome are not static and can transform into each other. For example, blood heat syndrome can develop into blood dryness syndrome as the disease progresses, blood dryness syndrome can transform into blood stasis syndrome, and blood stasis syndrome can also transform into blood heat syndrome or blood dryness syndrome. Observation is an important diagnostic method in traditional Chinese medicine. The images of tongue and face diagnosis contain a lot of important clinical information. They can objectively reflect the prosperity and decline of qi and blood in the human body, the nature of diseases, the depth of the lesion location, the prognosis of the disease, and can also reflect the physiological and pathological changes of the body. In recent years, significant progress has been made in the research of digital and intelligent technologies for tongue and facial diagnosis. Introducing objective indicators such as tongue diagnosis, facial diagnosis and pulse diagnosis into the evaluation research of diseases has become a hot topic. This project, by analyzing the clinical tongue and facial image data of patients with psoriasis vulgaris and combining it with clinical laboratory indicators, fuses and analyzes the characteristic parameters of patients' tongue and facial diagnosis with blood biochemical indicators, metabolomics and other data. This is helpful to reveal the disease occurrence pattern of patients with blood stasis type psoriasis and construct a diagnostic model for blood stasis syndrome of psoriasis. At the same time, it provides a powerful decision support tool for clinical practice and also helps deepen our understanding of the complex process of the occurrence of blood stasis type psoriasis, thereby providing a solid scientific basis for formulating precise diagnostic and treatment strategies.

Although mechanical thrombectomy or thrombolytic therapy for large vessels can achieve a revascularization rate (TICI ≥2b) of over 90%, 30-50% of patients still exhibit poor functional outcomes. This phenomenon of "ineffective reperfusion" suggests that microcirculatory dysfunction plays a decisive role in post-stroke neural injury. Therefore, it is necessary to combine brain protection strategies with microcirculatory reperfusion therapy to improve the functional prognosis of stroke patients.Increasing cerebral blood flow (CBF) and neurovascular unit (NVU)-based cerebral protection are current hotspots in the emergency treatment of stroke. Galantamine, extracted from Lycoris aurea (a traditional Chinese medicinal herb), is an acetylcholinesterase inhibitor (AChEI) that has been widely recognized for improving cerebral blood flow and modulating inflammatory responses in ischemic stroke (IS). Therefore, the applicant will conduct an internationally compliant, randomized controlled clinical study with routine treatment to evaluate the efficacy of galantamine in the treatment of acute cerebral infarction. This project will conduct a comprehensive assessment of the drug's efficacy from multiple aspects, including improvements in stroke-related outcomes, Traditional Chinese Medicine (TCM) syndrome manifestations, cognitive function, cerebral blood flow, and inflammatory factors.

This study used a multicentre parallel three-armed randomised sham-controlled clinical trial methodology in order to objectively and normatively assess the efficacy of acupuncture on Quchi the Sea of Blood the Foot Sanli and the Sanyinjiao in the treatment of moderate-to-severe atopic dermatitis so as to obtain high-level evidence-based medical evidence. This study adopts a multi-centre, parallel, three-armed, randomized, sham-controlled clinical trial method, and will be conducted at Yueyang Hospital of Integrative Medicine affiliated with Shanghai University of Traditional Chinese Medicine, Huashan Hospital affiliated with Fudan University, and Seventh People's Hospital affiliated with Shanghai University of Traditional Chinese Medicine. Eligible patients with moderate-to-severe AD will be divided into three groups using stratified block randomisation in the ratio of 2:2:1: the acupuncture group, the sham-acupuncture group and the waitlisted control group. The total observation period is 9 weeks, including a 1-week introduction period, a 4-week treatment period and a 4-week follow-up period.

Psoriasis is a globally prevalent chronic relapsing skin disease, characterized by its long duration and tendency to relapse. In addition to skin symptoms, it can also affect nails and joints, leading to pathological features such as pitting, leukonychia, red lunula, or severe nail dystrophy. Some patients with psoriasis may develop psoriatic arthritis. Psoriatic arthritis (PsA) is a chronic relapsing musculoskeletal disease, characterized by psoriatic skin lesions accompanied by axial and peripheral joint damage, and often associated with characteristic manifestations of psoriatic nails. These nail changes typically indicate more severe disease and poorer prognosis. However, current diagnostic methods largely depend on the experience and professional knowledge of clinicians, which are subjective and uncertain. Moreover, histopathological examination is invasive and can cause additional pain and inconvenience to patients. To develop an effective, convenient, and non-invasive early diagnostic tool for psoriasis, our research team has conducted in-depth studies in the field of psoriasis-related diagnosis and predictive models. We have successfully developed a predictive model for psoriatic arthritis, including six key predictive factors: history of joint swelling, history of arthritis, history of swelling and pain in fingers or toes, nail involvement, genital involvement, and a history of long-term local use of corticosteroids. Clinicians can effectively assess the risk of psoriatic arthritis by obtaining information about these six factors from patients. The paper "Early detection of psoriatic arthritis in patients with psoriasis: construction of a multifactorial prediction model" was published in Front. Immunol (DOI: 10.3389/fimmu.2024.1426127). Raman spectroscopy is a rapid, non-invasive molecular vibration detection method that has shown great potential in medical diagnostics. Studies have shown that Raman spectroscopy can distinguish normal and abnormal tissues at the molecular level and has been proven feasible in nail testing. For psoriasis, a disease that causes significant nail changes, Raman spectroscopy offers unique advantages. Based on this background, our project will conduct a prospective observational study on psoriasis and psoriatic arthritis using multidimensional nail data. We will integrate Raman spectroscopy data of nails and multidimensional clinical information and apply artificial intelligence algorithms to develop a new diagnostic tool for psoriasis and psoriatic arthritis. This tool aims to improve the accuracy and efficiency of diagnosis, providing strong support for the early detection and precise treatment of psoriasis and psoriatic arthritis.

