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To compare the efficacy of pregabalin and amitriptyline in central post stroke pain

COMPARISON BETWEEN THE EFFICACY OF PREGABALIN VS AMITRYPTILINE MONOTHERAPY IN CENTRAL POST STROKE PAIN. AN OPEN LABEL RANDOMISED CONTROL TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/08/027366
Enrollment
72
Registered
2020-08-26
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: G890- Central pain syndrome

Interventions

Intervention1: Pregabalin: PREGABALIN started at 150 mg/day in two divided doses and titrated in 1 week max upto 300 mg/day in two divided doses Control Intervention1: Amitryptiline: AMITRYPTILINE st

Sponsors

AIIMS Bhubaneswar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient of age > 18 years to be taken into the study. 2. Ischaemic, haemorhagic or cardioembolic all types of strokes are to be included. 3. Patients with intact sensorium to be included only. 4. Patients having score more than 5 on visual analogue scale to be included in the study. 5. Patients who are already on any other drugs for CPSP can be included in the study after providing a washout period of two weeks. 6. Only first episode stroke patients to be taken in the study. 7. Presenting in neurology OPD/IPD/Emergency of AIIMS Bhubaneswar. 8. Period of recruitment of patients presenting between July 2020 to May 2022.

Exclusion criteria

Exclusion criteria: 1. Patients with history of recurrent stroke to be excluded. 2. Venous strokes to be excluded 3. Patients with altered sensorium at the baseline to be excluded. 4. Other forms of post stroke pain like undefined complex regional pain syndrome, subluxation of shoulder to be excluded. 5. Patients with any comorbidities that limits the use of the drugs involved in the study to be excluded at baseline.

Design outcomes

Primary

MeasureTime frame
more than 50% reduction in visual analogue scale from the baseline to endpointTimepoint: 3 months

Secondary

MeasureTime frame
Change in the Barthel index score from baseline to endpoint. Modified Rankin scale (mRS) scale comparison from baseline to endpoint. Hospital anxiety and depression scale comparison from baseline to endpoint. Electrophysiological assessment at the baseline and endpoint. Timepoint: 3 months

Countries

India

Contacts

Public ContactDr Camelia Porey

AIIMS Bhubaneswar

bhoisanjeev@gmail.com9919787978

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026