Traditional Chinese Acupoint MessageNCT06207461
Traditional Chinese Acupoint Massage for Gastrointestinal Function Recovery
An observational study of Traditional Chinese Acupoint Message and Intestinal Barrier, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
Patients in the intensive care unit (ICU) are often at risk of gastrointestinal dysfunction and malnutrition. Gastrointestinal dysfunction was associated with poor clinical outcomes, including prolonged mechanical ventilation, prolonged ICU stay and increased 90-day mortality. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Traditional Chinese Acupoint Message, Intestinal Barrier, Gastrointestinal Dysfunction
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 1 Oct 2025
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult critically ill patients at high risk of malnutrition due to gastrointestinal functional impairment caused by medical diseases in the ICU, and AGI grade I-II or NRS 2002 score ≥3.
Who may be able to join
- Patients aged 18-80 years old without restriction of gender, race, religion, creed or nationality;
- Patients with high risk of malnutrition due to gastrointestinal dysfunction caused by medical diseases, and AGI score Ⅰ-Ⅱ or NRS 2002 score ≥3 points;
- Patients with hospital stay longer than 120 hours;
- Willing to participate in this trial.
Who cannot join
- Patients with abdominal open trauma;
- Defects, infections or lesions in the skin near the acupoints；
- Patients with abdominal tumor or large amount of abdominal fluid;
- Patients with AGI score Ⅲ or above;
- Pregnant patients;
- Patients with Child-Pugh grade B and grade C liver function
- Unable or unwilling to provide informed consent or poor compliance.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
About this study
Official title: Effects of Traditional Chinese Acupoint Massage on Gastrointestinal Function Recovery of ICU Patients: a Single-center, Prospective, Non-blind, Randomized Study
Patients in the intensive care unit (ICU) are often at risk of gastrointestinal dysfunction and malnutrition. Gastrointestinal dysfunction was associated with poor clinical outcomes, including prolonged mechanical ventilation, prolonged ICU stay and increased 90-day mortality.
There have been some clinical studies investigating the effects of traditional Chinese acupoint massage, acupuncture, or moxibustion of 7 acupoints (Zhongwan Point (CV12), Tianshu Point (ST25), Qihai Point (CV6), Zusanli point (ST36), Shangjuxu Point (ST37), Neiguan Point (PC6) and Hegu Point (LI4)) on gastrointestinal function recovery. Gastrointestinal dysfunction could be improved by stimulating single acupoint or combining multiple acupoints, and the effects of combined stimulation of multiple acupoints was better for the improvement of gastrointestinal dysfunction.
This project aims to study the effects of traditional Chinese acupoint massage, acupuncture, or moxibustion of 7 acupoints (Zhongwan Point (CV12), Tianshu Point (ST25), Qihai Point (CV6), Zusanli point (ST36), Shangjuxu Point (ST37), Neiguan Point (PC6) and Hegu Point (LI4)) on the 28-day survival, and the gastrointestinal function recovery in critically ill patients with with gastrointestinal dysfunction caused by medical diseases and critically ill patients with high risk of malnutrition in ICU, and to observe their effects on the recovery of gastrointestinal barrier function by measuring the serum intestinal fatty acid binding protein (iFABP), citrulline, diamine oxidase (DAO) and D-lactic acid. Studies have shown that serum iFABP, citrulline, DAO and D-lactic acid could reflect the intestinal barrier function of the patients.
- Keywords
- Acupoint massage, Gastrointestinal dysfunction, Gastrointestinal function recovery, Intensive care unit, Intestinal barrier
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| massage group | patients with gastrointestinal function injury caused by medical diseases or with high risk of malnutrition who got massage | |
| non-massage group | patients with gastrointestinal function injury caused by medical diseases or with high risk of malnutrition who got no massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day survival rate (%)
Survival at 28 days after hospitalization
Measured: Up to 4 weeks
Ultrasound assessment of gastrointestinal function: ACF (times/min)
Antral contraction frequency (ACF): In semi-recumbent position at 45°, infuse the stomach with 300ml of warm water. Within 6 minutes after infusion, divide the number of antral contractions by 3.
Measured: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Ultrasound assessment of gastrointestinal function: ACA (%)
Antral contraction amplitude (ACA): Measure the area during 3 maximum relaxations (S relaxation) and minimum contractions (S contraction), calculate the change in antral area (ΔS = S relaxation - S contraction), and take the average of 3 measurements. Antral contraction amplitude: ΔS/S relaxation.
Measured: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Ultrasound assessment of gastrointestinal function: MI
Motility index (MI): ACF × ACA.
