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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: |
ITMCTR2100004997 |
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Date of registration:
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2021-06-28 |
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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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Clinical and basic research of therapy with sinomenine for pimary membranous nephropathy
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Scientific title:
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Clinical and basic research of therapy with sinomenine for pimary membranous nephropathy |
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Date of first enrolment:
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2021-07-01 |
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Target sample size:
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control group:80;experimental group:80; |
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Recruitment status: |
Pending |
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URL:
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http://itmctr.ccebtcm.org.cn/en-US/Home/ProjectView?pid=8c573c8a-b43c-49db-acbd-5257bae8fa39 |
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Study type:
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Interventional study |
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Study design:
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Parallel
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Phase:
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4
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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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Liu Liang
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Address:
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Avenida Wai Long, Taipa, Macau, China
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Telephone:
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+86 15920798553 |
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Email:
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lliu@must.edu.mo |
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Affiliation:
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Macau University of Science and Technology |
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Name:
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Li Xuexia
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Address:
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208 Gongbeiyuehua Road, Xiangzhou District, Zhuhai, Guangdong
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Telephone:
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+86 15018342882 |
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Email:
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sitalisa@163.com |
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Affiliation:
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Zhuhai Hospital of Intergrative Chinese and Western Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. PMN adults diagnosed by renal biopsy regardless of gender and nation;
2. PMN patients among low risk group and middle risk group without risk factors;
3. Signed Informed Consent;
4. No usage of glucocorticoid or immunosuppressives within 3 months.
Exclusion criteria: 1. PMN patients among high risk and very high risk group,or middle risk group with risk factors.
2. Infection,pregnant,trauma;
3. Serious systemic diseases;
4. Hematological sysyten diseases;
5. Allergic to Sinomenine;
6. Younger than 18 years old;
7. Attending other clinical trial.
Age minimum:
18
Age maximum:
70
Gender:
Both
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Health Condition(s) or Problem(s) studied
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PRIMARY MEMBRANOUS NEPHROPATHY
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Intervention(s)
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control group:Placebo 120mg orally intake twice a day;experimental group:Sinomenine 120mg orally intake twice a day;
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Primary Outcome(s)
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Immune cells;Serum albumin;24h urine protein quantitation;Glomerular filtration rate;
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Secondary ID(s)
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ChiCTR2100047996
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ChiMCTR2100004997
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Source(s) of Monetary Support
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Macau Science and Technology Development Fund
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Ethics review
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Status: Approved
Approval date: 09/06/2021
Contact:
Li Min
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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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