Critically Ill PatientsNCT05458687
Traditional Chinese Medicine for Complications in Critically Ill Patients
A study testing Chinese herbal medicine decoction、Acupuncture or Laser acupuncture pen treatment、Acupoint Tuina massage、Acupoint application、Nursing/Diet and health education and guidance in people with Critically Ill Patients, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study was to examine the impact of Chinese medicine on common problems in intensive care units. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Critically Ill Patients
- What is being tested?
- Chinese herbal medicine decoction、Acupuncture or Laser acupuncture pen treatment、Acupoint Tuina massage、Acupoint application、Nursing/Diet and health education and guidance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Jun 2022to 20 Jun 2023
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20-90
- newly intensive care unit admission (<48 hours)
- Two or less inotropic medicine prescribed
Who cannot join
- Clinically unstable: receiving more than inotropic agents.
- Coagulopathy: Prolong Prothrombin Time、activated Partial Thromboplastin Time more than 4 times
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, 404
Yu-Chen Lee, Ph.D., +886-975-682-023, d5167@mail.cmuh.org.tw
About this study
Official title: Traditional Chinese Medicine for Complications in Critically Ill Patients: a Randomized Control Trial
The purpose of this study was to examine the impact of Chinese medicine on common problems in intensive care units.
Read the detailed description
Introduction: Intensive care unit is a special department in the health care facility. Although with highly development of modern medicine nowadays, the average mortality rate in Intensive care unit is still around 7 to 20 %. There are a few tricky problems that intensivists and intensive care nurses faced very often, including intensive care unit delirium, arrythmia and poor digestion problem that will all affect the mortality and morbidity rate of critical care patients. Traditional Chinese Medicine can possibly provide a series of interventions that can alleviate those conditions.
Methods: A randomized control trial will examine the effect of traditional Chinese Medicine interventions vs. routine intensive care unit care. The patients will be randomly divided 1:1 into one of two groups. A total of 80 intensive care patient will have to meet the following criteria: age 20-90, two or less inotropic medicine use. Interventions such as: Chinese herbal medicine decoction, acupuncture, laser acupuncture, Chinese Tuina massage, herbal medicinal cake applied on acupoint, health education and diet education, will be given based on the patients needs and Traditional Chinese Medicine doctor decision. The main outcomes will be the incidence of arrythmia, delirium, and poor digestion and the severity of pain. The investigators will also record intensive care unit mortality, intensive care unit stays and hospital days.
- Conditions
- Critically Ill Patients
- Being tested
- Chinese herbal medicine decoction、Acupuncture or Laser acupuncture pen treatment、Acupoint Tuina massage、Acupoint application、Nursing/Diet and health education and guidance
- Keywords
- Traditional Chinese Medicine, intensive care,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese herbal medicine decoction、Acupuncture or Laser acupuncture pen treatment、Acupoint Tuina massage、Acupoint application、Nursing/Diet and health education and guidanceOther
- Chinese herbal medicine decoction: prescribed three times a day, seven days a week, and lasts for up to one weeks.
- Acupuncture or Laser acupuncture pen treatment: twice a week, once for 20 minutes,up to a total of one week.
- Acupoint Tuina massage: once a day for up to 20 minutes each time, for up to a week.
- Acupoint application of traditional Chinese herbal medicinal cake: Apply warm navel ointment in our hospital to CV 4 (Guanyuan) point every day, and remove after getting up the next day, seven days a week for up to one week.
- Nursing and health education and guidance: teach the patients and their family members the matters needing attention in daily life.
- Diet and health education:give personalized Traditional Chinese Medicine diet guidance and recommendations in accordance with Traditional Chinese Medicine physique syndrome.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | * Chinese herbal medicine decoction.
* Acupuncture or Laser acupuncture pen treatment.
* Acupoint Tuina massage.
* Acupoint application of traditional Chinese herbal medicinal cake.
* Nursing and health education and guidance.
* Diet and health education. Receives: Other: Chinese herbal medicine decoction、Acupuncture or Laser acupuncture pen treatment、Acupoint Tuina massage、Acupoint application、Nursing/Diet and health education and guidance |
| control group | No intervention | * Nursing and health education and guidance * Diet and health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main outcomes will be the incidence of arrhythmia, delirium, and poor digestion and the severity of pain.
For delirium use the Intensive Care Delirium Screening Checklist (ICDSC) score of:0~8.
And Richmond Agitation-Sedation Scale (RASS) score of: -5~+4. For pain use the Behavioral pain scale(BPS) score of:3~12.
