[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":87},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100652168","clinical-study-of-zuogui-jiangtang-shuluo-formula-in-treating-diabetic-peripheral-neuropathy-100652168",false,"NCT07771894","Clinical Study of Zuogui Jiangtang Shuluo Formula in Treating Diabetic Peripheral Neuropathy","Mechanistic Study of Zuogui Jiangtang Shuluo Formula in Regulating Lipid Metabolism and Inhibiting Ferroptosis for the Prevention and Treatment of Diabetic Peripheral Neuropathy","DSPN inclusion criteria:\n\n1. Meet the diagnostic criteria for type 2 diabetes mellitus with distal symmetric polyneuropathy (DSPN) according to Western medicine standards.\n2. Meet the TCM syndrome differentiation criteria for consumptive thirst complicated with arthromyodynia of the pattern of Qi-Yin deficiency with blood stasis.\n3. Glycated hemoglobin (HbA1c) between 6.5% and 9.0% (inclusive).\n4. Aged 35 to 75 years (inclusive) at the time of screening, regardless of gender.\n5. Have not participated in any other clinical trial within 2 weeks prior to the start of treatment, and have not taken lipid-lowering agents, antibiotics, non-steroidal anti-inflammatory drugs (NSAIDs), antidepressants, immunosuppressants, or other traditional Chinese medicines that may affect metabolomic and lipidomic profiles.\n6. Willing to voluntarily participate in the trial and adhere to the 4-week traditional Chinese medicine treatment regimen.\n7. Right-handed.\n8. Provide written informed consent and are able to understand and comply with the study protocol requirements, including dietary and exercise recommendations and blood glucose monitoring.\n\nDSPN exclusion criteria\n\n1. Patients with type 1 diabetes mellitus or other specific types of diabetes mellitus.\n2. Women who are pregnant, breastfeeding, planning pregnancy, or taking oral contraceptives long-term.\n3. Neuropathies caused by other conditions, including but not limited to multiple sclerosis, Parkinson's disease, Guillain-Barré syndrome, epilepsy, spinal cord injury, cervical or lumbar spine lesions (nerve root compression, spinal stenosis, cervical or lumbar degenerative diseases), neuromuscular diseases, severe arterial or venous vascular diseases (venous thrombosis, lymphangitis, etc.), sequelae of cerebrovascular disease, or post-surgical status of lower extremity vasculature.\n4. History of stroke, transient ischemic attack, unstable angina, or myocardial infarction within 3 months prior to study enrollment.\n5. History of acute diabetic complications (diabetic ketoacidosis, lactic acidosis, or hyperosmolar hyperglycemic state) within 3 months prior to study enrollment.\n6. Concomitant severe complications of diabetes, such as end-stage diabetic kidney disease, or proliferative diabetic retinopathy.\n7. Concomitant severe diseases of the heart, liver, kidney, cerebrovascular system, or malignant tumors, defined as serum creatinine \\>200 μmol\u002FL, blood urea nitrogen \\>1.5 times the upper limit of normal, or alanine aminotransferase or aspartate aminotransferase \\>3 times the upper limit of normal.\n8. Any infection that, in the investigator's opinion, makes the patient unsuitable for participation prior to study enrollment, including but not limited to urinary tract infection, respiratory infection, or diabetic foot with infection requiring further treatment.\n9. Patients with psychiatric disorders, cognitive impairment, or inability to cooperate with the study procedures; or individuals with a history of alcohol abuse or drug addiction.\n\nHealthy volunteer inclusion criteria:\n\n1. Aged 18 to 55 years (inclusive) at the time of screening, regardless of gender.\n2. Body mass index (BMI) within the range of 19.0 to 26.0 kg\u002Fm² (inclusive). No severe diseases of the heart, liver, kidney, cerebrovascular system, or malignant tumors; routine laboratory tests, electrocardiogram, and chest X-ray are essentially within normal limits.\n3. Have not participated in any other clinical trial within 2 weeks prior to the start of treatment, and have not taken lipid-lowering agents, antibiotics, non-steroidal anti-inflammatory drugs (NSAIDs), antidepressants, immunosuppressants, or other traditional Chinese medicines that may affect metabolomic and lipidomic profiles.\n4. Voluntarily sign the informed consent form and are willing and able to cooperate with the investigators to complete the clinical study.\n\nHealthy volunteer exclusion criteria:\n\n1. Women who are pregnant, breastfeeding, planning pregnancy, or taking oral contraceptives long-term.\n2. Patients with psychiatric disorders, cognitive impairment, or inability to cooperate with the study procedures.\n3. Individuals with a history of alcohol abuse or drug addiction.",true,"ALL","35 Years","75 Years",{"count":21,"type":22},74,"ESTIMATED","INTERVENTIONAL",[25],"NA","Diabetic peripheral neuropathy (DPN) is a common complication of type 2 diabetes mellitus, affecting 35%-50% of diabetic patients. Its pathogenesis involves metabolic disorders induced by hyperglycemia and dyslipidemia, leading to irreversible damage to neurons and vascular endothelial cells. Distal symmetric polyneuropathy (DSPN) is the most representative form, characterized by distal pain, numbness, and sensory loss, which may progress to ulcers, gangrene, and even amputation in severe cases.