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Traditional Chinese Medicine for Complications in Critically Ill Patients

Primary Purpose

Critically Ill Patients

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Chinese herbal medicine decoction、Acupuncture or Laser acupuncture pen treatment、Acupoint Tuina massage、Acupoint application、Nursing/Diet and health education and guidance
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critically Ill Patients focused on measuring Traditional Chinese Medicine, intensive care,

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • China Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention group

control group

Arm 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.

Nursing and health education and guidance Diet and health education

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 28, 2022
Last Updated
July 12, 2022
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05458687
Brief Title
Traditional Chinese Medicine for Complications in Critically Ill Patients
Official Title
Traditional Chinese Medicine for Complications in Critically Ill Patients: a Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2022 (Actual)
Primary Completion Date
June 20, 2023 (Anticipated)
Study Completion Date
June 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill Patients
Keywords
Traditional Chinese Medicine, intensive care,

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm 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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
Nursing and health education and guidance Diet and health education
Intervention Type
Other
Intervention Name(s)
Chinese herbal medicine decoction、Acupuncture or Laser acupuncture pen treatment、Acupoint Tuina massage、Acupoint application、Nursing/Diet and health education and guidance
Intervention Description
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.
Primary Outcome Measure Information:
Title
The main outcomes will be the incidence of arrhythmia, delirium, and poor digestion and the severity of pain.
Description
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.
Time Frame
ICDSC、RASS、BPS record by everyday.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-Chen Lee, Ph.D.
Phone
886-4-22052121
Ext
4564
Email
d5167@mail.cmuh.org.tw
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu-Chen Lee, Ph.D.
Phone
+886-975-682-023
Email
d5167@mail.cmuh.org.tw

12. IPD Sharing Statement

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Traditional Chinese Medicine for Complications in Critically Ill Patients

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