Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT06899620
Eligibility Criteria:
* Inclusion Criteria:
1. Participants must be aged between 18 and 65 years.
2. They should have a documented history of long-term alcohol consumption, defined as consuming at least 20 grams of ethanol per day for at least one year. This is calculated using the formula: volume (mL) × alcohol content (%) × 0.8.
3. They must provide written informed consent and be willing to comply with the study procedures.
* Exclusion Criteria:
1. History of chronic liver, gastrointestinal, or systemic metabolic disorders.
2. Use of products with similar functions to the investigational formulation within the past two weeks.
3. Use of antibiotics, laxatives, or dietary supplements within the past four weeks.
4. Documented history of hypertension or diabetes.
5. Severe allergies or immune deficiencies.
6. Pregnancy, lactation, or planning pregnancy without effective contraception during the study period.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06899620
Study Brief:
Protocol Section:
NCT06899620