Measured: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Ultrasound assessment of gastrointestinal function: GET (min)
Gastric emptying time (GET): In semi-recumbent position at 45°, infuse the stomach with 300ml of warm water. Use the maximum antral relaxation as the standard and measure the area every 5 minutes until the liquid in the antrum is emptied. The time it takes for the gastric antrum to empty is GET.
Measured: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Ultrasound assessment of gastrointestinal function: intestinal wall thickness (mm)
Intestinal wall thickness of Jejunum/Ileum/Colon: Refers to the distance between the serosal and mucosal surfaces of the intestinal wall. The normal thickness of the small intestine is 2-3mm, and >3mm may indicate thickening of the intestinal wall; the thickness of the colon wall is approximately 3-4mm, and >5mm may suggest thickening of the intestinal wall. Attention should be paid to the colon pocket and the plica structure on the colon wall.
Measured: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Ultrasound assessment of gastrointestinal function: intestinal diameter (cm)
Intestinal diameter of Jejunum/Ileum/Colon: When not under pressure, the measurement of the width of the small intestine often refers to the distance between the mucosal surfaces of the intestinal wall. The intestinal lumen width of the small intestine (jejunum/ileum) is generally <2cm, and >3cm may indicate intestinal dilation; the internal diameter of the colon is generally <5cm.
Measured: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Ultrasound assessment of gastrointestinal function: intestinal motility
Intestinal motility of Jejunum/Ileum/Colon (yes or no): Under normal circumstances, intestinal movement can be clearly judged at the ultrasound interface. When the intestine is filled with gas or accompanied by intestinal dilation, intestinal motility can be judged by the "creeping gas sign" of the gas or the movement of the contents. In addition, attention should be paid to the intestinal motility caused by the pressure on the intestinal tube when moving the probe.
Measured: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Secondary outcomes (30)
Daily amount of enteral nutrition feeding (ml)
Daily amount of enteral nutrition feeding
Measured: Within 5 days after study inclusion
Daily gastric residual volume (ml)
Daily gastric residual volume
Measured: Within 5 days after study inclusion
Serum levels of intestinal fatty acid binding protein (iFABP, ng/ml)
Serum levels of iFABP measured by ELISA.
Measured: 0, 72 and 120 hours after study inclusion
Serum levels of citrulline (μmol/L)
Serum levels of citrulline measured by ELISA.
Measured: 0, 72 and 120 hours after study inclusion
Serum levels of diamine oxidase (DAO, U/L)
Serum levels of DAO measured by ELISA.
Measured: 0, 72 and 120 hours after study inclusion
Serum levels of D-lactic acid (mmol/L)
Serum levels of D-lactic acid measured by ELISA.
Measured: 0, 72 and 120 hours after study inclusion
Superior mesenteric artery resistance index
Superior mesenteric artery resistance index evaluated by ultrasound
Measured: 0, 72 and 120 hours after study inclusion
Intra-abdominal pressure (IAP) (mmHg)
Intra-abdominal pressure (IAP)
Measured: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Diarrhea
Yes (numbers) or No
Measured: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Alimentary tract hemorrhage
Yes (numbers) or No
Measured: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Prealbumin concentration (g/L)
Serum levels of prealbumin
Measured: 0, 72 and 120 hours after study inclusion
Acute physiology and chronic health evaluation (APACHE) Ⅱ score
0-67, higher scores correspond to more severe disease and a higher risk of death
Measured: 0, 24, 48, 72, 96 and 120 hours after study inclusion
ICU length of stay (days)
ICU length of stay
Measured: Up to 4 weeks
In-hospital mortality (%)
Mortality rate during hospitalization
Measured: Up to 4 weeks
Peripheral venous blood CRP concentration (mg/L)
CRP level measured by blood routine examination
Measured: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Peripheral venous blood hemoglobin concentration (g/L)
Hemoglobin level measured by blood routine examination
Measured: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Absolute number of white blood cells in the peripheral venous blood (number/L)
Absolute number of white blood cells measured by blood routine examination
Measured: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Absolute number of platelets in the peripheral venous blood (number/L)
Absolute number of platelets measured by blood routine examination
Measured: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Absolute number of lymphocytes in the peripheral venous blood (number/L)
Absolute number of lymphocytes measured by blood routine examination
Measured: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Whole blood pH
Arterial pH measured by blood gas analysis
Measured: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Arterial PaO2 (mmHg)
Arterial PaO2 measured by blood gas analysis
Measured: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Arterial PaCO2 (mmHg)
Arterial PaCO2 measured by blood gas analysis
Measured: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Arterial bicarbonate (mmol/L)
Arterial bicarbonate measured by blood gas analysis
Measured: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Arterial lactic acid (mmol/L)
