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

Ocimum sanctum extract as an adjuvant therapy in persons with drug resistant epilepsy: A double blind, randomized, placebo controlled study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/03/050631

Enrollment

Registered

2023-03-13

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: G408- Other epilepsy and recurrent seizures

Interventions

None listed

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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 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. 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 QOLIE-10 score LEAP score MOCA score Adverse event reorting Timepoint: HMGB1 and NT3 level at baseline and 3rd month All other secondary endpoint at baseline,1st,2nd,3rd month	—

Measure

Time frame

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 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. 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 QOLIE-10 score LEAP score MOCA score Adverse event reorting Timepoint: HMGB1 and NT3 level at baseline and 3rd month All other secondary endpoint at baseline,1st,2nd,3rd month

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Countries

India

Contacts

Public ContactVarnit Kaushik

All India institute of medical sciences

surenderaiims@gmail.com9810882350

Outcome results