Comparing effect of tizanidine hydrochloride vs. placebo on muscle cramp in hemodialysis patients

Comparing effect of tizanidine hydrochloride vs. placebo on muscle cramp in hemodialysis patients in

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201510251598N3

Enrollment

Registered

2016-02-16

Start date

2010-03-20

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

muscle cramp in hemodialysis patients. Cramp and spasm,Extracorporeal dialysis

Interventions

Intervention 1: Group A at first receives tizanidine hydrochloride for one month and after 3 days washout period receives placebo for another month. Serum Na, K, calcium, phosphate, albumin, and compl

Prevention

Group A at first receives tizanidine hydrochloride for one month and after 3 days washout period receives placebo for another month. Serum Na, K, calcium, phosphate, albumin, and complete blood cell

Group B at first receives placebo for one month and after 3 days washout period receives tizanidine hydrochloride for another month. Serum Na, K, calcium, phosphate, albumin, and complete blood cell c

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Shahram Taheri

Isfahan Kidney Diseases Research Center, Isfahan University of Medical Sciences

sh_taheri@med.mui.ac.ir, shah63tah@yahoo.com+98 32 3625 5555

Outcome results

None listed

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