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Efficacy and Safety of Thalidomide Combined With Glutamine in the Treatment of Radiation Intestinal Injury: a Single-center, Open-label, Randomized Controlled Study
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.
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.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
Start Date
September 30, 2024
Primary Completion Date
October 1, 2025
Completion Date
October 1, 2026
Last Updated
October 1, 2024
150
ESTIMATED participants
Thalidomide
DRUG
Glutamine
DRUG
Thalidomide+Glutamine
DRUG
Lead Sponsor
Yongquan Shi
NCT03516461
NCT06836960
NCT07331688
Data Source & Attribution
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