An interventional study of Vitamin B5 Tablets and placebo in Inflammatory Bowel Diseases, sponsored by Changhai Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-06-15.
Sponsored by Changhai Hospital · Not applicable, Interventional, and Treatment
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.
963 studies on the registry are indexed under Intestinal Diseases; 174 are open to participants now.
This study's planned enrollment of 100 is above the median of 70 across 552 interventional studies indexed under Intestinal Diseases.
Browse Intestinal Diseases studies →Changhai Hospital is the lead sponsor of 342 studies on the registry; 133 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Based on the standard IBD treatment, Vitamin B5 (5mg/tablet) is given orally three times a day, four tablets each time, for 12 weeks.
Drug: Vitamin B5 Tablets
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.
Drug: placebo
The experimental group was given Vitamin tablets (5mg/tablet) based on the standard IBD treatment.
The control group was given placebo tablets of the same type based on the standard IBD treatment.
Clinical remission rate
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.
Time frame: Through study completion, an average of 12 months.
Disease activity score of IBD patients
Modified Mayo score or CDAI score
Time frame: Through study completion, an average of 12 months.
Histological remission
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.
Time frame: Through study completion, an average of 12 months.
Clinical response
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.
Time frame: Through study completion, an average of 12 months.
Plan to share: No
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Changhai Hospital