Double Randomized and Placebo Controlled Trail of Tianqi Pingchan Granule to Prevent Levodopa-Induced Dyskinesia

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

Summary

A randomized, double-blind, placebo-controlled multicenter clinical trial was used to observe the effectiveness, safety and side effects of Tianqi Pingzhan Granule in the prevention of levodopa induced dyskinesia, so as to determine the clinical efficacy of Tianqi Pingzhan Granule in the prevention of levodopa induced dyskinesia.

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

Details

• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Collaborators: Huai'an First People's Hospital; Nanjing Hospital of Chinese Medicine affiliated to Nanjing University of Chinese Medicine; Suqian Branch, Jiangsu Province Hospital; Xin Hua Hospital of Zhejiang Province
• Treatments: Levodopa

Criteria

Inclusion Criteria:

Patients with PD aged 30-85，have at least the following two conditions:

1. Dosage of Levodopa ≥ 400mg/d;

2. Grade of H&Y≥3;

3. risk score of dyskinesia>4;

Exclusion Criteria:

1. PD patients with dyskinesia;

2. Taking other Chinese medicines against Parkinson's disease;

3. pregnant and lactating women;

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. accompanied by a history of mental illness;

6. impaired liver and kidney function;

7. accompanied by severe other systemic diseases;

8. Previous traditional Chinese medicine preparations or serious adverse reactions

9. Before the enrollment, the EKG showed obvious abnormalities and required clinical intervention.

10. PD related brain surgery

11. Patients who are participating in other clinical studies or has participated other clinical studies within 30 days before

12. Patients unable to cooperate with the survey