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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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ITMCTR |
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Last refreshed on:
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20 February 2023 |
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Main ID: |
ITMCTR2100005418 |
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Date of registration:
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2021-12-17 |
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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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Observation of clinical efficacy of Ying-Pi No.1 hand mask cream in the treatment of scleroderma
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Scientific title:
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Observation of clinical efficacy of Ying-Pi No.1 hand mask cream in the treatment of scleroderma |
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Date of first enrolment:
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2019-10-01 |
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Target sample size:
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Test group:30;Control group:30; |
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Recruitment status: |
Completed |
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URL:
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http://itmctr.ccebtcm.org.cn/en-US/Home/ProjectView?pid=755f4970-ae33-441e-99a8-ff9c27831dcc |
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Study type:
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Interventional study |
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Study design:
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Quasi-randomized controlled
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Phase:
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0
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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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Xu Liping
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Address:
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No. 54 Youdian Road, Shangcheng District, Hangzhou, Zhejiang
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Telephone:
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13819116384 |
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Email:
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yuqian920920@126.com |
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Affiliation:
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Name:
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Xu Liping
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Address:
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No. 54 Youdian Road, Shangcheng District, Hangzhou, Zhejiang
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Telephone:
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13819116384 |
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Email:
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yuqian920920@126.com |
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Affiliation:
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The First Affiliated Hospital of Zhejiang Chinese Medical University |
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients who met the SSc classification diagnostic criteria of The American College of Rheumatology (ACR) in 2013(score 9 points) and whose skin involvement was in the stage of swelling and sclerosis.
Exclusion criteria: Patients with important organ involvement, such as pulmonary interstitial disease, pulmonary hypertension, pericardial effusion or hypertrophic inflammatory myopathy, need more than 0.5mg/kg/day glucocorticoid treatment; Patients with renal crisis; Patients with arteriovenous thrombosis and diabetes-related gangrene; Patients with SSC-related gangrene infection; Local skin is extensively damaged and cannot be applied externally.
Age minimum:
28
Age maximum:
78
Gender:
Both
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Health Condition(s) or Problem(s) studied
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scleroderma
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Intervention(s)
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Test group:MTX+ Alprostadil injection + Guipiperate maleate injection + Ying-Pi No.1 hand mask cream for external application;Control group:MTX+ Alprostadil injection + Guipiperate maleate injection;
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Primary Outcome(s)
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mRSS;Number of loops Input branch diameter output branch diameter top diameter of loop length of loop malformation ratio number of shallow corrugated nipples;
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Secondary ID(s)
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ChiMCTR2100005418
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ChiCTR2100054434
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Source(s) of Monetary Support
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the Traditional Chinese Medical Science and Technology Project of Zhejiang Province
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Ethics review
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Status: Approved
Approval date: 10/09/2019
Contact:
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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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