Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-02-23 @ 11:35 AM
Study NCT ID:
NCT02693392
Status:
COMPLETED
Last Update Posted:
2018-08-17
First Post:
2016-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of Fenugreek Seed Extract, a Nutraceutical in Patients With Type- 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007004', 'term': 'Hypoglycemic Agents'}, {'id': 'D008687', 'term': 'Metformin'}, {'id': 'D013453', 'term': 'Sulfonylurea Compounds'}, {'id': 'C056164', 'term': 'fenugreek seed meal'}], 'ancestors': [{'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-15', 'studyFirstSubmitDate': '2016-02-19', 'studyFirstSubmitQcDate': '2016-02-25', 'lastUpdatePostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycosylated hemoglobin (HbA1c)', 'timeFrame': 'Change from baseline HbA1c over 12 weeks', 'description': 'HbA1c will be evaluated using Hb variant (HPLC)'}], 'secondaryOutcomes': [{'measure': 'Fasting blood glucose', 'timeFrame': 'Change from baseline Fasting Blood Glucose over 12 weeks', 'description': 'METHOD : SPECTROPHOTOMETRY HEXOKINASE'}, {'measure': 'Serum Insulin', 'timeFrame': 'Change from baseline Serum Insulin over 12 weeks', 'description': 'by CHEMILUMINESCENCE method'}, {'measure': 'Serum C-Peptide', 'timeFrame': 'Change from baseline Serum C-Peptide over 12 weeks', 'description': 'by CHEMILUMINESCENCE method'}, {'measure': 'Renal Function Test', 'timeFrame': 'Change from baseline Renal function test over 12 weeks', 'description': 'by Spectrophotometry'}, {'measure': 'Liver Function Test', 'timeFrame': 'Change from baseline Liver function test over 12 weeks', 'description': 'by Spectrophotometry'}, {'measure': 'Hematology (whole blood cell count)', 'timeFrame': 'Change from baseline Hematology over 12 weeks', 'description': 'Automated particle cell counter and microscopy'}, {'measure': 'Urinary sugar', 'timeFrame': 'Change from baseline Urinary over 12 weeks', 'description': 'Semi-quantitative Biochemical test'}, {'measure': 'Post-prandial Blood Glucose', 'timeFrame': 'Change from baseline post-prandial Blood Glucose over 12 weeks', 'description': 'METHOD: SPECTROPHOTOMETRY HEXOKINASE'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fenugreek seed extract', 'HbA1c', 'Blood glucose'], 'conditions': ['Type-2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '11868855', 'type': 'RESULT', 'citation': 'Gupta A, Gupta R, Lal B. Effect of Trigonella foenum-graecum (fenugreek) seeds on glycaemic control and insulin resistance in type 2 diabetes mellitus: a double blind placebo controlled study. J Assoc Physicians India. 2001 Nov;49:1057-61.'}, {'pmid': '24438170', 'type': 'RESULT', 'citation': 'Neelakantan N, Narayanan M, de Souza RJ, van Dam RM. Effect of fenugreek (Trigonella foenum-graecum L.) intake on glycemia: a meta-analysis of clinical trials. Nutr J. 2014 Jan 18;13:7. doi: 10.1186/1475-2891-13-7.'}, {'pmid': '21654091', 'type': 'RESULT', 'citation': 'Baquer NZ, Kumar P, Taha A, Kale RK, Cowsik SM, McLean P. Metabolic and molecular action of Trigonella foenum-graecum (fenugreek) and trace metals in experimental diabetic tissues. J Biosci. 2011 Jun;36(2):383-96. doi: 10.1007/s12038-011-9042-0.'}, {'pmid': '17313713', 'type': 'RESULT', 'citation': 'Hannan JM, Ali L, Rokeya B, Khaleque J, Akhter M, Flatt PR, Abdel-Wahab YH. Soluble dietary fibre fraction of Trigonella foenum-graecum (fenugreek) seed improves glucose homeostasis in animal models of type 1 and type 2 diabetes by delaying carbohydrate digestion and absorption, and enhancing insulin action. Br J Nutr. 2007 Mar;97(3):514-21. doi: 10.1017/S0007114507657869.'}]}, 'descriptionModule': {'briefSummary': 'In the proposed study, hydroalcoholic Fenugreek seed extract will used add-on to the existing therapy in patients with type-2 diabetes. The efficacy and safety of the extract will be evaluated using standard methodology.', 'detailedDescription': 'Trigonella foenum-graecum, commonly known as Fenugreek, is a plant that has been extensively used as a source of antidiabetic compounds, from its seeds, leaves and extracts in different systems of medicine in asia. Fenugreek is traditionally used in India, especially in the Ayurvedic and Unani systems. Preliminary animal and human studies suggest possible hypoglycemic and anti-hyperlipidemic properties of fenugreek seed powder taken orally. In a randomized placebo controlled study conducted by Gupta et al showed that two month treatment with the hydro-alcoholic extract of fenugreek seeds improved glycemic control in 12 non-insulin dependent diabetes mellitus patients. In addition, there was improvement in insulin sensitivity and plasma lipid profile. Fenugreek extract was also well tolerated in diabetic patients.