Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-18 @ 6:49 PM
Study NCT ID:
NCT03313856
Status:
COMPLETED
Last Update Posted:
2017-10-18
First Post:
2017-09-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Oral Administration of a Herbarium Mixture (Guazuma Ulmifolia and Tecoma Stans) on Metabolic Profile in Type 2 Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Simple random. It was done with a table of numbers using random selection program Excel 2010.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2011-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-17', 'studyFirstSubmitDate': '2017-09-27', 'studyFirstSubmitQcDate': '2017-10-17', 'lastUpdatePostDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modification in fasting glucose in patients with type 2 diabetes after of administration of combination with Guazuma ulmifolia and Tecoma stans', 'timeFrame': '90 days', 'description': '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.'}, {'measure': 'Modification in HbA1c in patients with type 2 diabetes after of administration of combination with Guazuma ulmifolia and Tecoma stans', 'timeFrame': '90 days', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in lipid profile in patients with type 2 diabetes after of administration of combination with Guazuma ulmifolia and Tecoma stans', 'timeFrame': '90 days', 'description': '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.'}, {'measure': 'Modification in insulin in patients with type 2 diabetes after of administration of combination with Guazuma ulmifolia and Tecoma stans', 'timeFrame': '90 days', 'description': '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.'}, {'measure': 'Hepatic safety of administration of guazuma, tecoma through the determination of hepatic profile', 'timeFrame': '90 days', 'description': '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.'}, {'measure': 'Renal safety of administration of guazuma, tecoma through the determination of serum creatinine', 'timeFrame': '90 days', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '22087686', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25685282', 'type': 'BACKGROUND', 'citation': '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': '15964161', 'type': 'BACKGROUND', 'citation': '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': '9741887', 'type': 'BACKGROUND', 'citation': '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': '12127230', 'type': 'BACKGROUND', 'citation': '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': '1819981', 'type': 'BACKGROUND', 'citation': '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': '18487028', 'type': 'BACKGROUND', 'citation': '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': '15013195', 'type': 'BACKGROUND', 'citation': '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': '9683340', 'type': 'BACKGROUND', 'citation': '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': '24730446', 'type': 'BACKGROUND', 'citation': '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': '25660333', 'type': 'BACKGROUND', 'citation': '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': '25857314', 'type': 'BACKGROUND', 'citation': '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': '24974464', 'type': 'BACKGROUND', 'citation': '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': '32955964', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signing of letter of consent under written information.\n* Men and women with serum glucose of ≥126 and \\<400 mg / dl and / or HbA1c ≥6.5% and \\<10%.\n* Age between 30 and 60 years.\n* BMI between 25 - 39.9 kg / m2.\n* With or without pharmacological treatment with oral hypoglycemic agents or insulin\n* Stable body weight during the last 3 months (± 5%).\n* Women in the follicular phase of the menstrual cycle (days 3 to 8 of the cycle) at the time of the laboratory tests\n* Women who do not expect to be pregnant within the next 3 months.\n\nExclusion Criteria:\n\n* Physical or mental incapacity that makes it impossible to carry out the intervention.\n* Uncontrolled thyroid disease\n* Women with suspicion or confirmation of pregnancy.\n* Women who are breastfeeding.\n* Hepatic disease or elevation to double the upper normal value of TGO and TGP.\n* Diagnosis of renal insufficiency or creatinine\\> 1.5 mg / dL or glomerular filtration rate \\<60 mL / min).\n* Known hypersensitivity to calcined magnesia or Guazuma ulmifolia and / or Tecoma stans.'}, 'identificationModule': {'nctId': 'NCT03313856', 'acronym': 'GUATECO', 'briefTitle': 'Effect of Oral Administration of a Herbarium Mixture (Guazuma Ulmifolia and Tecoma Stans) on Metabolic Profile in Type 2 Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Centro Universitario de Ciencias de la Salud, Mexico'}, 'officialTitle': 'Effect of Oral Administration of a Herbarium Mixture (Guazuma Ulmifolia and Tecoma Stans) on Metabolic Profile in Type 2 Diabetic Patients', 'orgStudyIdInfo': {'id': '1111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The patients were randomly assigned to received placebo (calcinaned magnesia), 1 capsule before each meal for a period of 90 days.', 'interventionNames': ['Drug: Calcinaned magnesia']}, {'type': 'EXPERIMENTAL', 'label': 'Guazuma ulmifolia plus Tecoma stans', 'description': '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.', 'interventionNames': ['Drug: Guazuma Ulmifolia plus Tecoma Stans']}], 'interventions': [{'name': 'Guazuma Ulmifolia plus Tecoma Stans', 'type': 'DRUG', 'otherNames': ['GUATECO'], 'description': 'Guazuma ulmifolia (313.6 mg) -Tecoma stans (86.4 mg) = 400 mg per capsule', 'armGroupLabels': ['Guazuma ulmifolia plus Tecoma stans']}, {'name': 'Calcinaned magnesia', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Calcined magnesia 400 mg per capsule', 'armGroupLabels': ['Placebo']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Universitario de Ciencias de la Salud, Mexico', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Maria Guadalupe Ramos Zavala', 'investigatorAffiliation': 'Centro Universitario de Ciencias de la Salud, Mexico'}}}}