\n\nCurrent modern medical treatments for DPN primarily focus on nutritional nerve support, antioxidative stress, and microcirculation improvement, but these approaches are limited in variety and may carry side effects. Traditional Chinese Medicine (TCM) offers advantages including higher safety and diverse therapeutic options.\n\nBased on long-term clinical observation, our research group proposes that the core pathogenesis of DPN is Qi-Yin deficiency with blood stasis obstructing collaterals. The treatment principle is to nourish Yin, supplement Qi, activate blood circulation, and unblock collaterals, with Zuogui Jiangtang Shuluo Formula (ZGJTSLF) as the primary prescription. Previous studies have shown that ZGJTSLF can improve TCSS scores and nerve conduction velocity in DPN patients compared with mecobalamin, but high-level evidence is still lacking.\n\nThis randomized, parallel-controlled trial aims to evaluate the clinical efficacy of ZGJTSLF in treating DPN, with TCSS score and nerve conduction velocity as primary outcomes. Metabolomics and lipidomics will be employed to compare metabolic profiles between healthy controls and DPN patients before and after ZGJTSLF treatment, aiming to identify potential biomarkers and explore the underlying mechanisms.",[28],"Diabetic Peripheral Neuropathy (DPN)",[30,31,32,33,34,35],"Diabetic Peripheral Neuropathy","Zuogui Jiangtang Shuluo Formula","DPN","Metabolomics","Lipidomics","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-08-14",{"date":39,"type":40},"2026-08-18","ACTUAL",{"date":42,"type":22},"2026-08-15",{"date":44,"type":22},"2027-09-15",{"name":46,"class":47},"The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":19,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":63,"conditions":64,"keywords":69,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":4},"100591617","phase-1-acupuncture-versus-compound-diclofenac-sodium-for-pain-relief-in-non-traumatic-acute-abdominal-100591617","NCT06982755","Acupuncture Versus Compound Diclofenac Sodium for Pain Relief in Non-Traumatic Acute Abdominal","Effect of Acupuncture on Early Analgesia of Non-traumatic Acute Abdomen is Discussed Based on the Experience of Sanli Acupoint for Du-fu Diseases :A Prospective Randomized Controlled pRCT Study","ACU-NTAA","Inclusion Criteria:\n\n1. The diagnostic criteria of NTAA were as follows: ① abdominal pain was the main symptom; ② The onset time was less than 1 week; ③ The cause of abdominal pain could be traced to intra-abdominal abdominal wall chest or systemic diseases;\n2. Patients with NRS scores ≥4 (mild pain and above) were evaluated before inclusion; （3）16 years \\\u003C age \\\u003C75 years;\n\n（4）Those who were considered not to need surgery within 2 hours after initial assessment by a specialist.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria were excluded from the study:\n\n1. Acute abdomen caused by trauma;\n2. Super sudden diseases (e.g. acute myocardial infarction rupture of abdominal aortic aneurysm pulmonary embolism aortic dissection pericardial tamponade);\n3. Emergent conditions requiring surgical treatment within 3 hours (e.g. rupture of liver cancer ectopic pregnancy ischemic bowel disease severe acute cholangitis peritonitis with septic shock);\n4. Extremely severe pain (NRS ≥ 8) with an undetermined diagnosis and requiring further assessment for a super sudden disease;\n5. Inability to select acupuncture points due to skin injury or ulceration at Zusanli (ST36) on the lower limb;\n6. Induration or infection at the hip injection site;\n7. Patients with altered consciousness mental illness other severe chronic diseases or those who are unlikely to cooperate with acupuncture treatment;\n8. Contraindications to Western medicine:\n\n   * Known allergies to diclofenac sodium or acetaminophen; ②History of asthma urticaria or allergic reactions induced by aspirin or other NSAIDs.\n\n     * Undergoing coronary artery bypass grafting (CABG) surgery. ④History of gastrointestinal bleeding or perforation following non-steroidal anti-inflammatory drugs (NSAIDs).\n\n       * Active gastrointestinal ulcers or bleeding or a history of recurrent ulcers or bleeding.\n\n         * Severe heart failure.\n9. Use of any pain medication or acupuncture within the past 6 hours;\n10. Previous participation in this study;\n11. Pregnant or lactating individuals.","16 Years",{"count":59,"type":22},176,[61,62],"PHASE1","PHASE2","The investigators designed this clinical study to evaluate the efficacy and safety of semi-standardized acupuncture and moxibustion combined with compound diclofenac sodium injection in the emergency department (ED) compared with acupuncture or compound diclofenac sodium injection alone.",[65,66,67,68],"Acute Abdominal Pain","Acupuncture Therapy","Acupuncture","Opioids",[70,71,72,73,67,74,75,76,68,77,78],"Acute abdominal pain","Non-Traumatic Acute Abdomen","Non-traumatic acute abdomen early analgesia","Acupuncture therapy","Zusanli point, ST36","Diclofenac sodium","Emergency environment","Non-steroidal anti-inflammatory drugs ，NSAIDs","Acetaminophen","2025-05-20",{"date":81,"type":40},"2025-05-21",{"date":83,"type":22},"2025-06-01",{"date":85,"type":22},"2026-12-31",{"name":46,"class":47},""]