Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06617182
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
Efficacy and Safety of Thalidomide Combined With Glutamine in the Treatment of Radiation Intestinal Injury
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of Thalidomide Combined With Glutamine in the Treatment of Radiation Intestinal Injury a Single-center Open-label Randomized Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
At present there is still a lack of standard and effective treatment strategies and procedures for radiation intestinal injury Studies have shown that thalidomide can effectively treat refractory gastrointestinal bleeding caused by vascular malformation Therefore The investigators designed a single-center open-label randomized controlled study to evaluate the efficacy and safety of thalidomide combined with glutamine in the treatment of radiation intestinal injury
Detailed Description:
Screening This phase will not last longer than one week and the subject will be assessed for eligibility after signing the informed consent form
Treatment Subjects were randomly assigned to three different treatment groups for 8 weeks
Follow-up The subjects defecation status was recorded every day during treatment telephone follow-up was conducted every two weeks and laboratory indicators including blood routine stool routine etc were tested every four weeks The test was terminated one week after treatment and the improvement of subjects stool blood was assessed
Treatment Subjects were randomly assigned to three different treatment groups for 8 weeks
Follow-up The subjects defecation status was recorded every day during treatment telephone follow-up was conducted every two weeks and laboratory indicators including blood routine stool routine etc were tested every four weeks The test was terminated one week after treatment and the improvement of subjects stool blood was assessed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None