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Sodium Hyaluronate for Non-Alcoholic Fatty Liver Disease

Phase < 1
Recruiting
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Alcohol consumption of less than 7 drinks per week for women and less than 14 drinks per week for men
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 4
Awards & highlights

Study Summary

This trial is testing a new treatment for non-alcoholic fatty liver disease. Subjects will take a placebo or treatment for 3 days, then participate in a study visit that includes medical exams, questionnaires, and body measurements. They will also consume a sugar cocktail and participate in an acute ethanol challenge. Two muscle biopsies will be taken. The trial will take 3-4 hours.

Who is the study for?
This trial is for healthy individuals who drink alcohol moderately (up to 7 drinks per week for women and up to 14 for men). They must understand the study and consent in writing. People with uncontrolled diabetes, thyroid issues, hypertension, liver disease, heart problems, kidney failure, pregnancy, abnormal blood clotting or on certain medications like steroids or hormones cannot participate.Check my eligibility
What is being tested?
The trial tests Sodium Hyaluronate's effects compared to a placebo over three days followed by assessments including medical exams and muscle biopsies after an acute ethanol challenge. Participants will also measure gut permeability using a sugar cocktail.See study design
What are the potential side effects?
While specific side effects of Sodium Hyaluronate aren't detailed here, participants may experience discomfort from procedures such as muscle biopsies and potential reactions from the acute ethanol challenge.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I drink less than 7 (if woman) or 14 (if man) alcoholic drinks per week.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Alanine Aminotransferase (ALT)
Change in Aspartate Aminotransferase (AST)

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: HA35 Treatment GroupActive Control1 Intervention
12 study participants will be given an HA35 capsule to take once per day in the morning with breakfast for 3 days.
Group II: HA35 Placebo GroupPlacebo Group1 Intervention
12 study participants will be given a placebo capsule to take once per day in the morning with breakfast for 3 days.

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,027 Previous Clinical Trials
1,364,254 Total Patients Enrolled

Media Library

Placebo (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05025865 — Phase < 1
Healthy Controls Research Study Groups: HA35 Treatment Group, HA35 Placebo Group
Healthy Controls Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05025865 — Phase < 1
Placebo (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05025865 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What circumstances does the HA35 Treatment Group typically address?

"HA35 Treatment Group is an efficient option for managing skin irritation, joint inflammation in the case of osteoarthritis (OA), and dermabrasion."

Answered by AI

Am I eligible to join this experiment?

"In order to be accepted into this trial, potential participants must have a healthy control group and fall within the 21-65 age range. Approximately 24 individuals will be admitted in total."

Answered by AI

Is the enrollment of participants over 18 years old permitted within this experiment?

"This study is only open to those aged 21-65. Alternatively, there are 3 trials for minors and 17 specifically designed for people over the age of 65."

Answered by AI

How many individuals have chosen to participate in this medical research?

"Indeed, the information found on clinicaltrials.gov confirms that this research effort is actively seeking participants. Launched in February 1st 2022 and last updated at May 5th 2022, it plans to recruit 24 individuals from one single site."

Answered by AI

What additional research has been done to explore the efficacy of HA35 Treatment Group?

"Presently, 16 clinical trials for HA35 Treatment Group are ongoing. Of these studies, 4 have reached Phase 3. Most of the research is conducted in Morgantown, West virginia but 31 medical centres across the nation are participating."

Answered by AI

Is the enrollment period for this research study currently open?

"That is correct. According to the details hosted on clinicaltrials.gov, this medical trial was initially posted in February 1st 2022 and has been actively seeking participants ever since. The research project requires 24 individuals from one location for completion."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
HA35 Acute Alcohol Study
Srinivasan Dasarathy 2022. "HA35 Acute Alcohol Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05025865.
~9 spots leftby Oct 2025
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