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Traditional Chinese Medicine for Complications in Critically Ill Patients

C

China Medical University

Status

Enrolling

Conditions

Critically Ill Patients

Treatments

Other: Chinese herbal medicine decoction、Acupuncture or Laser acupuncture pen treatment、Acupoint Tuina massage、Acupoint application、Nursing/Diet and health education and guidance

Study type

Interventional

Funder types

Other

Identifiers

NCT05458687
CMUH111-REC3-064

Details and patient eligibility

About

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

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

20 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age 20-90
  • newly intensive care unit admission (<48 hours)
  • Two or less inotropic medicine prescribed

Exclusion criteria

  • Clinically unstable: receiving more than inotropic agents.
  • Coagulopathy: Prolong Prothrombin Time、activated Partial Thromboplastin Time more than 4 times

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

intervention group
Experimental group
Description:
* 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.
Treatment:
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 group
Description:
* Nursing and health education and guidance * Diet and health education

Trial contacts and locations

1

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Central trial contact

Yu-Chen Lee, Ph.D.

Data sourced from clinicaltrials.gov

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