Health Condition 1: I693- Sequelae of cerebral infarction
Conditions
Interventions
Intervention1: Teneligliptin: Intervention Arm—Teneligliptin 20 mg, One tablet to be taken orally, once daily, for 3 months.
Control Intervention1: The standard stroke therapy follows the guidelines s
Sponsors
SRM Medical College Hospital And Research Centre
Eligibility
Inclusion criteria
Inclusion criteria: Eligible participants must have a diagnosis of ischemic stroke confirmed through clinical examination and neuroimaging (CT/MRI), with the stroke onset occurring 7 to 30 days prior to enrollment. Candidates are required to exhibit notable motor deficits, as indicated by a Fugl-Meyer Assessment (FMA) motor score of 80 or less out of 100. Additionally, participants must present with cognitive decline, defined by a Montreal Cognitive Assessment (MoCA) score of 25 or less.
Exclusion criteria
Exclusion criteria: Individuals will be excluded from participation if they have a diagnosis of haemorrhagic stroke confirmed by CT or MRI, or a known hypersensitivity or allergy to dipeptidyl peptidase-4 (DPP-4) inhibitors, including Teneligliptin. Further exclusion criteria include severe hepatic impairment, defined as ALT/AST levels greater than three times the upper limit of normal or a Child–Pugh class C classification. Pregnant or lactating women, as confirmed by a urine pregnancy test, are also ineligible. Lastly, patients with severe motor impairment, indicated by a Fugl-Meyer Assessment (FMA) motor score of 20 or less, will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of Teneligliptin on motor function recovery in post-ischemic stroke patients, measured by changes in Fugl-Meyer Assessment (FMA) scores over 12 weeksTimepoint: Baseline (week 0), Weeks 2,4,6,8 and 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess improvement in independence in activities of daily living using the Barthel Index.Timepoint: Baseline (week 0), Weeks 2,4,6,8 and 12;Evaluate cognitive function using the Montreal Cognitive Assessment (MoCA).Timepoint: Baseline (week 0), Weeks 2,4,6,8 and 12;To measure the overall protein profile in serum samples using MALDI-TOF mass spectrometry, comparing pre and post-treatment states to identify potential biomarker changes associated with recovery.Timepoint: Baseline (week 0), Weeks 2,4,6,8 and 12;Assess neuroimaging parameters of brain structure and connectivity (subset via MRI/DTI)Timepoint: Baseline (Week 0) and week 12 | — |
Countries
India
Contacts
Public ContactAkash Mohan
SRMMCHRC, SRMIST
Outcome results
None listed