Inflammatory Bowel Diseases
Conditions
Keywords
Vitamin B5,treatment
Brief summary
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.
Interventions
DRUGVitamin B5 Tablets
The experimental group was given Vitamin tablets (5mg/tablet) based on the standard IBD treatment.
DRUGplacebo
The control group was given placebo tablets of the same type based on the standard IBD treatment.
Sponsors
The University of Science and Technology of China
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical remission rate | Through study completion, an average of 12 months. | To evaluate the improvement effect of clinical remission rate (Mayo score ≤ 2 points and no single sub-score\>1 point; CDAI score\<150) in IBD patients after 12 weeks of oral Vitamin B5 while taking routine treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease activity score of IBD patients | Through study completion, an average of 12 months. | Modified Mayo score or CDAI score |
| Histological remission | Through study completion, an average of 12 months. | Based on the Geboes scale. No or slight increase of chronic inflammatory infiltration in lamina propria, no neutrophils in lamina propria or epithelium, no persistent clinical response of erosion, ulcer or granulation tissue. |
| Clinical response | Through study completion, an average of 12 months. | Modified Mayo score decreased by 2 points and 30% from baseline+rectal bleeding score decreased by 1 point or absolute rectal bleeding score decreased by 1 point. |
Countries
China
Contacts
Primary ContactZhaoshen Li, PhD, MD
Outcome results
None listed