Ayurvedic management of Epilepsy in children

Evaluation of comparative efficacy of Valproic acid alone Versus Valproic acid along with combination of Amruthadya tail Matra Vasti and Vacha-Shampakadi ghritha for the management of Apasmara (epilepsy) in children: A Randomised single-blind superiority clinical study

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/03/050961

Enrollment

128

Registered

2023-03-22

Start date

Unknown

Completion date

Unknown

Last updated

2023-04-03

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

Conditions

Health Condition 1: G409- Epilepsy, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children aged between 1 to 16 years diagnosed with epilepsy With ongoing medication of Valproic acid and having more than 2 episodes in the past 3 months will be included in the present study irrespective of types of epilepsy will be included for the present study

Exclusion criteria

Exclusion criteria: 1. Childhood epilepsy with acute seizures, multiple seizures >3/day, status epileptics, and associated with any neurodegenerative disorders like SSPE, NCL, Ataxic ataxia telangiectasia, MND will be excluded from the study

Design outcomes

Primary

Measure	Time frame
If Ayurvedic interventions along with antiepileptic drugs in the management of epilepsy found to be more efficacious then the same treatment plan will be studied in the management febrile complex seizures, neonatal seizures and all other seizure disordersTimepoint: Subjective parameters will be assessed on Day 1 (before treatment), day 30, 60th day, 90th day and 180th) day (after follow up). EEG before treatment (day 1 to past 3 months reports) and after follow up (3 months)	—

Measure

Time frame

If Ayurvedic interventions along with antiepileptic drugs in the management of epilepsy found to be more efficacious then the same treatment plan will be studied in the management febrile complex seizures, neonatal seizures and all other seizure disordersTimepoint: Subjective parameters will be assessed on Day 1 (before treatment), day 30, 60th day, 90th day and 180th) day (after follow up). EEG before treatment (day 1 to past 3 months reports) and after follow up (3 months)

—

Secondary

Measure	Time frame
COGNITIVE SKILLS WILL BE ASSESSED AS SECONDARY OUTCOMETimepoint: IMPROVEMENT IN THE COGNITIVE SKILLS WILL BE MEASURED BY APPROPRIATE SCALES ON BASLINE ,DURING TREATMENT ON 45TH DAY AND AFTER THE TREATMENT ON 90TH DAY	—

Countries

India

Contacts

Public ContactDr Suryanarayana M

Datta Meghe institute of medical sciences (deemed to be university)ealth

rbr.226@gmail.com9373703816

Outcome results