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

Traumatic Brain Injury (TBI) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04930146
• Other study ID #: 202100683A3
• Status: Recruiting
• Phase: N/A
• Start date: June 8, 2021
• Est. completion date: June 7, 2024

Study information

• Verified date: June 2021
• Source: Chang Gung Memorial Hospital
• Contact: wei Ling Chou
• Phone: +886 975360906
• Email: wenni1207[@]cgmh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: June 7, 2024
• Est. primary completion date: June 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury (TBI)
• Wounds and Injuries

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GCS(Glasgow Coma Scale)	To assess the recovery of consciousness. Lower GCS scores are correlated with higher risk of death.	4 weeks
Primary	Barthel index	To assess the activities of daily life.	4 weeks
Primary	Muscle power	To assess the recovery of muscle power.	4 weeks
Primary	mGOS(Modified Glasgow Outcome Score)	To assess the neurological outcomes, score 1 to 5. the higher the score, the better outcome.	4 weeks
Primary	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.	4 weeks
Secondary	Meridian energy assessment	To assess meridian energy by Meridian Energy Analysis Device (M.E.A.D. )	4 weeks