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Clinical trial on efficacy and safety of add-on treatment of Butylphthalide in patients with Parkinson's disease in early and moderate stage

Clinical trial on efficacy and safety of add-on treatment of Butylphthalide in patients with Parkinson's disease in early and moderate stage

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-16009395
Enrollment
Unknown
Registered
2016-10-14
Start date
2016-11-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Parkinson’s disease

Interventions

Butylphthalide group and Control group:Butylphthalide 200mg/time(2 capsules) , three time/day, for 24 weeks

Sponsors

The Second Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Meet the clinical diagnostic criteria for primary Parkinsons disease and require at least 2 of the cardinal motor manifestations (bradykinesia, tremor or rigidity). Clearly not attributable to other secondary parkinsonism; 2. Modified H-Y stage < 3; 3. Aged 35 years old and elder; 4. Stability of symptoms and signs over 1month or more; 5. MDS-UPDRS Part III score = 10 at baseline; 6. Dose of levodopa daily=300mg; 7. An informed consent has been signed by the patient himself/herself before the study.

Exclusion criteria

Exclusion criteria: 1. Hepatic function abnormality (ALT/AST >1.5 times ULL), renal function abnormality (Cre>2.0mg/dl or 177 umol/L), cardiac dysfunction or with other severe systemic disease; 2. With occurrence of any malignancy or under oncotherapy; 3. Being allergic to celery or Butylphthalide; 4. Patient who is within the gestation period or have any possibility or intention to get pregnant; 5. Have been involved in other intervention study in the last 3 months or is now under other intervention study; 6. Patients, considered by the investigators, who is not suitable for this study.

Design outcomes

Primary

MeasureTime frame
UPDRS (UPDRS part I + II + III);portable device evaluation;

Countries

China

Contacts

Public ContactLiu Chunfeng

The Second Affiliated Hospital of Soochow University

Liucf20@hotmail.com+86 13606210609

Outcome results

None listed

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