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 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT07151833
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 20-70 years.
* Diagnosed with type 2 diabetes mellitus (T2DM) based on ADA criteria.
* HbA1c ≥ 7%.
* At risk of diabetic foot ulcer (ABI \< 0.9 or early neuropathy signs).
* Willing to consume study cookies and comply with study protocol.
* Provided written informed consent.
Exclusion Criteria:
* Current use of herbal supplements or functional foods containing Gynura procumbens.
* Presence of active diabetic foot ulcer or severe infection.
* Severe cardiovascular, renal (eGFR \< 30 mL/min/1.73 m²), or hepatic impairment.
* Pregnancy or breastfeeding.
* Known allergy to ingredients in study cookies.
* Participation in another clinical trial within the last 3 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT07151833
Study Brief:
Protocol Section:
NCT07151833