Traditional Chinese Medicine for Complications in Critically Ill Patients
1 other identifier
interventional
80
1 country
1
Brief Summary
The purpose of this study was to examine the impact of Chinese medicine on common problems in intensive care units.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 21, 2022
CompletedFirst Submitted
Initial submission to the registry
June 28, 2022
CompletedFirst Posted
Study publicly available on registry
July 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2023
CompletedJuly 14, 2022
July 1, 2022
12 months
June 28, 2022
July 12, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
ICDSC、RASS、BPS record by everyday.
Study Arms (2)
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.
control group
NO INTERVENTION* Nursing and health education and guidance * Diet and health education
Interventions
* 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.
Eligibility Criteria
You may qualify if:
- Age 20-90
- newly intensive care unit admission (\<48 hours)
- Two or less inotropic medicine prescribed
You may not qualify if:
- Clinically unstable: receiving more than inotropic agents.
- Coagulopathy: Prolong Prothrombin Time、activated Partial Thromboplastin Time more than 4 times
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China Medical University Hospital
Taichung, 404, Taiwan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2022
First Posted
July 14, 2022
Study Start
June 21, 2022
Primary Completion
June 20, 2023
Study Completion
June 20, 2023
Last Updated
July 14, 2022
Record last verified: 2022-07