Study for Syndrome Differentiation of Traditional Chinese Medicine in the Treatment of Parkinson's Disease With Deep Brain Stimulation: a Randomized Controlled Tiral

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2000003209

Enrollment

Unknown

Registered

2020-04-13

Start date

2020-05-01

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

Control Group:placebo

Experimental group:Traditional Chinese Medicine syndrome differentiation treatment

Eligibility

Sex/Gender

All

Age

45 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 45-75 years old with primary Parkinson's disease after DBS; 2. Patients whose course of Parkinson's disease is 5 years or more; 3. Hoehn Yahr (H-Y) was divided into two or more stages under the condition of "off" (not taking medicine); 4. UPDRS score >= 30 in "off" state; 5. The patients who respond well to dopamine drugs and improved the UPDRS score of acute levodopa test more than 30% (medoba 250mg); 6. Patients whose daily drug clearance period is at least 6 hours, or who have serious movement complications such as abnormal movement, and who can not be effectively improved by repeated adjustment of drugs; 7. Patients with MMSE score >= 24.

Exclusion criteria

Exclusion criteria: 1. Patients who have received surgery for Parkinson's disease other than deep brain stimulation, such as stereotactic lesion, cell transplantation, gamma knife, etc.; 2. "Off" state has severe middle line symptoms such as language disorder, dysphagia and balance disorder; 3. There are contraindications of Neurosurgery, such as cerebral infarction, hydrocephalus, brain atrophy, ventricular enlargement, sequelae of cerebrovascular disease, heart disease, severe thrombocytopenia and other cardiovascular and cerebrovascular diseases; 4. Patients with other concomitant diseases who have or need to be implanted with pacemakers, defibrillators, cochlear implants and other nerve stimulators; 5. Patients with tumor, serious abnormality of liver function and kidney function (index more than three times of normal value) and other concomitant diseases that seriously affect health.

Design outcomes

Primary

Measure	Time frame
TCM syndrome curative effect index;PDQ-39;MDS-UPDRS-III;	—

Countries

China

Contacts

Public ContactYu Ma

School of Medicine Tsinghua University; Tsinghua University Yuquan Hospital

mayu@tsinghua.edu.cn+86 13501085569

Outcome results

None listed

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