Effect of Oral Administration of a Herbarium Mixture (Guazuma Ulmifolia and Tecoma Stans) on Metabolic Profile in Type 2 Diabetic Patients

NCT03313856 | Completed Phase 2

• 1 other identifier: 1111
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  90 days

Secondary Outcomes (4)

• Change in lipid profile in patients with type 2 diabetes after of administration of combination with Guazuma ulmifolia and Tecoma stans

  90 days

• Modification in insulin in patients with type 2 diabetes after of administration of combination with Guazuma ulmifolia and Tecoma stans

  90 days

• Hepatic safety of administration of guazuma, tecoma through the determination of hepatic profile

  90 days

• Renal safety of administration of guazuma, tecoma through the determination of serum creatinine

  90 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

The patients were randomly assigned to received placebo (calcinaned magnesia), 1 capsule before each meal for a period of 90 days.

Drug: Calcinaned magnesia

Guazuma ulmifolia plus Tecoma stans

EXPERIMENTAL

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

Interventions

Guazuma Ulmifolia plus Tecoma Stans DRUG

Guazuma ulmifolia (313.6 mg) -Tecoma stans (86.4 mg) = 400 mg per capsule

Also known as: GUATECO

Guazuma ulmifolia plus Tecoma stans

Calcinaned magnesia DRUG

Calcined magnesia 400 mg per capsule

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro Universitario de Ciencias de la Salud, Mexico: lead

Related Publications (14)

• 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.

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• 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.

  PMID: 25685282 BACKGROUND

• 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.

  PMID: 15964161 BACKGROUND

• 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.

  PMID: 9741887 BACKGROUND

• 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.

  PMID: 12127230 BACKGROUND

• 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.

  PMID: 1819981 BACKGROUND

• 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.

  PMID: 18487028 BACKGROUND

• 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.

  PMID: 15013195 BACKGROUND

• 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.

  PMID: 9683340 BACKGROUND

• 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.

  PMID: 24730446 BACKGROUND

• 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.

  PMID: 25660333 BACKGROUND

• 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.

  PMID: 25857314 BACKGROUND

• 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.

  PMID: 24974464 BACKGROUND

• 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.

  PMID: 32955964 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Simple random. It was done with a table of numbers using random selection program Excel 2010.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Two study groups were formed that were randomly assigned with the closed envelope technique to the corresponding group. Group Placebo vs. Guazuma ulmifolia plusTecoma stans

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: October 18, 2017
• Study Start: January 10, 2010
• Primary Completion: December 31, 2010
• Study Completion: May 31, 2011
• Last Updated: October 18, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share