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

Last updated: November 29, 2020
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

NCT04173832
XHEC-C-2019-032-2
  • Ages 30-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 4pm every day, and the dyskinesia appears in the opening period, each time lasting morethan half an hour;
  4. The treatment plan for anti-Parkinson's disease is stable and not adjusted within 30days before enrollment;
  5. Levodopa is administered at least three times a day.

Exclusion

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 educationlevel: 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 preparationsor serious adverse reactions;
  13. Before the enrollment, the EKG showed obvious abnormalities and required clinicalintervention.
  14. has received PD-related brain surgery;
  15. Patients who are participating in other clinical studies or have participated in otherclinical studies within the previous 30 days;
  16. Patients who are unable to follow up with follow-up.

Study Design

Total Participants: 100
Study Start date:
January 01, 2020
Estimated Completion Date:
December 31, 2021

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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