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Clinical efficacy evaluation of Guanaci, Heguaci combined with intramural efficacy patch in the treatment of restless leg syndrome

Clinical efficacy evaluation of Guanaci, Heguaci combined with intramural efficacy patch in the treatment of restless leg syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003586
Enrollment
Unknown
Registered
2020-08-19
Start date
2021-01-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Restless leg syndrome

Interventions

Sponsors

Yueyang Integrative Medicine Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) All primary RLS patients meet the 2014 international RLS research group diagnostic criteria; (2) No serious heart and lung diseases, no obvious liver and kidney damage, serum ferritin & GT; 50 mg/L, male hemoglobin >=120 g/L, female hemoglobin >= 110 g/L; (3) All subjects did not take drugs (such as tricyclic antidepressants, sleeping pills, and dopamine drugs, etc.) that affect the change of sleep and periodic limb movement index within 2 weeks before the examination.; (4) Sleep Apnea hypopnea index (Apnea/ Hypopnea index (AHI)) of all subjects required & LT<10/h; (5) Physical examination of the nervous system is normal.

Exclusion criteria

Exclusion criteria: (1) Serum ferritin <= 50 mg/L, male hemoglobin & LT < 120 g/L, female hemoglobin & LT < 110 g/L patients or patients with arthritis, Parkinson's disease, peripheral neuropathy and nerve root disease; (2) Persons with serious heart and lung diseases and obvious liver and kidney damage; (3) Take drugs (such as tricyclic antidepressants, sleeping pills, and dopamine drugs) that affect the change of sleep and periodic limb movement index within 2 weeks before polysomnography examination.

Design outcomes

Primary

MeasureTime frame
Chalder Fatigue Scale;Polysomnogram;Depression scale;PSQI scale;The brain PET-CT;The brain fMRI;Anxiety Scale;Self-rating scale for the severity of restless leg syndrome;RLS Quality of Life Scale;

Countries

China

Contacts

Public ContactWenjia Yang

Yueyang Integrative Medicine Hospital affiliated to Shanghai University of Traditional Chinese Medicine

yangwenjia1030@163.com+86 15800690158

Outcome results

None listed

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