Comparison of the effect of magnesium and vitamin B6 on the improvement of restless leg syndrome

Compare the effect of magnesium and vitamin B6 with pramipexole in improving the symptoms of restless leg syndrome patients referred to the clinic by University of Medical Sciences.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017070134806N1

Enrollment

Registered

2017-07-27

Start date

2017-07-01

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

Restless legs syndrome. Restless legs syndrome

Interventions

Intervention 1: For the first intervention group

Pramipexolel tablets, 75 mg oral, once a day for two months & Vitamin B6 tablets 40 mg oral, once a day for two month. Intervention 2: For the second intervention group

Pramipexole 75 mg oral tablet, once a day for two months & Magnesium oxide 250 mg oral tablet, once a day for two months. Intervention 3: For control group

Pramipexole 75 mg oral tablet, once a day for two months & Placebo oral tablet, once a day for two month.

Treatment - Drugs

For the first intervention group

Pramipexolel tablets, 75 mg oral, once a day for two months & Vitamin B6 tablets 40 mg oral, once a day for two month

For the second intervention group

Pramipexole 75 mg oral tablet, once a day for two months & Magnesium oxide 250 mg oral tablet, once a day for two months

For control group

Pramipexole 75 mg oral tablet, once a day for two months & Placebo oral tablet, once a day for two month

Eligibility

Sex/Gender

All

Age

15 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Having a history of RLS for 6 months; Age 15 to 50 years; Lack of risk factors including pregnancy; Uremia; Diabetes and anemia; Lack of pregnancy; lack of renal impairment.Exclusion criteria: Unwillingness to continue the study; The occurrence of pregnancy during the study;The side effects of the drug.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Improvement of sign restless leg syndrome. Timepoint: Befor, One & Two mounth after Intervention. Method of measurement: questionnaire of IRLS.	—

Secondary

Measure	Time frame
Improve the quality of sleep. Timepoint: Befor, One & Two mounth after Intervention. Method of measurement: questionnaire of PSQ.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Jadidi

Arak University of Medical Sciences

jadidi.ali83@yahoo.comJadidi@arakmu.ac.ir+98 86 3417 3508

Outcome results

None listed

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