Effect of Oral Administration of a Herbarium Mixture (Guazuma Ulmifolia and Tecoma Stans) on Metabolic Profile in Type 2 Diabetic Patients
NCT ID: NCT03313856
Last Updated: 2017-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
40 participants
INTERVENTIONAL
2010-01-10
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
The patients were randomly assigned to received placebo (calcinaned magnesia), 1 capsule before each meal for a period of 90 days.
Calcinaned magnesia
Calcined magnesia 400 mg per capsule
Guazuma ulmifolia plus Tecoma stans
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.
Guazuma Ulmifolia plus Tecoma Stans
Guazuma ulmifolia (313.6 mg) -Tecoma stans (86.4 mg) = 400 mg per capsule
Interventions
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Guazuma Ulmifolia plus Tecoma Stans
Guazuma ulmifolia (313.6 mg) -Tecoma stans (86.4 mg) = 400 mg per capsule
Calcinaned magnesia
Calcined magnesia 400 mg per capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
30 Years
65 Years
ALL
No
Sponsors
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Centro Universitario de Ciencias de la Salud, Mexico
OTHER
Responsible Party
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Maria Guadalupe Ramos Zavala
Clinical Professor
References
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Kaufman RJ. Beta-cell failure, stress, and type 2 diabetes. N Engl J Med. 2011 Nov 17;365(20):1931-3. doi: 10.1056/NEJMcibr1109442. No abstract available.
Saisho Y. beta-cell dysfunction: Its critical role in prevention and management of type 2 diabetes. World J Diabetes. 2015 Feb 15;6(1):109-24. doi: 10.4239/wjd.v6.i1.109.
Andrade-Cetto A, Heinrich M. Mexican plants with hypoglycaemic effect used in the treatment of diabetes. J Ethnopharmacol. 2005 Jul 14;99(3):325-48. doi: 10.1016/j.jep.2005.04.019.
Frei B, Baltisberger M, Sticher O, Heinrich M. Medical ethnobotany of the Zapotecs of the Isthmus-Sierra (Oaxaca, Mexico): documentation and assessment of indigenous uses. J Ethnopharmacol. 1998 Sep;62(2):149-65. doi: 10.1016/s0378-8741(98)00051-8.
Leonti M, Sticher O, Heinrich M. Medicinal plants of the Popoluca, Mexico: organoleptic properties as indigenous selection criteria. J Ethnopharmacol. 2002 Aug;81(3):307-15. doi: 10.1016/s0378-8741(02)00078-8.
Roman-Ramos R, Flores-Saenz JL, Partida-Hernandez G, Lara-Lemus A, Alarcon-Aguilar F. Experimental study of the hypoglycemic effect of some antidiabetic plants. Arch Invest Med (Mex). 1991 Jan-Mar;22(1):87-93.
Alonso-Castro AJ, Salazar-Olivo LA. The anti-diabetic properties of Guazuma ulmifolia Lam are mediated by the stimulation of glucose uptake in normal and diabetic adipocytes without inducing adipogenesis. J Ethnopharmacol. 2008 Jul 23;118(2):252-6. doi: 10.1016/j.jep.2008.04.007. Epub 2008 Apr 12.
Cano JH, Volpato G. Herbal mixtures in the traditional medicine of eastern Cuba. J Ethnopharmacol. 2004 Feb;90(2-3):293-316. doi: 10.1016/j.jep.2003.10.012.
Alarcon-Aguilara FJ, Roman-Ramos R, Perez-Gutierrez S, Aguilar-Contreras A, Contreras-Weber CC, Flores-Saenz JL. Study of the anti-hyperglycemic effect of plants used as antidiabetics. J Ethnopharmacol. 1998 Jun;61(2):101-10. doi: 10.1016/s0378-8741(98)00020-8.
Eddouks M, Bidi A, El Bouhali B, Hajji L, Zeggwagh NA. Antidiabetic plants improving insulin sensitivity. J Pharm Pharmacol. 2014 Sep;66(9):1197-214. doi: 10.1111/jphp.12243. Epub 2014 Apr 15.
Zhang JG, Liu Q, Liu ZL, Li L, Yi LT. Antihyperglycemic activity of Anoectochilus roxburghii polysaccharose in diabetic mice induced by high-fat diet and streptozotocin. J Ethnopharmacol. 2015 Apr 22;164:180-5. doi: 10.1016/j.jep.2015.01.050. Epub 2015 Feb 7.
Tukappa N K A, Londonkar RL, Nayaka HB, Kumar C B S. Cytotoxicity and hepatoprotective attributes of methanolic extract of Rumex vesicarius L. Biol Res. 2015 Mar 25;48(1):19. doi: 10.1186/s40659-015-0009-8.
Wang JJ, Zhao R, Liang JC, Chen Y. The antidiabetic and hepatoprotective effects of magnolol on diabetic rats induced by high-fat diet and streptozotocin. Yao Xue Xue Bao. 2014 Apr;49(4):476-81.
Pascoe-Gonzalez S, Ramos-Zavala MG, Buenrostro Ahued MA, Hernandez-Gonzalez SO, Cardona-Munoz EG, Garcia-Benavides L, Grover-Paez F. Administration of Herbarium Mixture (Guazuma ulmifolia/Tecoma stans) on Metabolic Profile in Type 2 Diabetes Mellitus Patients: A Randomized, Double-Blind, Placebo-Controlled Trial. J Med Food. 2021 May;24(5):527-532. doi: 10.1089/jmf.2020.0082. Epub 2020 Sep 21.
Other Identifiers
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1111
Identifier Type: -
Identifier Source: org_study_id