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

Not Applicable

Not yet recruiting

• 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

Study Timeline

• Last Update Posted: 2023-02-20

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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

(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