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Effect of citicoline versus placebo on clinical signs in patients with acute ischemic and hemorrhagic stroke

Effect of citicoline versus placebo on clinical signs in patients with acute ischemic and hemorrhagic stroke: a triple blind control trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201601289014N90
Enrollment
160
Registered
2016-02-24
Start date
2016-02-20
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

stroke. Stroke, not specified as haemorrhage or infarction

Interventions

Intervention 1: Intervention group: Infusion of citicoline 1 gr in normal saline (overall 20 ml) once daily for 10 days. Intervention 2: Control group: Infusion of 20 ml normal saline once daily for 1
Treatment - Drugs
Placebo
Intervention group: Infusion of citicoline 1 gr in normal saline (overall 20 ml) once daily for 10 days
Control group: Infusion of 20 ml normal saline once daily for 10 days

Sponsors

Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: (a) age of 18 to 85 years; (b) acute stroke; (c) NIHSS score between 6 to 22. Exclusion criteria: (a) previous history of stroke; (b) renal or liver failure; (c) cancer; (d) active infectious disease during last month; (e) trauma or surgery during last month; (f) history of collagen vascular disease; (g) immunosuppressive medications or corticosteroid; (h) signs of brain hernia; (i) convulsion at the time of stroke; (j) neurologic disease or dementia; (k) pregnancy or breastfeeding; (l) receiving vasodilator medications.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Measuring stroke score (NIHSS ). Timepoint: at baseline and 10 and 90 days after intervention. Method of measurement: based on NIHSS.;Measuring stroke score (Barthel Index). Timepoint: at baseline and 10 and 90 days after intervention. Method of measurement: based on Barthel Index.;Measuring stroke score (Modified Rankin Scale). Timepoint: at baseline and 10 and 90 days after intervention. Method of measurement: based on Modified Rankin Scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Shahir Mazaheri

Sina Hospital

sh.mazaheri@umsha.ac.ir+98 81 3827 4184

Outcome results

None listed

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