[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563649":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":43,"studyPopulation":43,"armGroups":50,"interventions":68,"overallOfficials":43,"centralContacts":81,"locations":87,"responsibleParty":134,"collaborators":138,"id":141,"slug":43,"hasResults":142,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":43,"eligibilityCriteria":146,"healthyVolunteers":142,"sex":147,"minAge":148,"maxAge":149,"enrollmentInfo":150,"targetDuration":43,"studyType":153,"phases":154,"briefSummary":156,"conditions":157,"keywords":159,"overallStatus":90,"whyStopped":43,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},{"fullName":5,"class":6},"The Third Affiliated hospital of Zhejiang Chinese Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":35},[9,13],{"measure":10,"description":11,"timeFrame":12},"Symptom Improvement Rate at Week 4","The primary outcome is the percentage of participants experiencing symptom improvement using the 7-point Likert scale for Overall Treatment Effect (OTE).\n\nThe Overall Treatment Effect (OTE) questionnaire was categorized as \"extremely worse than baseline,\" \"worse than baseline,\" \"slightly worse than baseline,\" \"no change,\" \"slightly improved than baseline,\" \"improved than baseline,\" or \"much improved than baseline.\"\n\nParticipants will rate their symptom severity compared to baseline, and those reporting \"improved than baseline\" or \"much improved than baseline\"will be considered responders.\n\nThe primary outcome will assess the efficacy of 5 Hz and 100 Hz electroacupuncture compared to sham treatment.","4 weeks after the start of treatment.",{"measure":14,"description":15,"timeFrame":12},"Main Symptom Resolution Rate at Week 4","The second primary outcome is the rate of complete resolution of the main symptoms of functional dyspepsia at week 4. For Postprandial Distress Syndrome (PDS), the primary symptoms are postprandial fullness and early satiety; for Epigastric Pain Syndrome (EPS), the main symptoms are epigastric pain and burning. Complete resolution is defined as a score of 0 for the respective main symptoms on a validated symptom severity scale.\n\nThe severity of each symptom is divided into: no symptoms (0 points), mild (1 point), moderate (2 points), and severe (3 points).\n\nThe outcome will compare the resolution rates between the 5 Hz, 100 Hz, and sham electroacupuncture groups.",[17,21,24,27,31],{"measure":18,"description":19,"timeFrame":20},"Global Overall Symptom (GOS) Score Change","The Global Overall Symptom (GOS) score assesses eight symptoms associated with functional dyspepsia (e.g., epigastric pain, burning, fullness, early satiety, nausea, bloating). Scores range from 1 (no problem) to 7 (very severe problem).\n\nScoring is as follows: 1 = no problem (no symptoms); 2 = minimal problem (can be easily ignored); 3 = mild problem (can be ignored with effort); 4 = moderate problem (cannot be ignored, but does not interfere with daily activities); 5 = moderately severe problem (cannot be ignored, occasionally limits daily activities); 6 = severe problem (cannot be ignored, often limits concentration on daily activities); 7 = very severe problem (cannot be ignored, severely limits daily activities.\n\nThe change from baseline to week 4 will be compared between the 5 Hz, 100 Hz, and sham electroacupuncture groups.","Baseline to Week 4",{"measure":22,"description":23,"timeFrame":20},"Nepean Dyspepsia Index (NDI) Score Change","The Nepean Dyspepsia Index (NDI) evaluates the impact of dyspepsia on patients \\'quality of life across five domains (e.g., tension, interference with daily activities). The change in NDI score from baseline to week 4 will be used to assess the efficacy of the interventions in improving quality of life.\n\nHigher scores on the Nepean Dyspepsia Index (NDI) indicate more severe symptoms",{"measure":25,"description":26,"timeFrame":20},"Hospital Anxiety and Depression Scale (HADS) Score Change","The Hospital Anxiety and Depression Scale (HADS) measures levels of anxiety and depression, which are often associated with functional dyspepsia. Changes in HADS scores from baseline to week 4 will be evaluated to determine if electroacupuncture has an impact on emotional well-being.\n\nThe scores of anxiety and depression subscales are divided into: 0-7 points for no symptoms; 8-10 points for suspected presence; 11-21 points for definite presence; When scoring, 8 points is the starting point, that is, both suspected and symptomatic are positive.",{"measure":28,"description":29,"timeFrame":30},"Treatment Expectation Score","Participants\\' expectations regarding the effectiveness of electroacupuncture will be assessed using a 5-point Likert scale (e.g., strongly agree to strongly disagree) prior to the first treatment. This outcome will be used to determine the role of treatment expectations in the perceived efficacy of electroacupuncture.","Prior to the first treatment (Baseline)",{"measure":32,"description":33,"timeFrame":34},"Blind evaluation","Participants perception of whether they received real or