Functional DyspepsiaNCT05920395
Mechanisms of Electroacupuncture for Functional Dyspepsia Based on "Enterotypes" and Metabolomics
A study testing Electro-acupuncture in people with Functional Dyspepsia, run by Wuhan Central Hospital.
Trial summary
The goal of this clinical trial is to explore the clinical efficacy and possible mechanisms of electroacupuncture treatment for functional dyspepsia (FD). The main question it aims to answer are: Differences in the effects of electroacupuncture and sham electroacupuncture intervention on FD. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- Electro-acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Meeting the Western medicine diagnostic criteria for FD;
- Aged 18-65 years (inclusive of 18 and 65 years old);
- Not having taken any gastrointestinal prokinetic drugs for at least 15 days before treatment, and not having participated in any other clinical studies;
- Voluntary signing of an informed consent form for this study. Note: Only patients who meet all four of the above criteria can be included in this study.
Who cannot join
- Pregnant or lactating women;
- Patients with severe organic digestive system diseases indicated by endoscopic examination, such as severe dysplasia or mucosal erosion, or pathological indication of malignancy;
- Patients with endocrine, cardiovascular, cerebrovascular, hematopoietic system, or neurological diseases such as diabetes, severe coronary heart disease, hypoglycemia, or hemiplegia;
- Patients with mental illness,infectious diseases, progressive malignant tumors,or life- threatening diseases;
- Patients who are afraid of acupuncture, have allergies or are allergic to medical supplies.
- Note: Patients who meet any of the above criteria will be excluded.
Show all 17Show fewer
- Removal criteria
- Cases that are mistakenly included due to concealment of illness information or failure to meet inclusion criteria should be excluded;
- Participants with poor compliance or those who withdraw from the study on their own during the treatment period, or those who use treatment methods prohibited by this protocol during the study phase;
- Participants who experience severe adverse events or complications and are unable to continue the treatment, and the trial is terminated;
- Participants who do not follow the prescribed treatment or whose data is incomplete, affecting efficacy and safety evaluation.
- Dropout criteria Participants who have been included but are unable to participate in the trial on time, or who do not follow the trial requirements, or who drop out during treatment.
- The handing of exclusion and dropout When a participant drops out, the researcher should contact them as much as possible through house visits, scheduled phone calls, letters, etc., to inquire about the reasons for dropout. record the date of the last treatment, and complete the evaluation items that can be completed. All cases of exclusion and dropout will be subjected to intention-to-treat analysis after the end of the trial.
- Research Termination Criteria
- If the condition worsens during the experiment or other serious illness occurs, it is determined that participation needs to be terminated or other treatments are necessary.
- If a serious adverse event occurs during the experiment that prevents further participation.
- The investigator should record the reason and time for withdrawing from the study. Those who have completed more than half of the treatment should be included in the efficacy statistics.
Trial locations and contacts
No sites are listed yet.
About this study
The goal of this clinical trial is to explore the clinical efficacy and possible mechanisms of electroacupuncture treatment for functional dyspepsia (FD). The main question it aims to answer are:
- Differences in the effects of electroacupuncture and sham electroacupuncture intervention on FD.
- Differences in gastrointestinal hormone levels and gut microbiota and their metabolites between healthy individuals and FD patients.
Participants receive electroacupuncture and sham electroacupuncture interventions respectively. Before and after the intervention, the clinical symptom score, gastrointestinal symptom evaluation scale, gastrointestinal symptom score questionnaire, and functional dyspepsia quality of life scale of the subjects will be observed. The levels of gastrointestinal hormones MTL, Ghrelin, 5-HT, CCK, PYY, and GLP-1 will be measured, as well as the changes in microbial diversity and SCFAs in their metabolites in feces, A follow-up visit will be conducted one month after the intervention for all participants.
Read the detailed description
Functional dyspepsia (FD) is a common and difficult clinical disease, and there is currently no effective treatment plan. Electroacupuncture is commonly used in clinical practice, but there is a lack of high-quality clinical evidence of its effectiveness. This study explores the clinical efficacy and possible mechanisms of electroacupuncture in the treatment of FD.
