A randomized, double-blind, placebo-controlled, placebo-controlled trial for Jiawei Zhichan Decoction for the treatment of sleep disorders in Parkinson's disease

Not Applicable

Conditions: Parkinson's Disease

Registration Number: ITMCTR2000003654

Lead Sponsor: Shanghai Municipal Hospital of Traditional Chinese Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. In line with the diagnostic criteria of Western medicine for Parkinson's disease;
2. Aged between 40 to 85 years old;
3. In accordance with the diagnostic criteria of western medicine for sleep disorders, or PDSS in any one score < 5 is classified as sleep disorders;
4. In line with the diagnostic criteria of TCM fibrillation syndrome of liver-kidney Yin deficiency;
5. Improved Hoehn-Yahr grading <=3;
6. Those who sign the informed consent.

Exclusion Criteria

1. Patients with severe heart failure, renal failure, abnormal liver function, etc. that affect the curative effect evaluation of this disease;
2. Mental illness, epilepsy, pregnant women and lactating women;
3. People with aphasia, deaf-mute or severe cognitive impairment;
4. Patients with Parkinson's syndrome and Parkinson's superposition syndrome;
5. Participants in other clinical trials within 2 months.

Study & Design

Study Type: Interventional study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
nified Parkinson's Disease Rating Scale,UPDRS;Parkinson's disease sleep scale, PDSS;International Restless Legs Scale, IRLS;Hamilton Anxiety Scale, HAMA;Rapid-eye-movement Sleep Behavior Disorder Questionnaire Hongkong, RBDQ-HK;Epworth Sleeping Scale, ESS;Hamilton Depression Scale, HAMD;International Restless Legs Scale, IRLS;Hoehn-Yahr, H-Y;

Secondary Outcome Measures