EVALUATE THE EFFECT OF KUSHMANDA GHRITA IN TREATING SEIZURES

EFFICACY OF KUSHMANDA GHRITA AS AN ADD ON DRUG IN GENERALIZED TONIC CLONIC SEIZURES - A RANDOMIZED CONTROLLED CLINICAL TRIAL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/09/027749

Enrollment

Registered

2020-09-11

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Health Condition 1: G00-G99- Diseases of the nervous system

Interventions

Intervention1: KUSHMANDA GHRITA: Kushmanda ghrita 10ml BD after food for 90 days in patients already under Levetiracetam 500mg BD Control Intervention1: PLACEBO: Placebo 500 mg BD After food for 90

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
1.Chalfont-National Hospital seizure severity scale (NHS3) 2.Quality of Life in Epilepsy Inventory (QOLIE-31) 3.Changes in EEG before and after studyTimepoint: 30th day, 60th day & 90th day	—

Secondary

Measure	Time frame
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	—

Countries

India

Contacts

Public ContactDr BASAVARAJ R TUBAKI

KAHERs SHRI BM KANKANWADI AYURVEDA MAHAVIDYALAYA

ayurbasavaraj@gmail.com9448634660

Outcome results

None listed

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