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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Levodopa-Induced Dyskinesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tianqi Pingchan Granule group

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.

Group Type EXPERIMENTAL

Tianqi Pingchan Granule

Intervention Type DRUG

Tianqi Pingchan Granule are given twice a day

Tianqi Pingchan Granule Placebo group

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

Group Type PLACEBO_COMPARATOR

Tianqi Pingchan Granule Placebo

Intervention Type DRUG

Tianqi Pingchan Granule Placebo

Interventions

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Tianqi Pingchan Granule

Tianqi Pingchan Granule are given twice a day

Intervention Type DRUG

Tianqi Pingchan Granule Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No