Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
220 participants
INTERVENTIONAL
2024-06-01
2025-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Experimental：VitaminB6 group
Based on the standard treatment，VitaminB6 （10mg/tablet）is given orally once a day,one tablet each time,for 3 weeks.
Vitamin B6 Tablets
The experimental group was given a Vitamin B6 tablet（10mg/tablet）once a day for 3weeks, besides of the standard IBD treatment.
Placebo
The control group was given a placebo tablet on the same type once a day for 3weeks, besides of the standard IBD treatment.
Placebo Comparator:Control group
Based on the standard treatment，the same type of placebo tablets are given orally once a day,one tablet each time,for 3 weeks.
Vitamin B6 Tablets
The experimental group was given a Vitamin B6 tablet（10mg/tablet）once a day for 3weeks, besides of the standard IBD treatment.
Placebo
The control group was given a placebo tablet on the same type once a day for 3weeks, besides of the standard IBD treatment.
Interventions
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Vitamin B6 Tablets
The experimental group was given a Vitamin B6 tablet（10mg/tablet）once a day for 3weeks, besides of the standard IBD treatment.
Placebo
The control group was given a placebo tablet on the same type once a day for 3weeks, besides of the standard IBD treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have complete medical history data;
* Volunteer to participate in this clinical trial and sign the informed consent form.
Exclusion Criteria
* Patients with abdominal abscess, toxic megacolon, fulminant colitis, partial colectomy, or total colectomy;
* Patients with other autoimmune diseases, hematologic disorders, tumors, acute infections, severe liver or kidney dysfunction, severe conditions such as severe anemia, neutropenia, heart failure, organic heart disease, hepatitis B, cirrhosis, kidney disease, and psychiatric disorders;
* Patients who have taken vitamin B6 tablets in the past 3 months;
* Patients with a history of substance abuse;
* Pregnant or lactating women, or those planning to become pregnant within the next 6 months;
* Neurological disorders such as Alzheimer's disease, stroke, Parkinson's disease;
* Participation in other clinical trials in the past 6 months;
* Incomplete medical records (including gender, age, diagnosis, colonoscopy results, pathological diagnosis results, and other demographic data);
* Currently taking: levodopa, phenobarbital, phenytoin sodium.
18 Years
75 Years
ALL
No
Sponsors
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Changhai Hospital
OTHER
Responsible Party
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Zhaoshen Li
professor
Principal Investigators
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Zhaoshen Li
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Naval Medical University
Shu Zhu
Role: STUDY_DIRECTOR
The University of Science and Technology of China
Locations
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Changhai Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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VitB6
Identifier Type: -
Identifier Source: org_study_id
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