Alcohol dependence
Conditions
Interventions
Sponsors
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) The age ranged from 18 to 65 years old; (2) It met the diagnostic criteria of dsm-5 and ICD-10 for alcohol dependence; (3) There was no obvious withdrawal symptoms, and the score of clinical alcohol withdrawal status rating scale (CIWA AR) was less than 15; (4) The score of the Michigan Alcohol Dependence Questionnaire (MAST) was > 7; (5) Voluntary participation and signing of informed consent form.
Exclusion criteria
Exclusion criteria: (1) There are progressive neurodegenerative diseases or clinically significant neurological diseases such as seizures; (2) They were taking antipsychotics, antiepileptics, mood stabilizers, carbonic anhydrase inhibitors, opioid analgesics or systemic steroids (drug washout period is allowed, depending on the pharmacokinetic characteristics of the drug); (3) Drug use disorder identification test (dudit) score > 6 (male), 2 (female), and meet the ICD-10 standard of substance dependence (except nicotine and caffeine); (4) Three months before admission, they received psychotherapy for mental disorders (non-alcoholic dependence); (5) Have tried more than 4 times of unsuccessful abstinence hospitalization treatment; (6) Although they met the diagnostic criteria of alcohol dependence, they were completely abstinent for more than 2 months; (7) Those who are allergic to Anshen prescription; (8) Pregnant women or those who plan to be pregnant within 3 months and lactating women; (9) Patients with severe physical diseases, including uncontrolled hypertension, cerebrovascular disease, pulmonary disease, thyroid disease, etc. (uncontrolled hypertension (systolic blood pressure > 180 mmHg, diastolic blood pressure > 110 mmHg)); (10) Those who are preparing for surgery or organ transplantation in the near future; (11) Those who can not carry out the test as required; (12) Patients with severe heart, liver, renal insufficiency or other serious laboratory abnormalities (cardiac problems defined as decompensated heart failure (NYHA grade III or IV), unstable angina pectoris and / or myocardial infarction in the past 12 months; liver function impairment (liver transaminase > 3 times the upper limit of normal); renal function impairment (estimated glomerular filtration rate (EGFR)) < 60ml /Keywords min; renal calculi; pancreatitis, etc.); (13) Participants in other drug trials in the past 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in average daily alcohol consumption during the week before and after treatment;Comparison of scores of self - rating scale of psychological craving during treatment;Evaluation of the effect of TCM syndromes; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of SF-36 score before and after treatment;Withdrawal rate during follow-up period;Comparison of mean abstinence time during follow-up period; | — |
Countries
China
Contacts
Public ContactXiaoyu Hu
Clinical School of Medicine, Chengdu University of Chinese Medicine
Outcome results
None listed