Catamenial Epilepsy Treatment
Palavras-chave
Resumo
Descrição
It is known that the female hormone levels in epilepsy patients are different from healthy women. These hormonal differences may be part of the cause of catamenial epilepsy. It is estimated that at least 1 in every 3 women with epilepsy have catamenial epilepsy. Although many antiepileptic drugs are available, it is very difficult to control these seizures. In the past, studies using antiepileptic drugs and hormonal agents were done to treat catamenial epilepsy. However, those medications did not work well and caused side effects.
Keishibukuryogan is a traditional Japanese herbal medication. It is made of 5 natural herbs (cinnamon bark, hoelen, moutan bark, peony root, and peach kernel). It is used to treat disorders in women like menopause and menstrual cycle problems. This is the first study to examine the safety of Keishibukuryogan in women with epilepsy. As such, Keishibukuryogan and your current antiepileptic drug(s) will be given to you during the study.
Keishibukuryogan is a dietary supplement in the United States. It can be bought without a prescription. The safety and efficacy of Keishibukuryogan has not been studied in epilepsy. However, it has been used safely in Japan and other Asian countries for years.
datas
| Última verificação: | 01/31/2012 |
| Enviado pela primeira vez: | 02/15/2011 |
| Inscrição estimada enviada: | 02/16/2011 |
| Postado pela primeira vez: | 02/17/2011 |
| Última atualização enviada: | 02/12/2012 |
| Última atualização postada: | 02/13/2012 |
| Data real de início do estudo: | 01/31/2011 |
| Data Estimada de Conclusão Primária: | 11/30/2012 |
| Data Estimada de Conclusão do Estudo: | 11/30/2012 |
Condição ou doença
Intervenção / tratamento
Drug: AED treatment plus placebo
Drug: Keishibukuryogan
Fase
Grupos de Armas
| Braço | Intervenção / tratamento |
|---|---|
| Active Comparator: AED treatment plus placebo | Drug: AED treatment plus placebo Your usual AED(s) treatment with placebo for 12 weeks followed by 4 weeks washout period, and then Keishibukuryogan, (2.5 g of granulate filled in capsules) three times a day for a total of 7.5 g a day with your usual AED(s) treatment for 12 weeks. |
| Experimental: Keishibukuryogan | Drug: Keishibukuryogan Keishibukuryogan, (2.5 g of granulate filled in capsules) three times a day for a total of 7.5 g a day with your usual AED(s) for 12 weeks followed by 4 weeks washout period, and then your usual AED(s) treatment with placebo for 12 weeks. |
Critério de eleição
| Idades qualificadas para estudar | 21 Years Para 21 Years |
| Sexos elegíveis para estudo | Female |
| Aceita Voluntários Saudáveis | sim |
| Critério | Inclusion Criteria 1. Female with a positive diagnosis of epilepsy, and 2. Women with epilepsy (WWE) patients who have seizures and treated with AEDs and no dosage changes in the past 30 days, and 3. WWE patients with regular menstrual period with range of 28 ± 7 days. 4. WWE patients with age range between 21 and 45 years old. 5. WWE patients who are willing and able to give signed informed consent form are eligible to participate in this study. 6. WWE who agree to use non-hormonal forms of contraception for the duration of this study. No hormonal Intra-Uterine Device is allowed for the duration of this study. 7. Patients with a history of cancer must be in remission for at least 5 years. Exclusion Criteria 1. History of status epilepticus in the last 12 months 2. Current diagnosis of polycystic ovary syndrome and/or endometriosis 3. Pregnant or breast feeding 4. Allergy to any ingredients in KBG (cinnamon, hoelen, moutan bark, peony root, or peach kernel) 5. Patients who are receiving warfarin and/or antiplatelet drugs 6. Severe cardiovascular, renal or hepatic impairment (i.e., coronary heart disease, myocardial infarction, renal failure, hepatitis) or history of those diseases 7. Any other unstable diseases (e.g., mental disease, infection, cancer) 8. Lab values at screening phase showing 1.5 times above the upper range of normal 9. Patients who are receiving phenytoin will be excluded (since a potential interaction between phenytoin and peony root was reported) |
Resultado
Medidas de Resultado Primário
1. To determine if Keishibukuryogan is safe for WWE [up to 36 weeks]
Medidas de Resultado Secundário
1. To determine if KBG changes seizure frequency in WWE, with a focus on increases in seizure frequency. [up to 36 weeks]
2. To determine if KBG alters progesterone levels in WWE. [up to 36 weeks]
