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The purpose of this study is to evaluate the effective and safety of 5LGr in pediatric patients with tic disorders.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5LGr, granule and placebo tablet | Experimental | 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. |
|
| tiapride tabletand mimic 5LGr granule | Active Comparator | 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. |
|
| placebo, granule and tablet | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5LGr | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Yale Global Tic Severity Scale(YGTSS) score change from baseline at 8 weeks | The outcome will be assessed at 8th weeks. And patients who judged as effective by investigator will be included in a follow-up period up to 4 weeks. | Within 8 weeks of completion intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of syndrome scales from baseline at 8 weeks; | Within 8 weeks of completion intervention. | |
| Change of YGTSS scores from baseline at 2 weeks; | within 2 weeks of intervention | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xinmin Han, M.D. | Nanjing University of TCM affiliated hospital | Principal Investigator |
| Yi zheng | Capital Medical University | Principal Investigator |
| Minjie Wang, M.D. | Nanjing Medical college Attached Brain Branch Hospital | Principal Investigator |
| Xiaowei Wei, M.D. | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine | Principal Investigator |
| Yan Cheng, M.D. | Second Teaching Hospital of Tianjin University of Traditional Chinese Medicine | Principal Investigator |
| Xuefeng Wang, M.D. | Affiliated Hospital of Liaoning University of Traditional Chinese Medicine | Principal Investigator |
| Yuyan Chen, M.D. | Zhejiang University of TCM affiliated hospital | Principal Investigator |
| Ying Ding, M.D. | Henan University of TCM affiliated hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26072932 | Derived | 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. |
| Label | URL |
|---|---|
| Manufacturer | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 10, 2015 | |
| Reset | Mar 19, 2015 | |
| Release | Nov 16, 2015 | |
| Reset | Dec 17, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 10, 2015 | Mar 19, 2015 | |||
| Nov 16, 2015 |
| ID | Term |
|---|---|
| D013981 | Tic Disorders |
| D005879 | Tourette Syndrome |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D065886 | Neurodevelopmental Disorders |
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| ID | Term |
|---|---|
| D063325 | Tiapride Hydrochloride |
| ID | Term |
|---|---|
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D001549 | Benzamides |
| D001565 |
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|
| tiapride | 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 | Drug | mimetic granule: same with 5LGr mimetic tablet: same with tiapride |
|
|
| Change of syndrome scales from baseline at 2 weeks; |
| Within 2 weeks of intervention |
| Dec 17, 2015 |
| D001523 | Mental Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |