Clinical Study of Vitamin B5 in Adjuvant Treatment of IBD

Naval Military Medical University

Status: Enrolling

Conditions: Inflammatory Bowel Diseases

Treatments: Drug: placebo; Drug: Vitamin B5 Tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT05701501

VitB5

Details and patient eligibility

About

Patients with IBD are randomized to oral administration of vitamin B5 and placebo based on the standard treatment, exploring whether Vitamin B5 can increase the clinical remission rate of IBD patients and improve the treatment effect.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with IBD according to the consensus on the diagnosis and treatment of inflammatory bowel disease (Beijing, 2018, DOI:10.19538/j.nk2018090106);
• Have complete medical history data;
• Volunteer to participate in this clinical trial and sign the informed consent form.

Exclusion criteria

• Hemophilic patients;
• There are abdominal abscesses, toxic megacolon, fulminant colitis, partial colectomy, or total colectomy;
• Other autoimmune diseases, hematological diseases, tumors, acute infection, severe liver and kidney insufficiency, serious diseases such as severe anemia, neutropenia, heart failure, organic heart disease, hepatitis B, liver cirrhosis, kidney disease and mental diseases;
• Take calcium pantothenate preparation in recent 3 months;
• Have a history of abuse of psychoactive substances;
• Pregnant or lactating women, or plan to be pregnant in the next 6 months;
• Nervous system diseases: such as Alzheimer's disease, stroke, Parkinson's disease;
• Participate in other clinical trials in the past 6 months;
• Incomplete medical record information (including gender, age, diagnosis information, colonoscopy results, pathological diagnosis results and other demographic data)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Vitamin B5 group

Experimental group

Description:

Based on the standard IBD treatment, Vitamin B5 (5mg/tablet) is given orally three times a day, four tablets each time, for 12 weeks.

Treatment:

Drug: Vitamin B5 Tablets

Control group

Placebo Comparator group

Description:

Based on the standard IBD treatment, the same type of placebo tablets are given orally three times a day, four tablets each time, for 12 weeks.

Treatment:

Drug: placebo