Trial · NCT05574036
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in fibrosis stage; fibrosis improvement (≥ 1 stage), with no worsening of NASH, detected by fibroscan device | 6 months | Patients will undergo fibroscan testing prior to the initiation of the intervention and after 6 months of receiving the drug therapy to detect fibrosis improvement |
| Primary | Change from baseline NASH condition at 6 months; NASH resolution, with no worsening of fibrosis, with the study considered successful if either 1ry end point is met. | 6 months | Patients will undergo assessment of serum aminotransferases prior to the initiation of the intervention and after 6 months of receiving the drug therapy to detect NASH resolution |
| Primary | Change from baseline steatosis stage at 6 months detected by Fibroscan device | 6 months | Patients will undergo fibroscan testing prior to the initiation of the intervention and after 6 months of receiving the drug therapy to detect steatosis improvement |
| Secondary | Change in serum level of Nucleotide-binding and oligomerization domain (NOD-like) receptor family pyrin domain containing 3 inflammasome(NLRP3) | 6 months | Blood samples will be collected at baseline and after 6 months of receiving the intervention therapy to evaluate NODlike receptor family pyrin domain containing 3 inflammasome(NLRP3) |
| Secondary | Change in serum level of Malondialdehyde (MDA) | 6 months | Blood samples will be collected at baseline and after 6 months of receiving the intervention therapy to evaluate Malondialdehyde (MDA) |
| Secondary | Change in serum uric acid | 6 months | Blood samples will be collected at baseline and after 6 months of receiving the intervention therapy to evaluate serum uric acid |
| Secondary | Change in fasting insulin with calculation of Homeostasis Model Assessment (HOMA-IR). | 6 months | Blood samples will be collected at baseline and after 6 months of receiving the intervention therapy to evaluate fasting insulin with calculation of Homeostasis Model Assessment (HOMA-IR). |
| Secondary | Change in serum level of cytokeratin-18 (CK-18) | 6 months | Blood samples will be collected at baseline and after 6 months of receiving the intervention therapy to evaluate cytokeratin-18 (CK-18) |
| Secondary | Change in serum level of Total lipid profile (Total cholesterol, High density lipoprotein cholesterol and Triglycerides) with calculation of Low density lipoprotein. | 6 months | Blood samples will be collected at baseline and after 6 months of receiving the intervention therapy to evaluate Total cholesterol, High density lipoprotein cholesterol and Triglycerides with calculation of Low density lipoprotein. |
| Secondary | Change in serum level of Liver enzymes; Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alk.Phosphatase (ALP) and Gamma-glutamyl transferase (GGT) | 6 months | Blood samples will be collected at baseline and after 6 months of receiving the intervention therapy to evaluate Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alk. Phosphatase (ALP) and Gamma-glutamyl transferase (GGT) |
| Secondary | Change in serum level of tissue inhibitor of metalloproteinase-1 (TIM-1) | 6 months | Blood samples will be collected at baseline and after 6 months of receiving the intervention therapy to evaluate tissue inhibitor of metalloproteinase-1(TIM-1) |
| Secondary | Change in serum urea and creatinine. | 6 months | Blood samples will be collected at baseline and after 6 months of receiving the intervention therapy to evaluate Serum urea and creatinine. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT05574036/registered