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Functional Recovery Effect of Bloodletting Puncture at Jing-well Points on Acute Brain Injury Patients

Primary Purpose

Traumatic Brain Injury (TBI)

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
acupuncture and bloodletting
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury (TBI) focused on measuring Traumatic brain injury, TBI, Bloodletting, acupuncture

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient with moderate to severe head injury are admitted to the ICU (Intensive Care Unit). patient with stable vital sign and the GCS (Glasgow coma volume) between 5-13 will be included.
  2. Patient with normal consciousness and no cognitive or motor function disease before brain injury.
  3. Patient aged between 20 to 80 years old and is willing to sign the consent (the agent can sign on behalf of patient).

Exclusion Criteria:

  1. Patients who are vital sign unstable and with severe complication.
  2. Patients combined with other terminal illness such as cancer in terminal stage, liver failure, end stage renal failure and so on.
  3. Pregnant patients.
  4. Any other conditions deemed unsuitable by the physician in charge.
  5. Patients (agent of the patient) who did not sign the consent.

Sites / Locations

  • Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

Intervention group (Severe)

Control group (Severe)

Intervention group (Moderate)

Control group (moderate)

Arm Description

A patient's Glasgow Coma Score (GCS) between 5-8 Conventional treatment and bloodletting at the well points of both hands and feet and acupuncture in DU26, DU24 3 times per week for 4 weeks, total 12 treatments. Evaluating the meridian energy by M.E.A.D

A patient's Glasgow Coma Score (GCS) between 5-8 Conventional treatment. Evaluating the meridian energy by M.E.A.D

A patient's Glasgow Coma Score (GCS) between 9-13 Conventional treatment and bloodletting at the well points of both hands and feet and acupuncture in DU26, DU24 3 times per week for 4 weeks, total 12 treatments. Evaluating the meridian energy by M.E.A.D

A patient's Glasgow Coma Score (GCS) between 9-13 Conventional treatment. Evaluating the meridian energy by M.E.A.D

Outcomes

Primary Outcome Measures

GCS(Glasgow Coma Scale)
To assess the recovery of consciousness. Lower GCS scores are correlated with higher risk of death.
Barthel index
To assess the activities of daily life.
Muscle power
To assess the recovery of muscle power.
mGOS(Modified Glasgow Outcome Score)
To assess the neurological outcomes, score 1 to 5. the higher the score, the better outcome.
RTS (Revised Trauma Score)
To assess the physiologic condition of patients. The Revised Trauma Score is made up of a three categories: Glasgow Coma Scale, systolic blood pressure, and respiratory rate. The score range is 0-12. A lower score indicates a higher severity of injury.

Secondary Outcome Measures

Meridian energy assessment
To assess meridian energy by Meridian Energy Analysis Device (M.E.A.D. )

Full Information

First Posted
June 9, 2021
Last Updated
June 16, 2021
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04930146
Brief Title
Functional Recovery Effect of Bloodletting Puncture at Jing-well Points on Acute Brain Injury Patients
Official Title
To Evaluate the Functional Recovery Effect of Bloodletting Puncture at Jing-well Points on Acute Brain Injury Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 8, 2021 (Actual)
Primary Completion Date
June 7, 2024 (Anticipated)
Study Completion Date
June 7, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Traumatic brain injury (Traumatic brain injury, TBI) can be derived from various forms of injury, including blunt trauma, penetrating or acceleration/deceleration force caused by head injury.There are some study data show that acupuncture treatment has a superficial effect on the prognosis of traumatic brain injury and can limit the progression of secondary brain injury, but the effect of early bloodletting at the Jing-points on TBI patients still unknown. In our study, the investigators have proposed a randomized, controlled study design and plan to evaluate the efficacy and safety of Jing-point puncture to improve consciousness and neurological function in patients with TBI. In addition, an objective meridian instrument analysis was added to analyze the energy distribution in the meridian of TBI patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury (TBI)
Keywords
Traumatic brain injury, TBI, Bloodletting, acupuncture

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Intervention group (Severe)
Arm Type
Experimental
Arm Description
A patient's Glasgow Coma Score (GCS) between 5-8 Conventional treatment and bloodletting at the well points of both hands and feet and acupuncture in DU26, DU24 3 times per week for 4 weeks, total 12 treatments. Evaluating the meridian energy by M.E.A.D
Arm Title
Control group (Severe)
Arm Type
No Intervention
Arm Description
A patient's Glasgow Coma Score (GCS) between 5-8 Conventional treatment. Evaluating the meridian energy by M.E.A.D
Arm Title
Intervention group (Moderate)
Arm Type
Experimental
Arm Description
A patient's Glasgow Coma Score (GCS) between 9-13 Conventional treatment and bloodletting at the well points of both hands and feet and acupuncture in DU26, DU24 3 times per week for 4 weeks, total 12 treatments. Evaluating the meridian energy by M.E.A.D
Arm Title
Control group (moderate)
Arm Type
No Intervention
Arm Description
A patient's Glasgow Coma Score (GCS) between 9-13 Conventional treatment. Evaluating the meridian energy by M.E.A.D
Intervention Type
Other
Intervention Name(s)
acupuncture and bloodletting
Intervention Description
bloodletting at the well points of both hands and feet and acupuncture in DU26, DU24 3 times per week for 4 weeks, total 12 treatments.
Primary Outcome Measure Information:
Title
GCS(Glasgow Coma Scale)
Description
To assess the recovery of consciousness. Lower GCS scores are correlated with higher risk of death.
Time Frame
4 weeks
Title
Barthel index
Description
To assess the activities of daily life.
Time Frame
4 weeks
Title
Muscle power
Description
To assess the recovery of muscle power.
Time Frame
4 weeks
Title
mGOS(Modified Glasgow Outcome Score)
Description
To assess the neurological outcomes, score 1 to 5. the higher the score, the better outcome.
Time Frame
4 weeks
Title
RTS (Revised Trauma Score)
Description
To assess the physiologic condition of patients. The Revised Trauma Score is made up of a three categories: Glasgow Coma Scale, systolic blood pressure, and respiratory rate. The score range is 0-12. A lower score indicates a higher severity of injury.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Meridian energy assessment
Description
To assess meridian energy by Meridian Energy Analysis Device (M.E.A.D. )
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with moderate to severe head injury are admitted to the ICU (Intensive Care Unit). patient with stable vital sign and the GCS (Glasgow coma volume) between 5-13 will be included. Patient with normal consciousness and no cognitive or motor function disease before brain injury. Patient aged between 20 to 80 years old and is willing to sign the consent (the agent can sign on behalf of patient). Exclusion Criteria: Patients who are vital sign unstable and with severe complication. Patients combined with other terminal illness such as cancer in terminal stage, liver failure, end stage renal failure and so on. Pregnant patients. Any other conditions deemed unsuitable by the physician in charge. Patients (agent of the patient) who did not sign the consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
wei Ling Chou
Phone
+886 975360906
Email
wenni1207@cgmh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
wei Ling Chou
Organizational Affiliation
Chang Gung Medical Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Ling Chou
Phone
+886 975360906
First Name & Middle Initial & Last Name & Degree
Wei Ling Chou

12. IPD Sharing Statement

Plan to Share IPD
No

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Functional Recovery Effect of Bloodletting Puncture at Jing-well Points on Acute Brain Injury Patients

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