Arterial lactic acid measured by blood gas analysis
Measured: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Peripheral venous blood albumin concentration (g/L)
Albumin level measured by Blood biochemical examination
Measured: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Peripheral venous blood total bilirubin concentration (μmol/L)
Total bilirubin level measured by Blood biochemical examination
Measured: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Peripheral venous blood bound bilirubin concentration (μmol/L)
Bound bilirubin level measured by Blood biochemical examination
Measured: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Peripheral venous blood creatinine concentration (μmol/L)
Creatinine level measured by Blood biochemical examination
Measured: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Peripheral venous blood ALT concentration (U/L)
ALT level measured by Blood biochemical examination
Measured: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Peripheral venous blood AST concentration (U/L)
AST level measured by Blood biochemical examination
Measured: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Why it stopped: Medical ethics have yet to be passed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traditional Chinese Acupoint MessageStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiancheng Zhang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207461
- Sponsor's protocol ID
- ZJC202401
- Status last verified
- Sep 2024
- First submitted
- 3 Dec 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Traditional Chinese Acupoint Massage on Gastrointestinal Function Recovery of ICU Patients: a Single-center, Prospective, Non-blind, Randomized Study
- ClinicalTrials.gov ID
- NCT06207461
- Acronym / sponsor ID
- ZJC202401
- Keywords
- Acupoint massage, Gastrointestinal dysfunction, Gastrointestinal function recovery, Intensive care unit, Intestinal barrier
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Medical ethics have yet to be passed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 17 Jan 2024 (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.
Patients in the intensive care unit (ICU) are often at risk of gastrointestinal dysfunction and malnutrition. Gastrointestinal dysfunction was associated with poor clinical outcomes, including prolonged mechanical ventilation, prolonged ICU stay and increased 90-day mortality.
There have been some clinical studies investigating the effects of traditional Chinese acupoint massage, acupuncture, or moxibustion of 7 acupoints (Zhongwan Point (CV12), Tianshu Point (ST25), Qihai Point (CV6), Zusanli point (ST36), Shangjuxu Point (ST37), Neiguan Point (PC6) and Hegu Point (LI4)) on gastrointestinal function recovery. Gastrointestinal dysfunction could be improved by stimulating single acupoint or combining multiple acupoints, and the effects of combined stimulation of multiple acupoints was better for the improvement of gastrointestinal dysfunction.
This project aims to study the effects of traditional Chinese acupoint massage, acupuncture, or moxibustion of 7 acupoints (Zhongwan Point (CV12), Tianshu Point (ST25), Qihai Point (CV6), Zusanli point (ST36), Shangjuxu Point (ST37), Neiguan Point (PC6) and Hegu Point (LI4)) on the 28-day survival, and the gastrointestinal function recovery in critically ill patients with with gastrointestinal dysfunction caused by medical diseases and critically ill patients with high risk of malnutrition in ICU, and to observe their effects on the recovery of gastrointestinal barrier function by measuring the serum intestinal fatty acid binding protein (iFABP), citrulline, diamine oxidase (DAO) and D-lactic acid. Studies have shown that serum iFABP, citrulline, DAO and D-lactic acid could reflect the intestinal barrier function of the patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| massage group | – | –patients with gastrointestinal function injury caused by medical diseases or with high risk of malnutrition who got massage |
| non-massage group | – | –patients with gastrointestinal function injury caused by medical diseases or with high risk of malnutrition who got no massage |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult critically ill patients at high risk of malnutrition due to gastrointestinal functional impairment caused by medical diseases in the ICU, and AGI grade I-II or NRS 2002 score ≥3.
Key inclusion criteria (4 listed)
- Patients aged 18-80 years old without restriction of gender, race, religion, creed or nationality;
- Patients with high risk of malnutrition due to gastrointestinal dysfunction caused by medical diseases, and AGI score Ⅰ-Ⅱ or NRS 2002 score ≥3 points;
- Patients with hospital stay longer than 120 hours;
- Willing to participate in this trial.
Key exclusion criteria (7 listed)
- Patients with abdominal open trauma;
- Defects, infections or lesions in the skin near the acupoints；
- Patients with abdominal tumor or large amount of abdominal fluid;
- Patients with AGI score Ⅲ or above;
- Pregnant patients;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
28-day survival rate (%)
Time frame: Up to 4 weeks
Survival at 28 days after hospitalization
Ultrasound assessment of gastrointestinal function: ACF (times/min)
Time frame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Antral contraction frequency (ACF): In semi-recumbent position at 45°, infuse the stomach with 300ml of warm water. Within 6 minutes after infusion, divide the number of antral contractions by 3.
