NCT05458687

Brief Summary

The purpose of this study was to examine the impact of Chinese medicine on common problems in intensive care units.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 21, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 14, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2023

Completed
Last Updated

July 14, 2022

Status Verified

July 1, 2022

Enrollment Period

12 months

First QC Date

June 28, 2022

Last Update Submit

July 12, 2022

Conditions

Keywords

Traditional Chinese Medicine, intensive care,

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.

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

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.

intervention group

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Yu-Chen Lee, Ph.D.

CONTACT

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

Locations