A Phase 2/3 interventional study of Guazuma Ulmifolia plus Tecoma Stans and Calcinaned magnesia in Type 2 Diabetes Mellitus, sponsored by Centro Universitario de Ciencias de la Salud, Mexico. Completed. Open to participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-10-18.
Sponsored by Centro Universitario de Ciencias de la Salud, Mexico · Phase 2/3, Interventional, and Treatment
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.
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, BMI, waist circumference, a metabolic profile (fasting glucose, HbA1c, lipids and biosecurity profile), were measured. The patients were randomly assigned to receive the herbarium mixture (GU/TS) 1 g before each meal, or placebo for a period of 90 days. All patients received therapy medical nutrition.
Exclusion Criteria:
The patients were randomly assigned to received placebo (calcinaned magnesia), 1 capsule before each meal for a period of 90 days.
Drug: Calcinaned magnesia
The patients were randomly assigned to received the herbarium mixture (GU/TS) , 1 capsule of 400mg, before each meal for a period of 90 days.
Drug: Guazuma Ulmifolia plus Tecoma Stans
Guazuma ulmifolia (313.6 mg) -Tecoma stans (86.4 mg) = 400 mg per capsule
Also known as: GUATECO
Calcined magnesia 400 mg per capsule
Also known as: Placebo
Modification in fasting glucose in patients with type 2 diabetes after of administration of combination with Guazuma ulmifolia and Tecoma stans
In both groups (intervention and placebo ) of 20 patients each , all patients with type 2 diabetes mellitus, glucose was measured in mg/dL, before and after the administration of the combination guazuma ulmifolia (313.6 mg) and tecoma stans (86.4 mg), one capsule before each food for a period of 90 days. The patient was on a 12-hour fast.
Time frame: 90 days
Modification in HbA1c in patients with type 2 diabetes after of administration of combination with Guazuma ulmifolia and Tecoma stans
In both groups (intervention and placebo ) of 20 patients each , all patients with type 2 diabetes mellitus, HbA1c was measured in %, before and after the administration of the combination guazuma ulmifolia (313.6 mg) and tecoma stans (86.4 mg), one capsule before each food for a period of 90 days. The patient was on a 12-hour fast.
Time frame: 90 days
Change in lipid profile in patients with type 2 diabetes after of administration of combination with Guazuma ulmifolia and Tecoma stans
In both groups (intervention and placebo ) of 20 patients each , all patients with type 2 diabetes mellitus, lipid profile was measured in mg/dL, before and after the administration of the combination guazuma ulmifolia (313.6 mg) and tecoma stans (86.4 mg), one capsule before each food for a period of 90 days. The patient was on a 12-hour fast.
Time frame: 90 days
Modification in insulin in patients with type 2 diabetes after of administration of combination with Guazuma ulmifolia and Tecoma stans
In both groups (intervention and placebo ) of 20 patients each, all patients with type 2 diabetes mellitus, insulin was measured in uU/mL, before and after the administration of the combination guazuma ulmifolia (313.6 mg) and tecoma stans (86.4 mg), one capsule before each food for a period of 90 days. The patient was on a 12-hour fast.
Time frame: 90 days
Hepatic safety of administration of guazuma, tecoma through the determination of hepatic profile
The hepatic profile was determined through the serum levels of transaminases in U/L (Glutamic oxalacetic transaminase and Glutamic pyruvic transaminase) after of administration during 90 days of the combination guazuma ulmifolia (313.6 mg) and tecoma stans (86.4 mg). The patient was on a 12-hour fast.
Time frame: 90 days
Renal safety of administration of guazuma, tecoma through the determination of serum creatinine
The serum creatinine was measured in mg/dL, before and after of administration during 90 days of the combination guazuma ulmifolia (313.6 mg) and tecoma stans (86.4 mg). The patient was on a 12-hour fast.
Time frame: 90 days
No study locations are listed for this record.
Plan to share: No
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Centro Universitario de Ciencias de la Salud, Mexico