Ultrasound assessment of gastrointestinal function: ACA (%)
Time frame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Antral contraction amplitude (ACA): Measure the area during 3 maximum relaxations (S relaxation) and minimum contractions (S contraction), calculate the change in antral area (ΔS = S relaxation - S contraction), and take the average of 3 measurements. Antral contraction amplitude: ΔS/S relaxation.
Ultrasound assessment of gastrointestinal function: MI
Time frame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Motility index (MI): ACF × ACA.
Ultrasound assessment of gastrointestinal function: GET (min)
Time frame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Gastric emptying time (GET): In semi-recumbent position at 45°, infuse the stomach with 300ml of warm water. Use the maximum antral relaxation as the standard and measure the area every 5 minutes until the liquid in the antrum is emptied. The time it takes for the gastric antrum to empty is GET.
Ultrasound assessment of gastrointestinal function: intestinal wall thickness (mm)
Time frame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Intestinal wall thickness of Jejunum/Ileum/Colon: Refers to the distance between the serosal and mucosal surfaces of the intestinal wall. The normal thickness of the small intestine is 2-3mm, and >3mm may indicate thickening of the intestinal wall; the thickness of the colon wall is approximately 3-4mm, and >5mm may suggest thickening of the intestinal wall. Attention should be paid to the colon pocket and the plica structure on the colon wall.
Ultrasound assessment of gastrointestinal function: intestinal diameter (cm)
Time frame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Intestinal diameter of Jejunum/Ileum/Colon: When not under pressure, the measurement of the width of the small intestine often refers to the distance between the mucosal surfaces of the intestinal wall. The intestinal lumen width of the small intestine (jejunum/ileum) is generally <2cm, and >3cm may indicate intestinal dilation; the internal diameter of the colon is generally <5cm.
Ultrasound assessment of gastrointestinal function: intestinal motility
Time frame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Intestinal motility of Jejunum/Ileum/Colon (yes or no): Under normal circumstances, intestinal movement can be clearly judged at the ultrasound interface. When the intestine is filled with gas or accompanied by intestinal dilation, intestinal motility can be judged by the "creeping gas sign" of the gas or the movement of the contents. In addition, attention should be paid to the intestinal motility caused by the pressure on the intestinal tube when moving the probe.
30 secondary outcomes
Daily amount of enteral nutrition feeding (ml)
Time frame: Within 5 days after study inclusion
Daily gastric residual volume (ml)
Time frame: Within 5 days after study inclusion
Serum levels of intestinal fatty acid binding protein (iFABP, ng/ml)
Time frame: 0, 72 and 120 hours after study inclusion
Serum levels of citrulline (μmol/L)
Time frame: 0, 72 and 120 hours after study inclusion
Serum levels of diamine oxidase (DAO, U/L)
Time frame: 0, 72 and 120 hours after study inclusion
Serum levels of D-lactic acid (mmol/L)
Time frame: 0, 72 and 120 hours after study inclusion
Superior mesenteric artery resistance index
Time frame: 0, 72 and 120 hours after study inclusion
Intra-abdominal pressure (IAP) (mmHg)
Time frame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Diarrhea
Time frame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Alimentary tract hemorrhage
Time frame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Prealbumin concentration (g/L)
Time frame: 0, 72 and 120 hours after study inclusion
Acute physiology and chronic health evaluation (APACHE) Ⅱ score
Time frame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
ICU length of stay (days)
Time frame: Up to 4 weeks
In-hospital mortality (%)
Time frame: Up to 4 weeks
Peripheral venous blood CRP concentration (mg/L)
Time frame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Peripheral venous blood hemoglobin concentration (g/L)
Time frame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Absolute number of white blood cells in the peripheral venous blood (number/L)
Time frame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Absolute number of platelets in the peripheral venous blood (number/L)
Time frame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Absolute number of lymphocytes in the peripheral venous blood (number/L)
Time frame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Whole blood pH
Time frame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Arterial PaO2 (mmHg)
Time frame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Arterial PaCO2 (mmHg)
Time frame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Arterial bicarbonate (mmol/L)
Time frame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Arterial lactic acid (mmol/L)
Time frame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Peripheral venous blood albumin concentration (g/L)
Time frame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Peripheral venous blood total bilirubin concentration (μmol/L)
Time frame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Peripheral venous blood bound bilirubin concentration (μmol/L)
Time frame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Peripheral venous blood creatinine concentration (μmol/L)
Time frame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Peripheral venous blood ALT concentration (U/L)
Time frame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Peripheral venous blood AST concentration (U/L)
Time frame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traditional Chinese Acupoint Message and Intestinal Barrier, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
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 7 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: withdrawn, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day survival rate (%) (time frame: Up to 4 weeks). The study lists 8 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 19 Sep 2024; AzTrials last refreshed its copy on 6 Nov 2026.