Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The University of Science and Technology of China | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin B5 group | Experimental | Based on the standard IBD treatment, Vitamin B5 (5mg/tablet) is given orally three times a day, four tablets each time, for 12 weeks. |
|
| Control group | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin B5 Tablets | Drug | The experimental group was given Vitamin tablets (5mg/tablet) based on the standard IBD treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, an average of 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease activity score of IBD patients | Modified Mayo score or CDAI score | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhaoshen Li, PhD, MD | Contact | +86-21-25070552 | zhaoshenlismmu@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhaoshen Li, MD | Changhai Hospital | Principal Investigator |
| Shu Zhu, PhD | The University of Science and Technology of China | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Recruiting | Shanghai | 200433 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D010205 | Pantothenic Acid |
| ID | Term |
|---|---|
| D007094 | Imides |
| D009930 | Organic Chemicals |
| D015091 | beta-Alanine |
| D000409 | Alanine |
| D000596 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo | Drug | The control group was given placebo tablets of the same type based on the standard IBD treatment. |
|
| 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. | Through study completion, an average of 12 months. |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |