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

Last updated: November 20, 2019
Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dyskinesias

Treatment

N/A

Clinical Study ID

NCT04173845
XHEC-C-2019-033-2
  • Ages 30-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 clinicalintervention.

  10. PD related brain surgery

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

  12. Patients unable to cooperate with the survey

Study Design

Total Participants: 150
Study Start date:
September 01, 2019
Estimated Completion Date:
December 31, 2021

Study Description

The aim of this clinical trail is to evaluate the effect of Tianqi Pingzhan Granule in the prevention of levodopa induced dyskinesia in adults. All patients included in the study should meet the inclusion criteria. Half of participants will receive Tianqi Pingzhan Granule, while the other half will receive a placebo of Tianqi Pingzhan Granule. All participants will be assigned to either the active group or the control group randomly. During the clinical trail both doctors and patients are double-blind except serious adverse events occurred.

Connect with a study center

  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai 200092
    China

    Active - Recruiting

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