Clinical efficacy evaluation of Guanaci, Heguaci combined with intramural efficacy patch in the treatment of restless leg syndrome
- Conditions
- Restless leg syndrome
- Registration Number
- ITMCTR2000003586
- Lead Sponsor
- Yueyang Integrative Medicine Hospital affiliated to Shanghai University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(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.
(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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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;
- Secondary Outcome Measures
Name Time Method