Measured: ICDSC、RASS、BPS record by everyday.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start21 Jun 2022
- Primary completion20 Jun 2023 (estimated)
- Study completion20 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically Ill PatientsStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458687
- Sponsor's protocol ID
- CMUH111-REC3-064
- Status last verified
- Jul 2022
- First submitted
- 28 Jun 2022
- Last updated
- 14 Jul 2022
- 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 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional Chinese Medicine for Complications in Critically Ill Patients: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05458687
- Acronym / sponsor ID
- CMUH111-REC3-064
- Conditions
- Critically Ill Patients
- Keywords
- Traditional Chinese Medicine, intensive care,
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 20 Jun 2023 (estimated)
- Study completion
- 20 Jun 2023 (estimated)
- First posted
- 14 Jul 2022 (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 purpose of this study was to examine the impact of Chinese medicine on common problems in intensive care units.
Detailed description
Introduction: Intensive care unit is a special department in the health care facility. Although with highly development of modern medicine nowadays, the average mortality rate in Intensive care unit is still around 7 to 20 %. There are a few tricky problems that intensivists and intensive care nurses faced very often, including intensive care unit delirium, arrythmia and poor digestion problem that will all affect the mortality and morbidity rate of critical care patients. Traditional Chinese Medicine can possibly provide a series of interventions that can alleviate those conditions.
Methods: A randomized control trial will examine the effect of traditional Chinese Medicine interventions vs. routine intensive care unit care. The patients will be randomly divided 1:1 into one of two groups. A total of 80 intensive care patient will have to meet the following criteria: age 20-90, two or less inotropic medicine use. Interventions such as: Chinese herbal medicine decoction, acupuncture, laser acupuncture, Chinese Tuina massage, herbal medicinal cake applied on acupoint, health education and diet education, will be given based on the patients needs and Traditional Chinese Medicine doctor decision. The main outcomes will be the incidence of arrythmia, delirium, and poor digestion and the severity of pain. The investigators will also record intensive care unit mortality, intensive care unit stays and hospital days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Chinese herbal medicine decoction、Acupuncture or Laser acupuncture pen treatment、Acupoint Tuina massage、Acupoint application、Nursing/Diet and health education and guidance* Chinese herbal medicine decoction. * Acupuncture or Laser acupuncture pen treatment. * Acupoint Tuina massage. * Acupoint application of traditional Chinese herbal medicinal cake. * Nursing and health education and guidance. * Diet and health education. |
| control group | No intervention | –* Nursing and health education and guidance * Diet and health education |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 20-90
- newly intensive care unit admission (<48 hours)
- Two or less inotropic medicine prescribed
Key exclusion criteria (2 listed)
- Clinically unstable: receiving more than inotropic agents.
- Coagulopathy: Prolong Prothrombin Time、activated Partial Thromboplastin Time more than 4 times
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 |
|---|---|---|
| Chinese herbal medicine decoction、Acupuncture or Laser acupuncture pen treatment、Acupoint Tuina massage、Acupoint application、Nursing/Diet and health education and guidance* Chinese herbal medicine decoction: prescribed three times a day, seven days a week, and lasts for up to one weeks. * Acupuncture or Laser acupuncture pen treatment: twice a week, once for 20 minutes,up to a total of one week. * Acupoint Tuina massage: once a day for up to 20 minutes each time, for up to a week. * Acupoint application of traditional Chinese herbal medicinal cake: Apply warm navel ointment in our hospital to CV 4 (Guanyuan) point every day, and remove after getting up the next day, seven days a week for up to one week. * Nursing and health education and guidance: teach the patients and their family members the matters needing attention in daily life. * Diet and health education:give personalized Traditional Chinese Medicine diet guidance and recommendations in accordance with Traditional Chinese Medicine physique syndrome. | Other | intervention group |
Primary outcome
The main outcomes will be the incidence of arrhythmia, delirium, and poor digestion and the severity of pain.
Time frame: ICDSC、RASS、BPS record by everyday.
For delirium use the Intensive Care Delirium Screening Checklist (ICDSC) score of:0~8. And Richmond Agitation-Sedation Scale (RASS) score of: -5~+4. For pain use the Behavioral pain scale(BPS) score of:3~12.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chinese herbal medicine decoction、Acupuncture or Laser acupuncture pen treatment、Acupoint Tuina massage、Acupoint application、Nursing/Diet and health education and guidance in people with Critically Ill Patients, run by China Medical University Hospital at 1 site in Taiwan.
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 3 inclusion and 2 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 14 Jul 2022. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Chen Lee, Ph.D. (886-4-22052121 ext. 4564, d5167@mail.cmuh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main outcomes will be the incidence of arrhythmia, delirium, and poor digestion and the severity of pain. (time frame: ICDSC、RASS、BPS record by everyday.). 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 14 Jul 2022.