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Clinical study of Guizhilongmu Prescription combined with Shudipingchan Prescription in the treatment of Parkinson's disease with circadian rhythm disturbance

Clinical study of Guizhilongmu Prescription combined with Shudipingchan Prescription in the treatment of Parkinson's disease with circadian rhythm disturbance

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072497
Enrollment
Unknown
Registered
2023-06-15
Start date
2023-06-15
Completion date
Unknown
Last updated
2023-06-18

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

Conditions

Parkinson's disease

Interventions

Treatment Group:Guizhilongmu Prescription combined with Shudipingchan Prescription
Control Group:The Mimic Agent of Guizhilongmu Prescription combined with Shudipingchan Prescription

Sponsors

Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: ? Age 30-80 years old, both sexes; ? Meet The Movement Disorder Society (MDS) 2015 revised diagnostic criteria for primary Parkinson's disease; ? Hoehn-Yahr stage =3; ? The Chinese University of Hong Kong rapid eye movement Sleep Behavior Disorder Scale (RBDQ-HK) =17 points ? At least one of the following symptoms: fear of cold and heat; Constipation or diarrhoea; ? For those already on anti-Parkinsonian therapy (levodopa agents, dopamine agonists, monoamine oxidase inhibitors, catechol-O-methyltransferase inhibitors, anticholinergic drugs, etc.), the dose of anti-parkinsonian drugs was required to be relatively stable for at least 3 months before this clinical trial; And no clear plan to change the current treatment regimen in the next 3 months; ? Voluntary participation and signed informed consent.

Exclusion criteria

Exclusion criteria: ? Patients with Parkinson's disease syndrome or Parkinson's disease plus syndrome; ? Active depression or psychosis and/or antidepressant or antipsychotic medication; ? Sequelae of severe stroke and diseases of heart, lung, liver, kidney and other systems; ? History of drug abuse or alcohol abuse; ? Patients who are participating in other clinical studies or have participated in other clinical studies within the previous 30 days.

Design outcomes

Primary

MeasureTime frame
RBD Questionnaire-HongKong(RBDQ-HK);

Secondary

MeasureTime frame
Unified Parkinson’s Disease Rating Scale, UPDRS;SCOPA-AUT;Hamilton Anxiety Scale, HAMA;Hamilton Depression Scale, HAMD;Parkinson's disease questionnaire-39, PDQ-39;Parkinson's Disease Sleep Scale, PDSS;Polysomnogram, PSG;

Countries

China

Contacts

Public ContactYou Wu

Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine

kathyyouyou@126.com+86 137 6168 5437

Outcome results

None listed

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