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

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Collaborators: Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine; Nanjing Hospital of Chinese Medicine affiliated to Nanjing University of Chinese Medicine; Shanghai Municipal Hospital of Traditional Chinese Medicine; Shanghai University of Traditional Chinese Medicine; The Affiliated Hospital of Qingdao University; The Affiliated Hospital of Xuzhou Medical University; Wenzhou Central Hospital
• Treatments: Amantadine

Criteria

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.