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Study on the Mechanism and Therapeutic Effect of Ligustrazine on Alcohol Addiction

Clinical Study of Ligustrazine in Treating Alcohol Addiction

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072516
Enrollment
Unknown
Registered
2023-06-15
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol use disorder

Interventions

Conventional treatment + placebo group:Conventional treatment + placebo control (intravenous infusion of 250ml normal saline for 15 days, followed by starch analog tablets: once a day, 1 tablet each t
Conventional treatment + Ligustrazine short-term treatment:Ligustrazine Hydrochloride Injection: once a day, 40mg each time added to 250ml of normal saline intravenously for 15 days, followed by starc
Conventional treatment + ligustrazine maintenance treatment:After the short-term treatment of Ligustrazine, Ligustrazine Phosphate Tablets were continued: once a day, 50 mg each time, until the end of
Healthy control group:N/A

Sponsors

Shenzhen Kangning Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Case Inclusion Criteria 1) Alcohol addiction: ?Aged 18~65 years old; ? Meet the diagnostic criteria of DSM-IV alcohol dependence; ?No clear history of neurological diseases in the past, no family history of mental diseases; ?Voluntary participation in research, with good follow-up and observation, and good compliance; ? No obvious psychotic symptoms. 2) Combined with the treatment indications of ligustrazine, the selected cases must meet the arteriosclerosis index = 4: Inclusion criteria for normal subjects: ? Age, gender, and alcohol addiction cases matched; ? No history of continuous drinking, no substance dependence diagnosis, no drug use; ?No serious nervous system or mental disease; no experience of traumatic brain injury or other brain tissue damage; ? Not taking any psychotropic drugs in a short period of time; ? No cognitive dysfunction.

Exclusion criteria

Exclusion criteria: Case Exclusion Criteria ? Acute alcohol withdrawal phase, CIWA-Ar > 9 points; ? Severe neurological or mental illnesses caused by diseases other than chronic alcohol dependence: such asStroke, intracranial infection, brain tumor, schizophrenia, etc.; ? Have experienced a traumatic brain injury or other damage to brain tissue; ? Taking any other psychotropic drugs, drug use, or other substance dependence in the short term; ? There are contraindications to the application of ligustrazine, or women are pregnant and other conditions that are not suitable for drug use; ? There are conditions that are not suitable for head MRI examination, such as claustrophobia, metal objects in the body, etc. Exclusion criteria for normal subjects: ?Routine physical examination (physical examination, blood test, electrocardiogram) shows prominent physical diseases; ? There are conditions that are not suitable for head MRI examination, such as claustrophobia, metal objects in the body, etc.

Design outcomes

Primary

MeasureTime frame
Relapse rate (alcohol relapse);

Secondary

MeasureTime frame
Time to maintain abstinence (days);Frequency and amount of alcohol consumed;

Countries

China

Contacts

Public ContactJia Xiaojian

Shenzhen Kangning Hospital

94205638@qq.com+86 138 2379 7115

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026