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| Name | Class |
|---|---|
| Chemical Resources | INDUSTRY |
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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | One hundred type-2 diabetes patients with standard oral hypoglycemic drugs (metformin +/- sulfonylurea) will be recruited and followed up without add-on fenugreek extract. |
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| Fenugreek | Experimental | One hundred type-2 diabetes patients with standard oral hypoglycemic drugs (metformin +/- sulfonylurea) will be recruited and followed up with add-on fenugreek extract. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral hypoglycemic agents (pre-specified) [Metformin, Sulfonylurea] | Drug | Patients receiving either of the following oral hypoglycemic agents
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| Measure | Description | Time Frame |
|---|---|---|
| Glycosylated hemoglobin (HbA1c) | HbA1c will be evaluated using Hb variant (HPLC) | Change from baseline HbA1c over 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting blood glucose | METHOD : SPECTROPHOTOMETRY HEXOKINASE | Change from baseline Fasting Blood Glucose over 12 weeks |
| Serum Insulin | by CHEMILUMINESCENCE method |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medicine and Department of Pharmacology, AIIMS | Bhubaneswar | Odisha | 751019 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11868855 | Result | 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. | |
| 24438170 | Result | 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. |
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| Fenugreek Seed extract | Dietary Supplement | 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 |
|
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| Change from baseline Serum Insulin over 12 weeks |
| Serum C-Peptide | by CHEMILUMINESCENCE method | Change from baseline Serum C-Peptide over 12 weeks |
| Renal Function Test | by Spectrophotometry | Change from baseline Renal function test over 12 weeks |
| Liver Function Test | by Spectrophotometry | Change from baseline Liver function test over 12 weeks |
| Hematology (whole blood cell count) | Automated particle cell counter and microscopy | Change from baseline Hematology over 12 weeks |
| Urinary sugar | Semi-quantitative Biochemical test | Change from baseline Urinary over 12 weeks |
| Post-prandial Blood Glucose | METHOD: SPECTROPHOTOMETRY HEXOKINASE | Change from baseline post-prandial Blood Glucose over 12 weeks |
| 21654091 | Result | 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. |
| 17313713 | Result | 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. |
| ID | Term |
|---|---|
| D007004 | Hypoglycemic Agents |
| D008687 | Metformin |
| D013453 | Sulfonylurea Compounds |
| C056164 | fenugreek seed meal |
| ID | Term |
|---|---|
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D014508 | Urea |
| D000577 | Amides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
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