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Cannabidiol in Restless Leg Syndrome

Comparison of the effectiveness of Cannabidiol drop with Pramipexole in Restless Leg Syndrome severity index - randomized parallel clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210901052359N1
Enrollment
40
Registered
2021-10-03
Start date
2021-09-23
Completion date
Unknown
Last updated
2021-11-01

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

Conditions

Restless Leg syndrome. Restless legs syndrome

Interventions

Intervention 1: Intervention group: KMT(Khosro Medisa Teb) Group Cannabidiol C2 drops containing 5 mg per ml of the liposomal form of cannabidiol will be used. At the beginning of the intervention, on

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Fulfill RLS criteria based on International Restless Legs Syndrome Study Group (IRLSSG) consensus criteria 2014 Normal CBC, serum AST, ALT, Alp, BUN, Cr Serum ferritin level above 50 ng/ml Informed consent

Exclusion criteria

Exclusion criteria: Taking drugs that have a hepatic metabolism such as warfarin, anticonvulsants, antibiotics Taking dopamine antagonist drugs and other RLS treatment drugs during the past month History of drug abuses and impulse control disorders History of other sleep disorders History of other diseases related to the peripheral and central nervous systems History of cardiovascular, liver, kidney diseases and arrhythmia Pregnancy, lactation and patients using unsafe contraceptive methods Soy allergy

Design outcomes

Primary

MeasureTime frame
Restless Legs Syndrome Rating Scale. Timepoint: before intervention, 4 and 8 weeks after intervention. Method of measurement: Restless Legs Syndrome Rating Scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactTara Khoeini

Iran University of Medical Sciences

tara.khoeini@gmail.com+98 21 2207 3647

Outcome results

None listed

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