EFFICACY OF KUSHMANDA GHRITA AS AN ADD ON DRUG INGENERALIZED TONIC CLONIC SEIZURES - A RANDOMIZEDCONTROLLED CLINICAL TRIAL
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1.Chalfont-National Hospital seizure severity scale (NHS3)
研究概览
简要总结
Apasmara is defined as Apagama of Smrti associated with Tamah Pravesha, and Bibhatsa Chesta due to derangement of Dhi and Satva .Generalized tonic–clonic seizure is bilateral symmetric or sometimes asymmetric tonic contraction and then bilateral clonic contraction of somatic muscles, usually associated with autonomic phenomena and loss of awareness. These seizures engage networks in both hemispheres at the start of the seizure.
Kushmaanda ghrita is one of the simple formulations described in Ashtanga Hridaya ,Uttarasthana, apasmara pratishedha and is widely practiced by Ayurvedic physicians as an alternative or complimentary therapy along with AED in their clinical settings. Kushmanda Ghrita has wide therapeutic activity like Deepana, Pachana, Akshepakahara, Sanjnasthapaka, Sroto Shodhaka, Smrti Vardhaka, Balya, Rasayana, Medhya etc. Hence it can have a potential role in the comprehensive management of Epilepsy.
Initialy patients diagnosed with Generalized tonic clonic seizures are screened according to the inclusion and exclusion criteria .Selected patients will be randomly divided into Group A(20 patients )and Group B(20 patients) .Group A is given with Kushmanda ghrita 10ml BD after food and Group B with placebo capsules 500 mg BD for 90 days.Both group are under AED(levetiracetam 500mg BD) .
Follow up will be done on 0th, 30th day, 60th day & 90th day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Those with an established diagnosis of Epilepsy with generalized tonic-clonic seizures
- •Patients having occurrence of at least one seizure during previous three months
- •18 to 60 years of age irrespective of gender and socio-economic status.
- •Patients having regular treatment since last 6 months and with Levetiracetam without adjustments to medication for past 3 months.
排除标准
- •Recent history of alcoholism and drug abuse.
- •Patients with uncontrolled diabetes mellitus, hypertension, congenital abnormalities, hepatic, renal, cardiac or endocrine disease.
- •Mental retardation, infectious diseases of brain, vascular causes, toxic causes and metabolic causes of seizures.
- •Episode of status epilepticus within the past 3 months.
- •Psychiatric disorders like Schizophrenia, Psychosis, depression, suicidal thoughts etc
- •Pregnancy and lactating mother.
结局指标
主要结局
1.Chalfont-National Hospital seizure severity scale (NHS3)
时间窗: 30th day, 60th day & 90th day
2.Quality of Life in Epilepsy Inventory (QOLIE-31)
时间窗: 30th day, 60th day & 90th day
3.Changes in EEG before and after study
时间窗: 30th day, 60th day & 90th day
次要结局
- Hamilton Anxiety Rating Scale(30th day, 60th day & 90th day)
- Hamilton Depression Rating Scale(30th day, 60th day & 90th day)
- The Pittsburgh Sleep Quality Index(30th day, 60th day & 90th day)
- Columbia Suicide Severity Rating Scale(30th day, 60th day & 90th day)
- Adverse event scales- UKU Scale(30th day, 60th day & 90th day)