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:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT03313856
Eligibility Criteria:
Inclusion Criteria:
* Signing of letter of consent under written information.
* Men and women with serum glucose of ≥126 and \<400 mg / dl and / or HbA1c ≥6.5% and \<10%.
* Age between 30 and 60 years.
* BMI between 25 - 39.9 kg / m2.
* With or without pharmacological treatment with oral hypoglycemic agents or insulin
* Stable body weight during the last 3 months (± 5%).
* Women in the follicular phase of the menstrual cycle (days 3 to 8 of the cycle) at the time of the laboratory tests
* Women who do not expect to be pregnant within the next 3 months.
Exclusion Criteria:
* Physical or mental incapacity that makes it impossible to carry out the intervention.
* Uncontrolled thyroid disease
* Women with suspicion or confirmation of pregnancy.
* Women who are breastfeeding.
* Hepatic disease or elevation to double the upper normal value of TGO and TGP.
* Diagnosis of renal insufficiency or creatinine\> 1.5 mg / dL or glomerular filtration rate \<60 mL / min).
* Known hypersensitivity to calcined magnesia or Guazuma ulmifolia and / or Tecoma stans.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT03313856
Study Brief:
Protocol Section:
NCT03313856