The study set up a healthy control group and an FD group. The FD group was divided into PDS type and EPS type according to their classification, and received electroacupuncture and sham electroacupuncture intervention, respectively. Before and after intervention, the clinical symptom score, gastrointestinal symptom evaluation scale, gastrointestinal symptom score questionnaire, and functional dyspepsia quality of life scale of the participants were observed. The levels of gastrointestinal hormones MTL, Ghrelin, 5-HT, CCK, PYY, GLP-1 were measured, and changes in fecal microbiota diversity and SCFAs in their metabolites were also detected. A follow-up visit will be conducted one month after the intervention for all participants.
Experiment 1: Observing the differences in various indicators between healthy individuals and FD patients Grouping: ① Healthy control group: 26 healthy volunteers, without any intervention, were tested for gastrointestinal hormone levels, gut microbiota, and their metabolites.② FD group: A total of 104 patients were included, and the levels of gastrointestinal hormones, gut microbiota, and their metabolites were detected after inclusion. The differences in gut type between the two groups of patients were analyzed.
Experiment 2: Observing the Effect of Electroacupuncture on FD Patients Grouping: The 104 FD patients included as required included 52 PDS type and 52 EPS type. Both types of patients were randomly assigned to the electroacupuncture group and the sham electroacupuncture group, with 26 patients in each group. It is divided into PDS electroacupuncture group (Group A), PDS sham electroacupuncture group (Group B), EPS electroacupuncture group (Group C), and EPS sham electroacupuncture group (Group D).
① Electroacupuncture group: including Group A and Group C, with 26 cases each, all receiving electroacupuncture treatment. The patient lies on his back on the treatment bed. After routine disinfection, a 0.30X50mm or 0.30X40mm disposable sterile acupuncture and moxibustion needle is directly punctured into the acupoint. After getting qi, the needling sensation is maintained by the manipulation of leveling, reinforcing and reducing. Point selection: Zhongwan, Zusanli, Neiguan, and Tianshu, connected to the 6805-AII electroacupuncture treatment instrument; Connect one set of electrodes to Zhongwan and Tianshu acupoints, with the positive electrode connected to Zhongwan acupoint and the negative electrode connected to Tianshu acupoint on one side; Using dense wave pulse stimulation with a frequency of 2Hz/100Hz, with a stimulation intensity that the patient can tolerate, 30 minutes each time, treated once every other day for a total of 4 weeks.
② False electroacupuncture: including group B and group D, with 26 cases each, with shallow acupuncture. After disconnecting the end of the electrode and binding it with black tape, the false electrode was connected without being electrified, and the rest were the same as the electroacupuncture group.
The positioning of acupoints shall refer to the positioning standards in the new century national planning textbook for higher Chinese medicine colleges and universities, "Meridian and Acupoint Science," edited by Shen Xueyong. A follow-up visit will be conducted one month after the intervention for all subjects.
During the intervention, all subjects did not take drug treatment. If the corresponding symptoms of the subjects such as abdominal pain, abdominal burning, early satiety and so on were significantly aggravated, the subjects would be given symptomatic treatment of the emergency drug pantoprazole sodium enteric coated tablets when the investigator diagnosed that drug intervention was needed. Participants can also consider choosing to seek treatment at the gastroenterology outpatient department. If needed, they can assist in contacting a specialist to provide corresponding professional diagnosis and treatment advice. Subjects receiving emergency medication or other medications that affect gastrointestinal motility need to terminate the study. If they have completed 1/2 course of treatment, the corresponding outcome indicators should be included in the efficacy statistics.
- Conditions
- Functional Dyspepsia
- Being tested
- Electro-acupuncture, Sham electro-acupuncture group
- Keywords
- Functional Dyspepsia, Electroacupuncture, Intestinal flora
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electro-acupunctureOther
Patients lie supine on the treatment bed, and after routine disinfection, a 0.30×60mm or 0.30×40mm disposable sterile acupuncture needle is inserted directly into the acupoint. Once obtaining qi, the needle is manipulated with even reinforcing and reducing techniques to maintain needle sensation. Acupoints selected include Zhongwan, Zusanli, Neiguan, and Tianshu, connected to the 6805-All electro-acupuncture therapy device. Zhongtuo and Tianshu acupoints are connected to a set of electrodes, with the positive pole connected to Zhongtuo and the negative pole connected to one side of Tianshu. The stimulation uses sparse and dense wave pulses with a frequency of 2Hz/100Hz, with the stimulation intensity determined based on individual patient tolerance. Each session lasts for 30 minutes, with a treatment frequency of once every other day, for a total of 4 weeks.