This research employs a cross-sectional study and a retrospective cohort study to analyze the liver safety of statin use among inpatients in the neurology department in China from different perspectives. The aim is to supplement evidence-based medicine and provide guidance for the clinical use of statins.

Psoriasis (PsO) is a common chronic relapsing inflammatory disease, induced by a combination of genetic and environmental effects, which seriously affects the quality of life of patients.Psoriasis Area and Severity Index（PASI score ） ，as the most common method used by clinicians to assess the severity of psoriasis and the effectiveness of treatment, has the disadvantage of being subjective and superficial.We are therefore committed to establishing an objective, real-time, repeatable, non-invasive, microscopic assessment using high-frequency ultrasound. This study will use high-frequency ultrasound to detect the patient's lesion site and the 2cm site next to the lesion once, and the study will continue to recruit for 6 months.

The aim of this clinical trial is to assess the therapeutic efficacy of acupuncture combined with neuromodulation techniques for the treatment of post-stroke aphasia and to explore the brain mechanisms involved. The study seeks to answer two primary questions: the effectiveness of the integrated intervention of acupuncture and repetitive transcranial magnetic stimulation (rTMS) on post-stroke aphasia, and the mechanisms underlying language function impairment and recovery. The research is divided into two parts: Part One: Participants will be randomized into two groups: Group A: Receives low-frequency rTMS followed by high-frequency rTMS. Group B: Receives high-frequency rTMS followed by low-frequency rTMS. Part Two: Participants will be randomized into four groups: rTMS Experimental Group: Individualized targets and intervention methods based on integrated fMRI and behavioral data. The rTMS intervention involves continuous treatment for two weeks, 5 sessions per week, each lasting 10-25 minutes, at 80% of the active motor threshold (AMT). rTMS Control Group: Standard rTMS protocol guided by clinical recommendations, with continuous treatment for two weeks, 5 sessions per week, each 20 minutes, at 80% AMT. Electroacupuncture Group: Points include Speech Area 1 (Yan Yu Yi Qu 1), Speech Area 2 (Yan Yu Yi Qu 2), Fengchi (Fengchi, GB20), Tiantu (Tiantu, CV22), Tongli (Tongli, HT5), Lianquan (Lianquan, CV23), and Paralianquan (Pang Lianquan). After needle insertion and obtaining Qi, electrical stimulation is applied with a discontinuous wave at 2Hz, at a tolerable intensity for the patient, for 30 minutes each session. Combined rTMS and Electroacupuncture Group: Combines both intervention methods as described above.

This multicenter, randomized, double-blind, placebo-controlled will be conducted at Yueyang Hospital of Integrative Medicine, Shanghai University of Traditional Chinese Medicine; Seventh People's Hospital, Shanghai University of Traditional Chinese Medicine; Jiading District Hospital of Traditional Chinese Medicine, Shanghai; and Baoshan District Hospital of Integrative Medicine, Shanghai; Huashan Hospital affiliated with Fudan University, Longhua Hospital affiliated with Shanghai University of Traditional Chinese Medicine, Shuguang Hospital affiliated with Shanghai University of Traditional Chinese Medicine, and the First Affiliated Hospital of the Naval Medical University. Approximately 376 participants will be recruited and randomly assigned to the Trilinolein cream or cream base group using block group randomization. The primary outcome will be time to relapse (number of days from the start of dosing to the time of relapse rating), and secondary outcomes will include eczema area and severity indices, overall investigator ratings, visual itch analog scores, dermatologic quality of life indices, overall improvement rates, and safety metrics. All data from the study will be analyzed using the SPSS 23.0 statistical package.

Psoriasis is a common chronic and systemic immune-mediated disease, induced by a combination of genetic and environmental effects. The increasingly worrying question is the negative impact on patients' sleep, which has become an important comorbidity of psoriasis. To investigate the causal relationship between psoriasis and sleep status, a prospective cohort study will be conducted by separating moderate-to-severe psoriasis patients and healthy individuals into distinct cohorts in order to observe their sleep status.

This cohort study involves the dynamic collection of clinical information, including serum parameters , blood pressure variability, imaging data, and neuropsychological scales, in patients with cerebral small vessel disease (CSVD). The study aims to summarise the clinical and imaging characteristics of the CSVD population and identify novel CSVD risk factors. Additionally, this study intend to uncover the mechanisms underlying the clinical and imaging outcomes of CSVD. Furthermore, a multivariable prediction model for cognitive and mood disorders in patients with CSVD will be established.