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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-TRC-10000947 |
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Date of registration:
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2010-07-27 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A study of Traditional Chinese medicine "Bian Zheng Lun Zhi" in the treatment of patients with Hand, Foot and Mouth Disease complicated with central nerve system infection
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Scientific title:
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A study of Traditional Chinese medicine "Bian Zheng Lun Zhi" in the treatment of patients with Hand, Foot and Mouth Disease complicated with central nerve system infection |
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Date of first enrolment:
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2010-07-01 |
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Target sample size:
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A:110;B:110;C:110; |
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Recruitment status: |
Completed |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=8591 |
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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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Post-market
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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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Shengxian Wu
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Address:
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No. 5, Hai Yun Chang, East Distric, Beijing
100700
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Telephone:
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+86 010 84015528 |
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Email:
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wushx@sina.com |
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Affiliation:
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Dong Zhi Men Hospital, Beijing University of Chinese Medicine |
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Name:
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Yongli Zhang
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Address:
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No. 8, Jing Sun Dong Street, Chaoyang District
100015
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Telephone:
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+86 010 84322009 |
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Email:
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bjdtyyxx@sina.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. To be accoding to the diagnostic standard of Ministry of Health "Hand, Foot and Mouth Disease diagnosis and treatment guideline, 2010";
2. To be according to the diagnostic standard of central system infection;
3. To be appeared the central system infection presentations within 48 hours;
4. aged 1 to 6 years old;
5. To be signed the informed consent.
Exclusion criteria: 1. Severe case with any one of following problems:
(1) frequently twitch, coma, hernia;
(2) difficult breathing, cyanotic, bloody sputum bubble, Pulmonary rales;
(3) Cycle dysfunction includes shock;
2. Complicated with epilepsy, tumur, congenital heart disease, kidney disease adn genetic metabolic diseases;
3. Febrile convulsions;
4. Using or long term use hormone for basic diseases;
5. Patient is attending other clinical study of Hand, Foot, Mouth Disease;
6. other patients who to be considered not suit for inclusion.
Age minimum:
1
Age maximum:
6
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hand, Foot and Mouth Disease
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B08.401
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Intervention(s)
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A:Convention medicine;B:Conventional medicine + Tan Re Qing injection;C:Conventional medicine + Tan Re Qing injection + or;
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Primary Outcome(s)
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Mortality;Time of fever clearance;Rate of worsing case;
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Secondary Outcome(s)
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Stable time of disease;Adverse event;Consuming of hormone or dehydrating agents;
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Source(s) of Monetary Support
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Chinese Medicine Administration of Beijing City
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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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