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Phase III Study of 5LGr to Treat Tic Disorder

NCT ID: NCT01501695

Last Updated: 2012-12-12

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

603 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-10-31

Brief Summary

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The purpose of this study is to evaluate the effective and safety of 5LGr in pediatric patients with tic disorders.

Detailed Description

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5LGr is a kind of traditional Chinese medicine(TCM) which under the direction of TCM theory.The aim of this study is prove the effective and safety of 5LGr in children and adolescence of Tic syndrome sub-population with specific TCM syndrome differentiation, when compared with tiapride and placebo.

Conditions

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Tic Disorder Tourette Syndrome Chronic Tic Disorder

Keywords

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tic disorder pediatric

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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5LGr, granule and placebo tablet

Drug:5LGr; Dosage form:Granule;Strength:5 gram/sack;Mimic Tablet:0 mg/tablet. Dosage: 5LGr Granule: 1 sack, t.i.d. for patients less than 12 yrs,whereas 1.5 sacks, t.i.d. for patients 13-18 yrs.

Mimic tablet:For patients 5-12 yrs: 0.5 tablet, b.i.d for first 2 weeks, then 1 tablet, bid for next 6 weeks; for patients 13-18 yrs: tablet b.i.d for first 2 weeks, then 2 tablets b.i.d for next 6 weeks.

Duration: 8 weeks.

Group Type EXPERIMENTAL

5LGr

Intervention Type DRUG

Dosage form:Granule Strength:5 gram/sack Dosage:1 sack for patients less than 12 yrs 1.5 sacks for patients 13-18 yrs. Frequency: three times per day. Duration: 8 weeks.

tiapride tabletand mimic 5LGr granule

Tiapride are 100 mg scored tablets. Mimic 5LGr granule are preparation that contain no active ingredient, and act as placebo.

Dosage: Tiaptride tablet: For patients 5-12 yrs: 50mg bid for first 2 weeks, then 100 mg, bid for next 6 weeks; for patients 13-18 yrs:100mg bid for first 2 weeks, then 200 mg bid for next 6 weeks.

Mimic 5LGr Granule:Strength:0 gram/sack.Dosage:1 sack for patients less than 12 yrs,while 1.5 sacks for patients 13-18 yrs.Frequency: T.i.d.

Duration: 8 weeks.

Group Type ACTIVE_COMPARATOR

tiapride

Intervention Type DRUG

dosage form: tablet Strength:100 mg Dosage: For patients 5-12 yrs: 50mg bid for first 2 weeks, then 100 mg, bid for next 6 weeks; for patients 13-18 yrs:100mg bid for first 2 weeks, then 200 mg bid for next 6 weeks.

Total duration:8 weeks.

placebo, granule and tablet

This arm includes mimic preparation of 5LGr granule and tiapride tablets , which doesn't contain active ingredients.

Dosage form: Mimic Granule:Strength:0 gram/sack Dosage:1 sack, t.i.d for patients less than 12 yrs,while 1.5 sacks, t.i.d for patients 13-18 yrs.

Mimic tablet:Strength:0 mg/tablet.For patients 5-12 yrs: 0.5 tablets b.i.d for first 2 weeks, then 1 tablet,b.i.d for next 6 weeks; for patients 13-18 yrs:1 tablet b.i.d for first 2 weeks, then 2 tablets b.i.d for next 6 weeks.

Duration: 8 weeks.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

mimetic granule: same with 5LGr mimetic tablet: same with tiapride

Interventions

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5LGr

Dosage form:Granule Strength:5 gram/sack Dosage:1 sack for patients less than 12 yrs 1.5 sacks for patients 13-18 yrs. Frequency: three times per day. Duration: 8 weeks.

Intervention Type DRUG

tiapride

dosage form: tablet Strength:100 mg Dosage: For patients 5-12 yrs: 50mg bid for first 2 weeks, then 100 mg, bid for next 6 weeks; for patients 13-18 yrs:100mg bid for first 2 weeks, then 200 mg bid for next 6 weeks.

Total duration:8 weeks.

Intervention Type DRUG

placebo

mimetic granule: same with 5LGr mimetic tablet: same with tiapride

Intervention Type DRUG

Other Intervention Names

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Wuling Granule Tiapridel, Tiapridax Blank tablet

Eligibility Criteria

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Inclusion Criteria

* \>1 year history of diagnosed tic disorder;
* age:5-18 yrs;
* YGTSS score\>=30 at baseline.

Exclusion Criteria

* Diagnosed with hyperactivity disorder,epilepsy,chorea,autism,obsessive-compulsive disorder,mental retardation,athetosis,Wilson's disease.
* Any indefinite tic disorder or tic disorders caused by medication.
* Participation to other studies.
* Patients with loose stool.
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tasly Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xinmin Han, M.D.

Role: PRINCIPAL_INVESTIGATOR

Nanjing University of TCM affiliated hospital

Yi zheng

Role: PRINCIPAL_INVESTIGATOR

Capital Medical University

Minjie Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Nanjing Medical college Attached Brain Branch Hospital

Xiaowei Wei, M.D.

Role: PRINCIPAL_INVESTIGATOR

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Yan Cheng, M.D.

Role: PRINCIPAL_INVESTIGATOR

Second Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Xuefeng Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Yuyan Chen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Zhejiang University of TCM affiliated hospital

Ying Ding, M.D.

Role: PRINCIPAL_INVESTIGATOR

Henan University of TCM affiliated hospital

References

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Zheng Y, Zhang ZJ, Han XM, Ding Y, Chen YY, Wang XF, Wei XW, Wang MJ, Cheng Y, Nie ZH, Zhao M, Zheng XX. A proprietary herbal medicine (5-Ling Granule) for Tourette syndrome: a randomized controlled trial. J Child Psychol Psychiatry. 2016 Jan;57(1):74-83. doi: 10.1111/jcpp.12432. Epub 2015 Jun 13.

Reference Type DERIVED
PMID: 26072932 (View on PubMed)

Related Links

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http://www.tasly.com

Manufacturer

Other Identifiers

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NCT00797953

Identifier Type: -

Identifier Source: org_study_id