Clinical Study on Treatment of L-DOPA-Induced Dyskinesia With Tianqi Pingchan Granule Combined With Amantadine

Shanghai Jiao Tong University

Status: Unknown

Conditions: L-DOPA-Induced Dyskinesia

Treatments: Drug: Placebo Combined With Amantadine; Drug: Tianqi Pingchan Granule Combined With Amantadine

Study type: Interventional

Funder types: Other

Identifiers

NCT04173832

XHEC-C-2019-032-2

Details and patient eligibility

About

A randomized, double-blind, placebo-controlled, multi-center clinical trial was conducted to observe the improvement in the level of dyskinesia in patients with Parkinson's disease during the 12-week period of oral treatment with Tianqi Pingchan Granule Combined With Amantadine. To observe the differences of the safety and effectiveness between Tianqi Pingchan Granule combined with amantadine and placebo combined with amantadine.

Enrollment: 100 estimated patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. PD patients between the ages of 30-85;
2. Patients with Parkinson's disease dyskinesia, and UPDRS 4.2 score ≥ 2 points;
3. The patient diary shows that there are at least two opening periods between 9 am and 4 pm every day, and the dyskinesia appears in the opening period, each time lasting more than half an hour;
4. The treatment plan for anti-Parkinson's disease is stable and not adjusted within 30 days before enrollment;
5. Levodopa is administered at least three times a day.

Exclusion criteria

1. PD patients with biphasic, dystonia, closure, myoclonus, but no dyskinesia;
2. pregnant and lactating women;
3. Taking other Chinese medicines against Parkinson's disease 2 weeks before enrollment;
4. Impaired cognitive function (according to pre-entry MMSE score): secondary education level: MMSE <24 points; primary education level <20 points; illiterate <17 points;
5. Psychiatric symptoms associated with anti-Parkinson's disease drugs
6. accompanied by a history of mental illness;
7. impaired liver and kidney function;
8. accompanied by severe other systemic diseases;
9. Amantadine treatment has been received within the first 30 days of enrollment;
10. History of medication with apomorphine or dopamine receptor antagonists;
11. Previously taking amantadine, unable to tolerate;
12. Allergic to the amantadine, memantine, and traditional Chinese medicine preparations or serious adverse reactions;
13. Before the enrollment, the EKG showed obvious abnormalities and required clinical intervention.
14. has received PD-related brain surgery;
15. Patients who are participating in other clinical studies or have participated in other clinical studies within the previous 30 days;
16. Patients who are unable to follow up with follow-up.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

Tianqi Pingchan Granule Combined With Amantadine

Experimental group

Treatment:

Drug: Tianqi Pingchan Granule Combined With Amantadine

placebo Combined With Amantadine

Placebo Comparator group

Treatment:

Drug: Placebo Combined With Amantadine