Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619808
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-11
Brief Title:
Hyperbaric Oxygen Therapy for Metabolic Dysfunction-associated Steatotic Liver Diseases
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of Hyperbaric Oxygen Therapy in Adult Metabolic Dysfunction-associated Steatotic Liver Diseases MASLD Patients a Randomized Controlled Trial
Status:
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:
MASLD
Brief Summary:
The goal of this clinical trial is to learn if hyperbaric oxygen therapy HBOT works to treat Metabolic Dysfunction-associated Steatotic Liver Diseases MASLD The main questions it aims to answer are
Does HBOT decreases the fat content and fibrosis state of liver in adult MASLD patients Does HBOT improves the liver function and metabolic condition in adult MASLD patients
Participants will
Receive HBOT for 20 times in 1 month or recerive regular drug Visit the clinic for checkups and tests at the starting ending of the therapy and 6 month after the therapy
Does HBOT decreases the fat content and fibrosis state of liver in adult MASLD patients Does HBOT improves the liver function and metabolic condition in adult MASLD patients
Participants will
Receive HBOT for 20 times in 1 month or recerive regular drug Visit the clinic for checkups and tests at the starting ending of the therapy and 6 month after the therapy
Detailed Description:
Metabolic Dysfunction-associated Steatotic Liver Diseases MASLD patients who meet our principles would be randomized into 2 groups the HBOT group and CON group The entire project is not blinded In HBOT group participants will receive HBOT for 20 times in 1 month 20ATA 60min which is the common setting in clinical useThe CON group which means the control group recerives regular drug like liver-protective drugs and hypoglycemic drugs The visiting times are week 0 starting of the project week 4 ending of the therapy week 28 6 months after the therapy when participants get checkups and tests The primary outcome of our study are the change of liver fat content and stiffness in Fibroscan The secondary outcomes invovle changes of liver function enzymes and metabolism
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