Sham electro-acupuncture groupOther
Shallow acupuncture needles are used and then disconnected from the electrode. They are tied with black tape and connected to the sham electrode. The device is not powered on, and the rest of the treatment is the same as the electro-acupuncture group.
| Study group | Role | What they receive |
|---|---|---|
| Healthy control group | No intervention | 26 healthy volunteers without any intervention, detecting gastrointestinal hormone levels and intestinal microbiota and their metabolites. |
| PDS electroacupuncture group | Experimental | Each with 26 patients who were treated with electro-acupuncture. Receives: Other: Electro-acupuncture |
| PDS sham electroacupuncture group | Sham comparator | Each with 26 patients. Shallow acupuncture needles are used and then disconnected from the electrode. Receives: Other: Sham electro-acupuncture group |
| EPS electroacupuncture group | Experimental | Each with 26 patients who were treated with electro-acupuncture. Receives: Other: Electro-acupuncture |
| EPS sham electroacupuncture group | Sham comparator | Each with 26 patients. Shallow acupuncture needles are used and then disconnected from the electrode. Receives: Other: Sham electro-acupuncture group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall efficacy evaluation
Refer to the efficacy criteria in the "Draft of Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment Plan for Functional Dyspepsia", and evaluate the efficacy based on four levels: clinical cure, marked improvement, improvement, and inefficacy. Calculate the efficacy index based on the total symptom score. Efficacy index = {(pre-treatment total symptom score - post-treatment total symptom score) ÷ pre-treatment total symptom score} × 100%.
Clinical Cure: Efficacy Index > 85%; Marked Improvement: Efficacy Index 5%-85%; Improvement: Efficacy Index 26%-50%; Inefficacy: Efficacy Index < 26%.
Measured: up to 4 weeks
Gastric electrogastrography (EGG) testing
The Hefei Scientific Experimental Instrument Factory's GAP-24A high-resolution gastrointestinal electrogastrography analysis system is used for testing. In the fasted state, the subject lies in a supine position, and electrodes are placed on the upper abdomen at the first lead of the gastric antrum (2-4 cm to the right of the midpoint between the xiphoid process and umbilicus) and the second lead of the gastric body (3-5 cm to the left of the midpoint between the xiphoid process and umbilicus, 1 cm upward). Conductive gel is applied locally to the skin, and a baseline EGG recording is made before conducting gastric EGG evaluation. After recording for 30 minutes, subjects are given a standard meal (50% carbohydrates, 25% protein, 25% fat, total energy intake of 570kcal, and 150mL water), which they eat within 15 minutes, followed by another EGG recording 5 minutes after eating. Recording continues for 30 minutes, with a sampling frequency of 4Hz.
Measured: baseline, pre-intervention
Gastric electrogastrography (EGG) testing
The Hefei Scientific Experimental Instrument Factory's GAP-24A high-resolution gastrointestinal electrogastrography analysis system is used for testing. In the fasted state, the subject lies in a supine position, and electrodes are placed on the upper abdomen at the first lead of the gastric antrum (2-4 cm to the right of the midpoint between the xiphoid process and umbilicus) and the second lead of the gastric body (3-5 cm to the left of the midpoint between the xiphoid process and umbilicus, 1 cm upward). Conductive gel is applied locally to the skin, and a baseline EGG recording is made before conducting gastric EGG evaluation. After recording for 30 minutes, subjects are given a standard meal (50% carbohydrates, 25% protein, 25% fat, total energy intake of 570kcal, and 150mL water), which they eat within 15 minutes, followed by another EGG recording 5 minutes after eating. Recording continues for 30 minutes, with a sampling frequency of 4Hz.
