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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003654
Enrollment
Unknown
Registered
2020-08-23
Start date
2021-05-01
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

Parkinson's Disease

Interventions

Sponsors

Shanghai Municipal Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 85 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Unified 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

MeasureTime frame
5-HT;MLT;Polysomnography, PSG;

Countries

China

Contacts

Public ContactWeiwei Wang

Shanghai Municipal Hospital of Traditional Chinese Medicine

weiwei4hsjs@aliyun.com+86 13585808430

Outcome results

None listed

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