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

Chang Gung Medical Foundation

Status: Enrolling

Conditions: Traumatic Brain Injury (TBI)

Treatments: Other: acupuncture and bloodletting

Study type: Interventional

Funder types: Other

Identifiers

NCT04930146

202100683A3

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 4 patient groups

Intervention group (Severe)

Experimental group

Description:

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

Treatment:

Other: acupuncture and bloodletting

Control group (Severe)

No Intervention group

Description:

A patient's Glasgow Coma Score (GCS) between 5-8 1. Conventional treatment. 2. Evaluating the meridian energy by M.E.A.D

Intervention group (Moderate)

Experimental group

Description:

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

Treatment:

Other: acupuncture and bloodletting

Control group (moderate)

No Intervention group

Description:

A patient's Glasgow Coma Score (GCS) between 9-13 1. Conventional treatment. 2. Evaluating the meridian energy by M.E.A.D