Measured: up to 4 weeks
Secondary outcomes (18)
Gastrointestinal Symptom Rating Scale (GSRS)
Evaluate each subject using the GSRS scale
Measured: baseline, pre-intervention
Gastrointestinal Symptom Rating Scale (GSRS)
Evaluate each subject using the GSRS scale
Measured: up to 4 weeks
Gastrointestinal Symptom Rating Scale (GSRS)
Evaluate each subject using the GSRS scale
Measured: up to 8 weeks
Gastrointestinal Symptom Score Questionnaire (GIS)
Evaluate each subject using the GIS scale
Measured: baseline, pre-intervention
Gastrointestinal Symptom Score Questionnaire (GIS)
Evaluate each subject using the GIS scale
Measured: up to 4 weeks
Gastrointestinal Symptom Score Questionnaire (GIS)
Evaluate each subject using the GIS scale
Measured: up to 8 weeks
Nepean Dyspepsia Index (NDI)
Evaluate each subject using the NDI scale
Measured: baseline, pre-intervention
Nepean Dyspepsia Index (NDI)
Evaluate each subject using the NDI scale
Measured: up to 4 weeks
Nepean Dyspepsia Index (NDI)
Evaluate each subject using the NDI scale
Measured: up to 8 weeks
Functional Dyspepsia Quality of Life questionnaire (FDQOL).
Evaluate each subject using the FDQOL scale
Measured: baseline, pre-intervention
Functional Dyspepsia Quality of Life questionnaire (FDQOL).
Evaluate each subject using the FDQOL scale
Measured: up to 4 weeks
Functional Dyspepsia Quality of Life questionnaire (FDQOL).
Evaluate each subject using the FDQOL scale
Measured: up to 8 weeks
Gastrointestinal hormone level testing
5mL of venous blood is drawn from the subject in a fasted state. After centrifugation at 3000 rpm for 10 minutes at 4℃, the plasma is separated and stored in a -80℃freezer. ELISA method is used to test the levels of MTL, Ghrelin, 5-HT, CCK, PYY, and GLP-1.
Measured: baseline, pre-intervention
Gastrointestinal hormone level testing
5mL of venous blood is drawn from the subject in a fasted state. After centrifugation at 3000 rpm for 10 minutes at 4℃, the plasma is separated and stored in a -80℃freezer. ELISA method is used to test the levels of MTL, Ghrelin, 5-HT, CCK, PYY, and GLP-1.
Measured: up to 4 weeks
Intestinal microbiota diversity testing
Approximately 5g of feces are collected using a sterile fecal collection tube from each subject anytime within three days before and after the start of intervention. The central portion of the feces is collected to avoid contamination with urine or other substances. Diarrhea or loose stools are excluded. The feces samples are stored in a -80℃ freezer for measurement. The QIAamp Fast DNA Stool kit is used for fecal DNA extraction, and 16S rDNA sequencing technology is used to analyze the composition and diversity of the intestinal microbial communities.
Measured: baseline, pre-intervention
Intestinal microbiota diversity testing
Approximately 5g of feces are collected using a sterile fecal collection tube from each subject anytime within three days before and after the start of intervention. The central portion of the feces is collected to avoid contamination with urine or other substances. Diarrhea or loose stools are excluded. The feces samples are stored in a -80℃ freezer for measurement. The QIAamp Fast DNA Stool kit is used for fecal DNA extraction, and 16S rDNA sequencing technology is used to analyze the composition and diversity of the intestinal microbial communities.
Measured: up to 4 weeks
Intestinal microbiota metabolite testing
Non-targeted metabolomics detection method is used to measure the content of SCFAs before and after intervention in healthy volunteers and each group using chromatography-mass spectrometry technology.
Measured: baseline, pre-intervention
Intestinal microbiota metabolite testing
Non-targeted metabolomics detection method is used to measure the content of SCFAs before and after intervention in healthy volunteers and each group using chromatography-mass spectrometry technology.
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920395
- Sponsor's protocol ID
- WZ22A06
- Status last verified
- Jun 2023
- First submitted
- 5 Jun 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Electroacupuncture for Functional Dyspepsia Based on "Enterotypes" and Metabolomics
- ClinicalTrials.gov ID
- NCT05920395
- Acronym / sponsor ID
- WZ22A06
- Conditions
- Functional Dyspepsia
- Keywords
- Functional Dyspepsia, Electroacupuncture, Intestinal flora
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Wuhan Central HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to explore the clinical efficacy and possible mechanisms of electroacupuncture treatment for functional dyspepsia (FD). The main question it aims to answer are:
- Differences in the effects of electroacupuncture and sham electroacupuncture intervention on FD.
