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

NCT ID: NCT04930146

Last Updated: 2021-06-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-08
• Study Completion Date: 2024-06-07

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.

Conditions

Traumatic Brain Injury (TBI)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group (Severe)

A patient's Glasgow Coma Score (GCS) between 5-8

1. 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.

2. Evaluating the meridian energy by M.E.A.D

Group Type: EXPERIMENTAL

acupuncture and bloodletting

Intervention Type: OTHER

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.

Control group (Severe)

A patient's Glasgow Coma Score (GCS) between 5-8

1. Conventional treatment.

2. Evaluating the meridian energy by M.E.A.D

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention group (Moderate)

A patient's Glasgow Coma Score (GCS) between 9-13

1. 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.

2. Evaluating the meridian energy by M.E.A.D

Group Type: EXPERIMENTAL

acupuncture and bloodletting

Intervention Type: OTHER

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.

Control group (moderate)

A patient's Glasgow Coma Score (GCS) between 9-13

1. Conventional treatment.

2. Evaluating the meridian energy by M.E.A.D

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

acupuncture and bloodletting

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

wei Ling Chou

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Medical Foundation

Locations

Chang Gung Memorial Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

wei Ling Chou

Role: CONTACT

wenni1207@cgmh.org.tw

+886 975360906

Facility Contacts

Wei Ling Chou

Role: primary

+886 975360906

Other Identifiers

202100683A3

Identifier Type: -

Identifier Source: org_study_id