Comparing effect of tizanidine hydrochloride vs. placebo on muscle cramp in hemodialysis patients
Phase 3
- Conditions
- muscle cramp in hemodialysis patients.Cramp and spasm,Extracorporeal dialysisR25.2,Z49.
- Registration Number
- IRCT201510251598N3
- Lead Sponsor
- Isfahan Kidney Diseases Research Center, Isfahan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
At least 18 year old; give informed consent to participate in the 2 month clinical trial; at least has once weekly muscle cramp episode during previous month; stable hemodialysis patients and no hypotension during muscle cramp episode (Systolic BP=90 mmHg); chronic hemodialysis patients for at least 3 months; serum calcium level= 8.3 mg/dL;
serum sodium level= 135 mEq/L
Exclusion criteria:
side effect appearing to tizanidine; any time patient wishes to exit from the study.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Muscle cramp frequency. Timepoint: During hemodialysis session. Method of measurement: Observation by responsible hemodialysis nurse.;Muscle cramp intensity. Timepoint: During hemodialysis session. Method of measurement: Visual analog scale.;Muscle cramp duration (second). Timepoint: During hemodialysis session. Method of measurement: Measuring by responsible nurse.
- Secondary Outcome Measures
Name Time Method Systolic and diastolic blood pressure. Timepoint: At the time of tizanidine hydrochloride or placebo prescription and then at the start of hemodialysis session and hourly during hemodialysis and at the start of each muscle cramp episode. Method of measurement: Sphigmomanometer by responsible nurse.;Pulse rate (beats per minute). Timepoint: At the time of tizanidine hydrochloride or placebo prescription and then at the start of hemodialysis session and hourly during hemodialysis and at the start of each muscle cramp episode. Method of measurement: watch, by responsible nurse.