- Differences in gastrointestinal hormone levels and gut microbiota and their metabolites between healthy individuals and FD patients.
Participants receive electroacupuncture and sham electroacupuncture interventions respectively. Before and after the intervention, the clinical symptom score, gastrointestinal symptom evaluation scale, gastrointestinal symptom score questionnaire, and functional dyspepsia quality of life scale of the subjects will be observed. The levels of gastrointestinal hormones MTL, Ghrelin, 5-HT, CCK, PYY, and GLP-1 will be measured, as well as the changes in microbial diversity and SCFAs in their metabolites in feces, A follow-up visit will be conducted one month after the intervention for all participants.
Detailed description
Functional dyspepsia (FD) is a common and difficult clinical disease, and there is currently no effective treatment plan. Electroacupuncture is commonly used in clinical practice, but there is a lack of high-quality clinical evidence of its effectiveness. This study explores the clinical efficacy and possible mechanisms of electroacupuncture in the treatment of FD.
The study set up a healthy control group and an FD group. The FD group was divided into PDS type and EPS type according to their classification, and received electroacupuncture and sham electroacupuncture intervention, respectively. Before and after intervention, the clinical symptom score, gastrointestinal symptom evaluation scale, gastrointestinal symptom score questionnaire, and functional dyspepsia quality of life scale of the participants were observed. The levels of gastrointestinal hormones MTL, Ghrelin, 5-HT, CCK, PYY, GLP-1 were measured, and changes in fecal microbiota diversity and SCFAs in their metabolites were also detected. A follow-up visit will be conducted one month after the intervention for all participants.
Experiment 1: Observing the differences in various indicators between healthy individuals and FD patients Grouping: ① Healthy control group: 26 healthy volunteers, without any intervention, were tested for gastrointestinal hormone levels, gut microbiota, and their metabolites.② FD group: A total of 104 patients were included, and the levels of gastrointestinal hormones, gut microbiota, and their metabolites were detected after inclusion. The differences in gut type between the two groups of patients were analyzed.
Experiment 2: Observing the Effect of Electroacupuncture on FD Patients Grouping: The 104 FD patients included as required included 52 PDS type and 52 EPS type. Both types of patients were randomly assigned to the electroacupuncture group and the sham electroacupuncture group, with 26 patients in each group. It is divided into PDS electroacupuncture group (Group A), PDS sham electroacupuncture group (Group B), EPS electroacupuncture group (Group C), and EPS sham electroacupuncture group (Group D).
① Electroacupuncture group: including Group A and Group C, with 26 cases each, all receiving electroacupuncture treatment. The patient lies on his back on the treatment bed. After routine disinfection, a 0.30X50mm or 0.30X40mm disposable sterile acupuncture and moxibustion needle is directly punctured into the acupoint. After getting qi, the needling sensation is maintained by the manipulation of leveling, reinforcing and reducing. Point selection: Zhongwan, Zusanli, Neiguan, and Tianshu, connected to the 6805-AII electroacupuncture treatment instrument; Connect one set of electrodes to Zhongwan and Tianshu acupoints, with the positive electrode connected to Zhongwan acupoint and the negative electrode connected to Tianshu acupoint on one side; Using dense wave pulse stimulation with a frequency of 2Hz/100Hz, with a stimulation intensity that the patient can tolerate, 30 minutes each time, treated once every other day for a total of 4 weeks.
② False electroacupuncture: including group B and group D, with 26 cases each, with shallow acupuncture. After disconnecting the end of the electrode and binding it with black tape, the false electrode was connected without being electrified, and the rest were the same as the electroacupuncture group.
The positioning of acupoints shall refer to the positioning standards in the new century national planning textbook for higher Chinese medicine colleges and universities, "Meridian and Acupoint Science," edited by Shen Xueyong. A follow-up visit will be conducted one month after the intervention for all subjects.
