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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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18 April 2017 |
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Main ID: |
ChiCTR-IOR-14005674 |
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Date of registration:
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2014-12-09 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Open randomized controlled trial of the Jianpi Yifei Decoction in the treatment of bulbar paralysis of amyotrophic lateral sclerosis
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Scientific title:
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Open randomized controlled trial of the Jianpi Yifei Decoction in the treatment of bulbar paralysis of amyotrophic lateral sclerosis |
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Date of first enrolment:
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2014-12-30 |
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Target sample size:
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Chinese medicine :30;Riluzole:30; |
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Recruitment status: |
Pending |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=10035 |
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Study type:
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Interventional study |
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Study design:
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Randomized parallel controlled trial
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Phase:
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Other
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Countries of recruitment
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China
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Contacts
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Name:
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Du Baoxin
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Address:
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No. 111, Dade Road, Guangzhou
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Telephone:
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+86 13760741846 |
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Email:
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yang_biying@126.com |
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Affiliation:
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Guangdong Province Traditional Chinese Medical Hospital |
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Name:
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Du Baoxin
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Address:
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No. 111, Dade Road, Guangzhou
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Telephone:
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+86 13760741846 |
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Email:
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yang_biying@126.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. At the age of 18 years old and above, not limited to men and women;
2. Meet the diagnostic criteria for ALS diagnosis / probable;
3. The patients' informed consent to accept the trial;
4. Women must not be able to become pregnant for the duration of the study. Women of childbearing potential must have a negative pregnancy test at screening and be non-lactating.
Exclusion criteria: 1. Have allergy history of Jianpi Yifei Decoction;
2. Associated with other serious diseases including liver, kidney, cardiovascular disease;
3. Combined with mental illness or severe neurosis patients;
4. Unable to express subjective symptoms;
5. Clinical evidence of unstable medical or psychiatric illness in the investigator's judgment.
Age minimum:
18
Age maximum:
80
Gender:
Both
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Health Condition(s) or Problem(s) studied
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amyotrophic lateral sclerosis
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Intervention(s)
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Chinese medicine :Jianpi Yifei Decoction ;Riluzole:Riluzole;
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Primary Outcome(s)
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Water swallow test;Frenchay dysarthria assessment;The ALSFRS-R scale;Swallowing angiography;Strobe laryngoscope;
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Secondary Outcome(s)
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liver function;Creatinine;
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Source(s) of Monetary Support
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dedicated study foundation of Guangdong Province Traditional Chinese Medical Hospital
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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