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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: |
ITMCTR2000003714 |
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Date of registration:
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2020-08-25 |
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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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Study of Jianpi Huashi Decoction and Mesalazine on Ulcerative Colitis Patients with Spleen Deficiency and Damp-Heat Type
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Scientific title:
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Study of Jianpi Huashi Decoction and Mesalazine on Ulcerative Colitis Patients with Spleen Deficiency and Damp-Heat Type |
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Date of first enrolment:
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2020-10-01 |
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Target sample size:
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Mesalazine Group:45;Jianpi Huashi Decoction Group:45; |
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Recruitment status: |
Recruiting |
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URL:
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http://itmctr.ccebtcm.org.cn/en-US/Home/ProjectView?pid=6bdd0e59-5ea0-4a48-9d49-5d6529b7c692 |
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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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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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Qinwei Zheng
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Address:
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110 Ganhe Road, Hongkou District, Shanghai, China
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Telephone:
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+86 13795292920 |
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Email:
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violazheng228@126.com |
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Affiliation:
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Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of TCM |
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Name:
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Weiwei Hao
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Address:
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110 Ganhe Road, Hongkou District, Shanghai, China
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Telephone:
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+86 021-65161782 |
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Email:
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hwwwork@163.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. According to the diagnostic criteria of Western medicine for ulcerative colitis, the clinical severity is mild to moderate; the lesions include rectum, left colon or extensive colon; the clinical types are primary or chronic relapse;
2. TCM syndrome differentiation belongs to spleen deficiency damp heat type;
3. They are between 18 and 75 years old;
4. The patient voluntarily participated in the clinical trial and signed the informed consent.
Exclusion criteria: 1. Patients with chronic persistent, fulminant and severe ulcerative colitis.
2. Patients with infectious colitis such as bacillary dysentery, amebic dysentery, chronic schistosomiasis, intestinal tuberculosis, Crohn's disease, ischemic enteritis and radiation enteritis.
3. Patients have serious complications, such as local stenosis, intestinal perforation, intestinal obstruction, massive hemorrhage, toxic megacolon, colorectal cancer and so on.
4. Combined with heart, liver, kidney, hematopoietic system, endocrine system and other serious primary diseases and mental patients.
5. Pregnant or preparing pregnant women, lactating women, allergic constitution and allergic to this drug.
6. Those who have been treated with hormone therapy or other related drugs or are participating in other clinical trials.
7. Suspected or confirmed history of alcohol and drug abuse.
8. Those who do not cooperate with the treatment and cannot judge the curative effect.
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Uicerative colitis
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Intervention(s)
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Mesalazine Group:Mesalazine;Jianpi Huashi Decoction Group:Jianpi Huashi Decoction;
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Primary Outcome(s)
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clinical efficacy rate;
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Secondary Outcome(s)
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laboratory index;endoscopic response rate;mucosal healing rate;quality of life;TCM syndrome efficacy;clinical remission rate;emotion evaluation;
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Secondary ID(s)
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ChiCTR2000036950
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ChiMCTR2000003714
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Source(s) of Monetary Support
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Shanghai Health Committee, Shanghai Administration of traditional Chinese Medicine
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Ethics review
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Status: Approved
Approval date: 11/08/2020
Contact:
Congquan Yin
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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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