\n\nIn the proposed study, hydroalcoholic Fenugreek seed extract will used add-on to the existing therapy in patients with type-2 diabetes. The efficacy and safety of the extract will be evaluated using standard methodology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suffering from Type-2 Diabetes of less than 10 years duration\n* Patients with HbA1c \\>7.0%\n* Patients with fasting plasma glucose not exceeding 180 mg/dL\n* Patients with Negative Urine sugar\n* Patients who are on oral hypoglycaemic agents containing either Metformin or Sulfonylurea or both\n* There should not be any change their in anti-diabetic treatment for at least one month\n\nExclusion Criteria:\n\n* Patients with diabetes other than type-2 diabetes mellitus\n* Patients with evidence of renal disease (S. Creatinine \\> 1.5mg/dL)\n* Patients with evidence of liver disease (AST/ALT \\>3 times of normal\n* Pregnant and lactating mothers and women intending pregnancy\n* Patients who participated in any other clinical trial within the last 30 days\n* Patients with history of any hemoglobinopathy\n* History of intolerance or hypersensitivity to Fenugreek'}, 'identificationModule': {'nctId': 'NCT02693392', 'briefTitle': 'Clinical Evaluation of Fenugreek Seed Extract, a Nutraceutical in Patients With Type- 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'All India Institute of Medical Sciences, Bhubaneswar'}, 'officialTitle': 'Clinical Evaluation of Fenugreek Seed Extract, a Nutraceutical in Patients With Type- 2 Diabetes: An Add-On Study', 'orgStudyIdInfo': {'id': 'T/EM-F/Pharma/14/05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'One hundred type-2 diabetes patients with standard oral hypoglycemic drugs (metformin +/- sulfonylurea) will be recruited and followed up without add-on fenugreek extract.', 'interventionNames': ['Drug: Oral hypoglycemic agents (pre-specified) [Metformin, Sulfonylurea]']}, {'type': 'EXPERIMENTAL', 'label': 'Fenugreek', 'description': 'One hundred type-2 diabetes patients with standard oral hypoglycemic drugs (metformin +/- sulfonylurea) will be recruited and followed up with add-on fenugreek extract.', 'interventionNames': ['Drug: Oral hypoglycemic agents (pre-specified) [Metformin, Sulfonylurea]', 'Dietary Supplement: Fenugreek Seed extract']}], 'interventions': [{'name': 'Oral hypoglycemic agents (pre-specified) [Metformin, Sulfonylurea]', 'type': 'DRUG', 'otherNames': ['Metformin, Sulfonylurea'], 'description': 'Patients receiving either of the following oral hypoglycemic agents\n\n1. Sulfonylurea based oral hypoglycemic agents\n2. Metformin based oral hypoglycemic agents\n3. Metformin plus Sulfonylurea based oral hypoglycemic agents', 'armGroupLabels': ['Control', 'Fenugreek']}, {'name': 'Fenugreek Seed extract', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Capsule Fenfuro 500 mg'], 'description': 'Patients recruited in the study arm will receive Capsule Fenfuro 500 milligram twice daily for 12 weeks as add-on intervention to the pre-specified oral hypoglycemic agents therapy', 'armGroupLabels': ['Fenugreek']}]}, 'contactsLocationsModule': {'locations': [{'zip': '751019', 'city': 'Bhubaneswar', 'state': 'Odisha', 'country': 'India', 'facility': 'Department of Medicine and Department of Pharmacology, AIIMS', 'geoPoint': {'lat': 20.27241, 'lon': 85.83385}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'All India Institute of Medical Sciences, Bhubaneswar', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chemical Resources', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor & Head', 'investigatorFullName': 'Dr Debasish Hota', 'investigatorAffiliation': 'All India Institute of Medical Sciences, Bhubaneswar'}}}}