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Chaibei Zhixian Decoction for Complex Partial Seizure of Intractable Epilepsy: a Randomized, Double-blind, Placebo-controlled trial

Chaibei Zhixian Decoction for Complex Partial Seizure of Intractable Epilepsy : a Randomized, Double-blind, Placebo-controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-16008775
Enrollment
Unknown
Registered
2016-07-04
Start date
2016-07-15
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

epilepsy

Interventions

treatment group:Standardized treatment +Chaibei Zhixian Decoction
control group:Standardized treatment +placebo

Sponsors

The Third Affiliated Hospital, Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for intractable epilepsy; 2. meet the criteria of complex partial seizure; 3. chronic disease of traditional Chinese medicine diagnosis standard and nitrogen stasis syndrome differentiation standard; 4. Aged 18 to 65 years old, men and women not limited; 5. before the screening visit, taking more than one stable first-line antiepileptics for at least 10 weeks; 6. no progressive neurological disease or brain tumor; 7. patients signed informed consent; 8. Around 4 retrospective baseline period at least 3-4 times complex partial seizure, patients with epilepsy must have a complete medical record review by diary.

Exclusion criteria

Exclusion criteria: 1. To be suitable for surgical indications and willing to try surgery; 2. with cardiovascular, liver, kidney and blood system, endocrine system and other severe primary and secondary diseases; 3. all kinds of nerve mental illness: schizophrenia and severe mood disorders, personality disorders, other nervous system caused by organic disease of mental disorder; To be confirmed the diagnosis of hysteria; 4. with aphasia Agnosia or other neurologic deficits symptoms can't cooperate with the investigators; 5. At the same time take part in other drug clinical study; 6. Taking other traditional Chinese medicine (TCM); 7. without standardized antiepileptic drug treatment of intractable epilepsy patients; 8. pregnancy, nursing mothers, or may be pregnancy in research; 9. baseline period abnormal laboratory indexes, such as SGPT and SGOT or alkaline phosphatase index 3 times beyond the normal limits, serum creatinine > 177 umol/L, white blood cell count < 2800/ul, etc.; 10. has a history of alcohol or other drug addiction or abuse history.

Design outcomes

Primary

MeasureTime frame
Total effective rate;

Secondary

MeasureTime frame
Electroencephalogram;

Countries

China

Contacts

Public ContactLiu Jinmin

The Third Affiliated Hospital, Beijing University of Chinese Medicine

jmvip@vip.163.com+86 13701179355

Outcome results

None listed

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