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Comparative efficacy of Cyproheptadine and Baclofen on spasticity in patients with head trauma

Comparative efficacy of Cyproheptadine and Baclofen on spasticity in patients with head trauma

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014041112777N1
Enrollment
40
Registered
2014-05-13
Start date
2014-08-22
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

Head Trauma. Multiple superficial injuries of head

Interventions

Intervention 1: Drugs: 1- Cyproheptadine: Dose: 2 mg/kg Number of using:Forty five times Factory name: Jalinus Country's Name: Iran Location prescribed: Oral Administration time: Every eight hours
Treatment - Drugs
Baclofen: Dose: 25 mg/kg Number of using: Forty five times Factory name: Mylan Country's Name: England Location prescribed: Oral Administration time: Every eight hours
Drugs: 1- Cyproheptadine: Dose: 2 mg/kg Number of using:Forty five times Factory name: Jalinus Country's Name: Iran Location prescribed: Oral Administration time: Every eight hours 2- Bacl

Sponsors

Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients with diffuse axonal injury without chronic hepatic or renal disease; 15 to 60 years old. Exclusion criteria: Changing in treatment plan like surgery; drug reactions; drug side effects.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Spasticity. Timepoint: 1, 3, 6, 9, 12, 15 days. Method of measurement: Modified Ashworth Scale.

Secondary

MeasureTime frame
Alanine Transaminase (ALT). Timepoint: Weekly. Method of measurement: U/ml.;Blood Urea Nitrogen(BUN). Timepoint: Daily. Method of measurement: Mg/dl.;Aspartate Amino Transferase(AST). Timepoint: Weekly. Method of measurement: U/ml.;Alkaline Phosphatase(ALP). Timepoint: Weekly. Method of measurement: U/ml.;Creatinine. Timepoint: Daily. Method of measurement: Mg/dl.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSoheil Fallahpour

Ahvaz Jundishapur University of Medical Sciences

Fallahpour.s@ ajums.ac.ir, Fatahi.m@ajums.ac.ir+98 61 1374 3032

Outcome results

None listed

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