EVALUATE THE EFFECT OF KUSHMANDA GHRITA IN TREATING SEIZURES
- Conditions
- Health Condition 1: G00-G99- Diseases of the nervous system
- Registration Number
- CTRI/2020/09/027749
- Lead Sponsor
- KLE UNIVERSITY
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
1.Those with an established diagnosis of Epilepsy with generalized tonic-clonic seizures
2. Patients having occurrence of at least one seizure during previous three months
3. 18 to 60 years of age irrespective of gender and socio-economic status.
4. Patients having regular treatment since last 6 months and with Levetiracetam without
adjustments to medication for past 3 months.
1. Recent history of alcoholism and drug abuse.
2. Patients with uncontrolled diabetes mellitus, hypertension, congenital abnormalities, hepatic,
renal, cardiac or endocrine disease.
3. Mental retardation, infectious diseases of brain, vascular causes, toxic causes and metabolic causes of seizures.
4. Episode of status epilepticus within the past 3 months.
5. Psychiatric disorders like Schizophrenia, Psychosis, depression, suicidal thoughts etc
6. Pregnancy and lactating mother.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Chalfont-National Hospital seizure severity scale (NHS3) <br/ ><br>2.Quality of Life in Epilepsy Inventory (QOLIE-31) <br/ ><br>3.Changes in EEG before and after studyTimepoint: 30th day, 60th day & 90th day
- Secondary Outcome Measures
Name Time Method Adverse event scales- UKU ScaleTimepoint: 30th day, 60th day & 90th day;Columbia Suicide Severity Rating ScaleTimepoint: 30th day, 60th day & 90th day;Hamilton Anxiety Rating ScaleTimepoint: 30th day, 60th day & 90th day;Hamilton Depression Rating ScaleTimepoint: 30th day, 60th day & 90th day;The Pittsburgh Sleep Quality IndexTimepoint: 30th day, 60th day & 90th day