Efficacy and safety of ocimum sanctum extract (holybasil/Tulsi) as an add on therapy in drug resistant epilepsy patients

Phase 3

Conditions: Health Condition 1: G408- Other epilepsy and recurrent seizures

Registration Number: CTRI/2023/03/050631

Lead Sponsor: All India institute of medical science

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1)Clinically diagnosed persons with drug resistant epilepsy (as per ILAE definition)

2)Subjects with epilepsy on stable ASDs treatment regimen for at least 4 weeks

3)Subject having seizure frequency at least 2 per month

4)Subject of age 18 to 60 years of either gender.

5)Ability to maintain seizure diary.

Exclusion Criteria

•Pregnant or seeking pregnancy, lactating women

•Associated neurological and clinically diagnosed psychiatric diseases other than epilepsy

•Progressive brain diseases

•Subject undergoing ASD tapering

•Subjects on any herbal drug/ ayurvedic supplementation in the past 3 months

•Subjects on drugs known to alter seizure threshold (e.g. INH, theophylline, metronidazole etc.)

•Subjects on antitubercular drugs or any other drugs known to cause interaction with ASDs (e.g. isoniazid, fluoxetine, fluvoxamine, clarithromycin, erythromycin, fluconazole etc.)

•Subject refused to give informed consent

•Subjects which require epileptic surgery in immediate next 3 months and those who had status epilepticus in the past 3 months

•H/o poor compliance to ASDs

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint: Seizure frequency data will be collected along with other seizure details like: <br/ ><br>a)Age of onset of seizure <br/ ><br>b)Type of seizure <br/ ><br>c)Seizure frequency <br/ ><br>d)Duration of seizure episode <br/ ><br>e)Secondarily/generalised seizure <br/ ><br>f)Seizure diary <br/ ><br>Timepoint: Primary outcome endpoints will be assessed at baseline, 1 month, 3rd month <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
a)For biomarkers HMGB1 and NT3: 3 ml blood will be collected in an anti-coagulant free BD vacutainer serum tubes & centrifuged to collect aliquot supernatant (serum) and will be analyzed by ELISA kit assay <br/ ><br>b)For safety endpoint assessment: hematological investigation (CBC), biochemical investigations (LFT, RFT, lipid profile, RBS), LEAP score will be recorded at baseline,1st month, and 3rd month. <br/ ><br>c)For quality of life outcome assessment by QOLIE-10 score and for neurocognitive development Montreal cognitive assessment scale scoring will be recorded at baseline, 3rd month <br/ ><br>QOLIE-10 score <br/ ><br>LEAP score <br/ ><br>MOCA score <br/ ><br>Adverse event reorting <br/ ><br> <br/ ><br>Timepoint: HMGB1 and NT3 level at baseline and 3rd month <br/ ><br>All other secondary endpoint at baseline,1st,2nd,3rd month