epilepsy
Conditions
Interventions
patients with epilepsy (PWE):Traditional Chinese Medicine (TCM) compounds
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1) meet the diagnostic criteria of TCM and western medicine for epilepsy Diagnostic criteria of western medicine Epilepsy was diagnosed according to the ILAE 2014 criteria: at least two unprovoked (or reflex) seizures with an interval of more than 24 hours; 1 unprovoked (or reflex) seizure with a likelihood of having another seizure similar to the general risk after two unprovoked seizures over the next 10 years (at least 60%). TCM diagnostic criteria The diagnosis of epilepsy was determined according to the Establishment of the Data Set of the Standard of Diagnosis and Treatment of Traditional Chinese and Western Medicine for Epilepsy (2023) and the Diagnostic Efficacy Criteria of TCM Syndromes (1994). The classification of syndrome types was based on Traditional Chinese Medicine Internal Science (Wu Mianhua Shi Yan China Traditional Chinese Medicine Press 11th edition). 2) Age of 18-60 years old male or female 3) the number of seizures was clear and countable; 4) seizure frequency =1 per 4 weeks during the 8 weeks before baseline; 5) had to be on a stable antiepileptic medication for at least 4 weeks before baseline and be willing to maintain a stable antiepileptic medication regimen throughout the study; 6) Able to complete the epilepsy diary independently or with the help of family members and cooperate with the collection of relevant clinical data and clinical examination process; 7) All subjects agreed to the treatment and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1) lactating women pregnant women and women of childbearing age who did not agree to take effective contraceptive measures during the study period 2) The presence of progressive organic diseases of the central nervous system such as cerebrovascular diseases brain tumors and rapidly progressive cognitive impairment 3) patients with a history of psychogenic non-epileptic seizures 4) Persistent mental illness or any other medical condition or mental illness that the investigator believes may affect participation in the study (17-item Hamilton Depression Scale (HAMD-17) =17 14-item Hamilton Anxiety Scale (HAMA-14) =14) 5) other difficult to control clinical problems (such as cancer HIV infection syphilis infection hepatitis C virus infection active hepatitis B or other serious chronic infectious diseases serious neurological cardiovascular respiratory and other system diseases); 6) impaired renal function (blood Cr > 1.5×ULN) or abnormal liver function (ALT or AST > 2×ULN) 7) taking TCM within 2 weeks before baseline 8) participants who participated in other drug clinical trials 2 weeks before baseline 9) severe intellectual impairment visual impairment hearing impairment and other inability to cooperate or poor compliance 10) cannot agree to take TCM treatment 11) those who were considered by the investigator to be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seizure frequency; | — |
Secondary
| Measure | Time frame |
|---|---|
| Seizure severity;cognitive function;Anxiety and depression score;Seizure duration; | — |
Countries
China
Contacts
Public ContactLei Chen
West China Hospital of Sichuan University
Outcome results
None listed