sham electroacupuncture will be assessed after the 1st and 6th treatment sessions to evaluate the effectiveness of blinding in the sham group.","immediately after 1st and 6th treatment sessions",[36],{"measure":37,"description":38,"timeFrame":39},"Subgroup Analysis of Symptom Improvement by FD Subtypes (PDS vs. EPS)","This outcome will assess whether the efficacy of 5 Hz and 100 Hz electroacupuncture differs between patients with Postprandial Distress Syndrome (PDS) and Epigastric Pain Syndrome (EPS). The primary and secondary outcome measures (symptom improvement, main symptom resolution, and quality of life scores) will be analyzed separately for these two subgroups. The comparison aims to determine if electroacupuncture has varying levels of effectiveness depending on the functional dyspepsia subtype.","At Week 4",{"allocation":41,"interventionModel":42,"interventionModelDescription":43,"primaryPurpose":44,"observationalModel":43,"timePerspective":43,"maskingInfo":45},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":46,"maskingDescription":43,"whoMasked":47},"DOUBLE",[48,49],"PARTICIPANT","OUTCOMES_ASSESSOR",[51,57,62],{"label":52,"type":53,"description":54,"interventionNames":55},"5 Hz Electroacupuncture Group","EXPERIMENTAL","Participants will receive electroacupuncture at a frequency of 5 Hz at four acupoints: Liangmen (ST21) and Tianshu (ST25) (local acupoints), and Zusanli (ST36) and Xiajuxu (ST39) (distal acupoints). Disposable needles will be inserted until the \"deqi\" sensation is achieved. The needles will be connected to an SDZ-IIB electroacupuncture device set at 5 Hz, with stimulation lasting 30 minutes per session. Participants will receive 3 sessions per week for 4 weeks (total: 12 sessions). This group aims to evaluate the efficacy of low-frequency electroacupuncture for treating functional dyspepsia.",[56],"Other: 5 Hz electroacupuncture",{"label":58,"type":53,"description":59,"interventionNames":60},"100 Hz Electroacupuncture Group","Participants will receive electroacupuncture at a frequency of 100 Hz at the same four acupoints: Liangmen (ST21), Tianshu (ST25), Zusanli (ST36), and Xiajuxu (ST39). Needles will be inserted to induce the \"deqi\" sensation and connected to an SDZ-IIB device set at 100 Hz, with stimulation lasting 30 minutes per session. Participants will receive 3 sessions per week for 4 weeks (total: 12 sessions). This group assesses the efficacy of high-frequency electroacupuncture for functional dyspepsia.",[61],"Other: 100 Hz electroacupuncture",{"label":63,"type":64,"description":65,"interventionNames":66},"Sham Electroacupuncture (Control) Group","SHAM_COMPARATOR","Participants will receive sham electroacupuncture at the same acupoints: Liangmen (ST21), Tianshu (ST25), Zusanli (ST36), and Xiajuxu (ST39). Non-penetrating needles will touch the skin but will not induce \"deqi.\" A sham electroacupuncture device (no actual current) will be used, and treatment will last 30 minutes per session. Participants will receive 3 sessions per week for 4 weeks (total: 12 sessions). This arm serves as a placebo control to evaluate the true effect of electroacupuncture.",[67],"Other: Sham electroacupuncture",[69,73,77],{"type":6,"name":70,"description":71,"armGroupLabels":72,"otherNames":43},"5 Hz electroacupuncture","Intervention Description:\n\nThe intervention in this study involves the use of electroacupuncture (EA), a combination of traditional acupuncture and electrical stimulation.\n\nAcupoints Selection: Electroacupuncture will be performed at specific acupoints associated with the stomach and digestive system. The local acupoints chosen are Liangmen (ST21) and Tianshu (ST25), while the distal acupoints are Zusanli (ST36) and Xiajuxu (ST39). This selection is based on Traditional Chinese Medicine (TCM) principles for treating functional dyspepsia.\n\nFrequency: 5 Hz",[52],{"type":6,"name":74,"description":75,"armGroupLabels":76,"otherNames":43},"Sham electroacupuncture","Participants will receive sham electroacupuncture at the same acupoints: Liangmen (ST21), Tianshu (ST25), Zusanli (ST36), and Xiajuxu (ST39). Non-penetrating needles will touch the skin but will not induce \\"deqi.\\" A sham electroacupuncture device (no actual current) will be used, and treatment will last 30 minutes per session. Participants will receive 3 sessions per week for 4 weeks (total: 12 sessions). This arm serves as a placebo control to evaluate the true effect of electroacupuncture.",[63],{"type":6,"name":78,"description":79,"armGroupLabels":80,"otherNames":43},"100 Hz electroacupuncture","Intervention Description:\n\nThe intervention in this study involves the use of electroacupuncture (EA), a combination of traditional acupuncture and electrical stimulation.\n\nAcupoints Selection: Electroacupuncture will be performed at specific acupoints associated with the stomach and digestive system. The local acupoints chosen are Liangmen (ST21) and Tianshu (ST25), while the distal acupoints are Zusanli (ST36) and Xiajuxu (ST39). This selection is based on Traditional Chinese Medicine (TCM) principles for treating functional dyspepsia.