During the intervention, all subjects did not take drug treatment. If the corresponding symptoms of the subjects such as abdominal pain, abdominal burning, early satiety and so on were significantly aggravated, the subjects would be given symptomatic treatment of the emergency drug pantoprazole sodium enteric coated tablets when the investigator diagnosed that drug intervention was needed. Participants can also consider choosing to seek treatment at the gastroenterology outpatient department. If needed, they can assist in contacting a specialist to provide corresponding professional diagnosis and treatment advice. Subjects receiving emergency medication or other medications that affect gastrointestinal motility need to terminate the study. If they have completed 1/2 course of treatment, the corresponding outcome indicators should be included in the efficacy statistics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy control group | No intervention | –26 healthy volunteers without any intervention, detecting gastrointestinal hormone levels and intestinal microbiota and their metabolites. |
| PDS electroacupuncture group | Experimental | Other: Electro-acupunctureEach with 26 patients who were treated with electro-acupuncture. |
| PDS sham electroacupuncture group | Sham comparator | Other: Sham electro-acupuncture groupEach with 26 patients. Shallow acupuncture needles are used and then disconnected from the electrode. |
| EPS electroacupuncture group | Experimental | Other: Electro-acupunctureEach with 26 patients who were treated with electro-acupuncture. |
| EPS sham electroacupuncture group | Sham comparator | Other: Sham electro-acupuncture groupEach with 26 patients. Shallow acupuncture needles are used and then disconnected from the electrode. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meeting the Western medicine diagnostic criteria for FD;
- Aged 18-65 years (inclusive of 18 and 65 years old);
- Not having taken any gastrointestinal prokinetic drugs for at least 15 days before treatment, and not having participated in any other clinical studies;
- Voluntary signing of an informed consent form for this study. Note: Only patients who meet all four of the above criteria can be included in this study.
Key exclusion criteria (17 listed)
- Pregnant or lactating women;
- Patients with severe organic digestive system diseases indicated by endoscopic examination, such as severe dysplasia or mucosal erosion, or pathological indication of malignancy;
- Patients with endocrine, cardiovascular, cerebrovascular, hematopoietic system, or neurological diseases such as diabetes, severe coronary heart disease, hypoglycemia, or hemiplegia;
- Patients with mental illness,infectious diseases, progressive malignant tumors,or life- threatening diseases;
- Patients who are afraid of acupuncture, have allergies or are allergic to medical supplies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electro-acupuncturePatients lie supine on the treatment bed, and after routine disinfection, a 0.30×60mm or 0.30×40mm disposable sterile acupuncture needle is inserted directly into the acupoint. Once obtaining qi, the needle is manipulated with even reinforcing and reducing techniques to maintain needle sensation. Acupoints selected include Zhongwan, Zusanli, Neiguan, and Tianshu, connected to the 6805-All electro-acupuncture therapy device. Zhongtuo and Tianshu acupoints are connected to a set of electrodes, with the positive pole connected to Zhongtuo and the negative pole connected to one side of Tianshu. The stimulation uses sparse and dense wave pulses with a frequency of 2Hz/100Hz, with the stimulation intensity determined based on individual patient tolerance. Each session lasts for 30 minutes, with a treatment frequency of once every other day, for a total of 4 weeks. | Other | EPS electroacupuncture group, PDS electroacupuncture group |
| Sham electro-acupuncture groupShallow acupuncture needles are used and then disconnected from the electrode. They are tied with black tape and connected to the sham electrode. The device is not powered on, and the rest of the treatment is the same as the electro-acupuncture group. | Other | EPS sham electroacupuncture group, PDS sham electroacupuncture group |
Primary outcome
Overall efficacy evaluation
Time frame: up to 4 weeks
Refer to the efficacy criteria in the "Draft of Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment Plan for Functional Dyspepsia", and evaluate the efficacy based on four levels: clinical cure, marked improvement, improvement, and inefficacy. Calculate the efficacy index based on the total symptom score. Efficacy index = {(pre-treatment total symptom score - post-treatment total symptom score) ÷ pre-treatment total symptom score} × 100%. Clinical Cure: Efficacy Index > 85%; Marked Improvement: Efficacy Index 5%-85%; Improvement: Efficacy Index 26%-50%; Inefficacy: Efficacy Index < 26%.
