Role of Ocimum Sanctum in Drug Resistance Epilepsy

A double-blind, randomized, placebo-controlled trial assessing Ocimum sanctum extract as adjuvant therapy in persons with drug-resistant epilepsy - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/11/076894

Enrollment

114

Registered

2024-11-18

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

Health Condition 1: G- Mental Health

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: a.Clinically diagnosed persons with drug-resistant epilepsy (definition as per ILAE) b. Patient with epilepsy on stable AEMs treatment regimen for at least 4 weeks c. Subject having seizure frequency = 2 per month d. Subject of age 18 to 60 years of either gender. e. No herbal drug/ ayurvedic supplementation in the past 3 months f. Ability to maintain a seizure diary.

Exclusion criteria

Exclusion criteria: a) Pregnant or seeking pregnancy, lactating women b) Associated neurological and clinically diagnosed psychiatric diseases other than epilepsy c)Progressive brain diseases Subject undergoing ASM tapering d)Patient on drugs known to alter seizure threshold (e.g. INH, theophylline, metronidazole, etc.) e) Patient on antitubercular drugs or any other drugs known to cause interaction with AEMs (e.g. isoniazid, fluoxetine, fluvoxamine, clarithromycin, erythromycin, fluconazole, etc.) f) Subject refused to give informed consent g) Subjects which require epileptic surgery and those who had Status epilepticus in the past 3 months h) H/o Poor compliance to AEMs

Design outcomes

Primary

Measure	Time frame
To evaluate change in seizure frequency (%) in OSE add-on group (Ocimum group) compared to the placebo add-on group (Placebo group) after 3 months of intervention in DRE subjects who are on ongoing ASMs treatment.Timepoint: 6 months	—

Secondary

Measure	Time frame
To evaluate responder rate, % of seizure frequency reduction based on seizure/epilepsy type, and after 3 months of stoppage of interventionTimepoint: 6 months;To assess biomarkers related to epileptogenesisTimepoint: 6 months;To assess the quality of lifeTimepoint: 6 months;To assess the medication adherenceTimepoint: 6 months	—

Countries

India

Contacts

Public ContactDr Sudhir Chandra Sarangi

All India Institute of Medical Sciences New Delhi

scsarangi@gmail.com8518881757

Outcome results