\n\nFrequency: 100 Hz",[58],[82],{"name":83,"role":84,"phone":85,"phoneExt":43,"email":86},"Yi Liang, Doctor","CONTACT","+86 571 86633328","liangyiwww@126.com",[88,107,117,124],{"facility":89,"status":90,"city":91,"state":92,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":102},"The Third Affiliated Hospital of Zhejiang Chinese Medicinal University","RECRUITING","Hangzhou","None Selected","310053","China","CN",{"type":97,"coordinates":98},"Point",[99,100],120.16142,30.29365,{"lat":100,"lon":99},[103],{"name":104,"role":84,"phone":105,"phoneExt":43,"email":106},"Chenben Zhang","+86-18815051075","zsy980714@gmail.com",{"facility":108,"status":90,"city":91,"state":109,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":110,"geoPoint":112,"contacts":113},"Hangzhou First People's Hospital","Zhejiang",{"type":97,"coordinates":111},[99,100],{"lat":100,"lon":99},[114],{"name":115,"role":84,"phone":116,"phoneExt":43,"email":106},"siyi zheng","+86-15990088547",{"facility":118,"status":90,"city":91,"state":109,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":119,"geoPoint":121,"contacts":122},"Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of Medicine",{"type":97,"coordinates":120},[99,100],{"lat":100,"lon":99},[123],{"name":115,"role":84,"phone":116,"phoneExt":43,"email":106},{"facility":125,"status":90,"city":91,"state":109,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":126,"geoPoint":128,"contacts":129},"The First Affiliated Hospital of Zhejiang Chinese Medical University",{"type":97,"coordinates":127},[99,100],{"lat":100,"lon":99},[130],{"name":131,"role":84,"phone":132,"phoneExt":43,"email":133},"Xiaojing Wang","+86-19857011126","1041073233@qq.com",{"type":135,"investigatorFullName":136,"investigatorTitle":137,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"SPONSOR_INVESTIGATOR","Yi Liang","Research Fellow",[139],{"name":140,"class":6},"Zhejiang University of Science and Technology","100563649",false,"NCT06618911","Evaluation of the Efficacy of Electroacupuncture in the Treatment of Functional Dyspepsia","Evaluation of the Efficacy of Electroacupuncture in the Treatment of Functional Dyspepsia: A Pilot Study","Inclusion Criteria:\n\n* Diagnosed with functional dyspepsia based on Rome IV diagnostic criteria.\n* Aged 18 to 80 years, inclusive, with no gender restrictions.\n* Normal endoscopy results within the past year, showing no structural explanation for symptoms.\n* No acupuncture treatment in the last month.\n* Not participating in any other clinical trials in the past 2 months.\n* Able to understand and provide informed consent.\n\nExclusion Criteria:\n\n* Presence of serious or malignant diseases (e.g., cirrhosis, heart failure, gastrointestinal tumors) that could explain dyspepsia symptoms.\n* Positive for Helicobacter pylori infection based on C-13 urea breath test or gastric biopsy.\n* History of gastrointestinal surgery (excluding laparoscopic and other minimally invasive surgeries).\n* Recent use (within 2 weeks) of medications affecting dyspepsia, including prokinetics, proton pump inhibitors, antacids, or antidepressants.\n* Presence of severe mental or physical conditions, such as dementia or illiteracy, that could interfere with study participation.\n* Severe coagulation disorders.\n* Substance abuse or alcohol dependence.\n* Pregnant or breastfeeding women.","ALL","18 Years","80 Years",{"count":151,"type":152},180,"ESTIMATED","INTERVENTIONAL",[155],"NA","Brief Summary Template for the Study:\n\nThe goal of this clinical trial is to evaluate whether electroacupuncture can treat functional dyspepsia (FD) in adult participants aged 18 to 65 years, including both males and females, who have been diagnosed with functional dyspepsia based on the Rome IV criteria. The main questions it aims to answer are:\n\n* Does 5 Hz electroacupuncture improve symptoms in functional dyspepsia patients?\n* Does 100 Hz electroacupuncture improve symptoms in functional dyspepsia patients?\n* Are there differences in the efficacy between 5 Hz and 100 Hz electroacupuncture in treating functional dyspepsia and its subtypes (PDS and EPS)?\n\nResearchers will compare the effects of 5 Hz electroacupuncture, 100 Hz electroacupuncture, and sham electroacupuncture to determine which approach provides more significant symptom relief and whether different frequencies have varying impacts on FD subtypes.\n\nParticipants will:\n\n* Receive electroacupuncture treatment at specific acupoints (such as Liangmen, Tianshu, Zusanli, and Xiajuxu) for 30-minute sessions, 3 times a week for 4 weeks.\n* Be randomly assigned to one of the following groups: 5 Hz electroacupuncture, 100 Hz electroacupuncture, or sham electroacupuncture (control).\n* Have their functional dyspepsia symptoms, quality of life, and any adverse effects monitored and evaluated throughout the study.",[158],"Functional Dyspepsia",[160,161],"electroacupuncture","functional dyspepsia","2025-08-24",{"date":164,"type":165},"2025-08-29","ACTUAL",{"date":167,"type":165},"2025-04-13",{"date":169,"type":152},"2026-09-30",{"name":136,"class":6},4]