NCT04173845

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 22, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

November 22, 2019

Status Verified

October 1, 2019

Enrollment Period

1.3 years

First QC Date

November 5, 2019

Last Update Submit

November 20, 2019

Conditions

Levodopa-Induced Dyskinesia

Outcome Measures

Primary Outcomes (1)

  • new dyskinesia attack

    The occurrence of Levodopa-Induced dyskinesia

    48 weeks

Secondary Outcomes (11)

  • Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

    48 weeks

  • Patient diaries

    48 weeks

  • MMSE（Mini-Mental State Examination）

    48 weeks

  • HAMA (Hamilton Anxiety Scale)

    48 weeks

  • HAMD-24(Hamilton Depression Scale-24)

    48 weeks

  • +6 more secondary outcomes

Study Arms (2)

Tianqi Pingchan Granule group

EXPERIMENTAL

Tianqi Pingchan Granule were manufactured according to Good Manufacturing Practice (GMP) by Sichuan Neo-Green Pharmaceutical Technology Development Co., Ltd. , granule, twice a day, for six months.

Drug: Tianqi Pingchan Granule

Tianqi Pingchan Granule Placebo group

PLACEBO COMPARATOR

placebo, granule, twice a day, for six months.

Drug: Tianqi Pingchan Granule Placebo

Interventions

Tianqi Pingchan GranuleDRUG

Tianqi Pingchan Granule are given twice a day

Tianqi Pingchan Granule group
Tianqi Pingchan Granule PlaceboDRUG

Tianqi Pingchan Granule Placebo

Tianqi Pingchan Granule Placebo group

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with PD aged 30-85，have at least the following two conditions:
  • Dosage of Levodopa ≥ 400mg/d;
  • Grade of H\&Y≥3;
  • risk score of dyskinesia\>4;

You may not qualify if:

  • PD patients with dyskinesia;
  • Taking other Chinese medicines against Parkinson's disease;
  • pregnant and lactating women;
  • Impaired cognitive function (according to pre-entry MMSE score):
  • secondary education level: MMSE \<24 points; primary education level \<20 points; illiterate \<17 points;
  • accompanied by a history of mental illness;
  • impaired liver and kidney function;
  • accompanied by severe other systemic diseases;
  • Previous traditional Chinese medicine preparations or serious adverse reactions
  • Before the enrollment, the EKG showed obvious abnormalities and required clinical intervention.
  • PD related brain surgery
  • Patients who are participating in other clinical studies or has participated other clinical studies within 30 days before
  • Patients unable to cooperate with the survey

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

Study Officials

  • Zhenguo Liu, MD

    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Na Wu, MD

CONTACT

13524185616nanakingkitty@163.com

Zhenguo Liu, MD

CONTACT

8602125077501zhenguoliu2004@aliyun.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2019

First Posted

November 22, 2019

Study Start

September 1, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2021

Last Updated

November 22, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)