Status:
COMPLETED
Effect of Oral Administration of a Herbarium Mixture (Guazuma Ulmifolia and Tecoma Stans) on Metabolic Profile in Type 2 Diabetic Patients
Lead Sponsor:
Centro Universitario de Ciencias de la Salud, Mexico
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
30-65 years
Phase:
PHASE2
PHASE3
Brief Summary
To evaluate the effect of oral administration of herbarium mixture Guazuma ulmifolia (GU) and Tecoma stans (TS) on metabolic profile in type 2 diabetic patients.
Detailed Description
A randomized, double blind, placebo controlled, clinical trial was carried out 40 type 2 diabetic patients independently of their basal hypoglycemic treatment. At beginning and at end of the study, BM...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 10 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03313856
Start Date
January 10 2010
End Date
May 31 2011
Last Update
October 18 2017
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