Gastric electrogastrography (EGG) testing
Time frame: baseline, pre-intervention
The Hefei Scientific Experimental Instrument Factory's GAP-24A high-resolution gastrointestinal electrogastrography analysis system is used for testing. In the fasted state, the subject lies in a supine position, and electrodes are placed on the upper abdomen at the first lead of the gastric antrum (2-4 cm to the right of the midpoint between the xiphoid process and umbilicus) and the second lead of the gastric body (3-5 cm to the left of the midpoint between the xiphoid process and umbilicus, 1 cm upward). Conductive gel is applied locally to the skin, and a baseline EGG recording is made before conducting gastric EGG evaluation. After recording for 30 minutes, subjects are given a standard meal (50% carbohydrates, 25% protein, 25% fat, total energy intake of 570kcal, and 150mL water), which they eat within 15 minutes, followed by another EGG recording 5 minutes after eating. Recording continues for 30 minutes, with a sampling frequency of 4Hz.
Gastric electrogastrography (EGG) testing
Time frame: up to 4 weeks
The Hefei Scientific Experimental Instrument Factory's GAP-24A high-resolution gastrointestinal electrogastrography analysis system is used for testing. In the fasted state, the subject lies in a supine position, and electrodes are placed on the upper abdomen at the first lead of the gastric antrum (2-4 cm to the right of the midpoint between the xiphoid process and umbilicus) and the second lead of the gastric body (3-5 cm to the left of the midpoint between the xiphoid process and umbilicus, 1 cm upward). Conductive gel is applied locally to the skin, and a baseline EGG recording is made before conducting gastric EGG evaluation. After recording for 30 minutes, subjects are given a standard meal (50% carbohydrates, 25% protein, 25% fat, total energy intake of 570kcal, and 150mL water), which they eat within 15 minutes, followed by another EGG recording 5 minutes after eating. Recording continues for 30 minutes, with a sampling frequency of 4Hz.
18 secondary outcomes
Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: baseline, pre-intervention
Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: up to 4 weeks
Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: up to 8 weeks
Gastrointestinal Symptom Score Questionnaire (GIS)
Time frame: baseline, pre-intervention
Gastrointestinal Symptom Score Questionnaire (GIS)
Time frame: up to 4 weeks
Gastrointestinal Symptom Score Questionnaire (GIS)
Time frame: up to 8 weeks
Nepean Dyspepsia Index (NDI)
Time frame: baseline, pre-intervention
Nepean Dyspepsia Index (NDI)
Time frame: up to 4 weeks
Nepean Dyspepsia Index (NDI)
Time frame: up to 8 weeks
Functional Dyspepsia Quality of Life questionnaire (FDQOL).
Time frame: baseline, pre-intervention
Functional Dyspepsia Quality of Life questionnaire (FDQOL).
Time frame: up to 4 weeks
Functional Dyspepsia Quality of Life questionnaire (FDQOL).
Time frame: up to 8 weeks
Gastrointestinal hormone level testing
Time frame: baseline, pre-intervention
Gastrointestinal hormone level testing
Time frame: up to 4 weeks
Intestinal microbiota diversity testing
Time frame: baseline, pre-intervention
Intestinal microbiota diversity testing
Time frame: up to 4 weeks
Intestinal microbiota metabolite testing
Time frame: baseline, pre-intervention
Intestinal microbiota metabolite testing
Time frame: up to 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Functional Dyspepsia
Active, not recruitingPhase 1
AutoSTEA for Adults With Functional Dyspepsia
Functional Dyspepsia
Recruiting
Probiotic and Ginger Supplement for Symptoms and Quality of Life in Functional Dyspepsia (SUBTILE)
Functional Dyspepsia
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
RecruitingPhase 4
Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia
Functional Dyspepsia, Probiotics
RecruitingPhase 2
Exploring Novel Therapeutic Approaches for Disorders of Gut-Liver-Brain Interaction-H1/H2
Functional Gastrointestinal Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Electro-acupuncture in people with Functional Dyspepsia, run by Wuhan Central Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Tang, PhD (13871235994, tanglei125716@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall efficacy evaluation (time frame: up to 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.