| Trial ID: | L2643 |
| Source ID: | NCT02693392
|
| Associated Drug: |
Oral Hypoglycemic Agents (Pre-Specified) [Metformin, Sulfonylurea]
|
| Title: |
Clinical Evaluation of Fenugreek Seed Extract, a Nutraceutical in Patients With Type- 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type-2 Diabetes Mellitus
|
| Interventions: |
DRUG: Oral hypoglycemic agents (pre-specified) [Metformin, Sulfonylurea]|DIETARY_SUPPLEMENT: Fenugreek Seed extract
|
| Outcome Measures: |
Primary: Glycosylated hemoglobin (HbA1c), HbA1c will be evaluated using Hb variant (HPLC), Change from baseline HbA1c over 12 weeks | Secondary: Fasting blood glucose, METHOD : SPECTROPHOTOMETRY HEXOKINASE, Change from baseline Fasting Blood Glucose over 12 weeks|Serum Insulin, by CHEMILUMINESCENCE method, 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
|
| Sponsor/Collaborators: |
Sponsor: All India Institute of Medical Sciences, Bhubaneswar | Collaborators: Chemical Resources
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
200
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
|
| Start Date: |
2016-01-17
|
| Completion Date: |
2018-08-16
|
| Results First Posted: |
|
| Last Update Posted: |
2018-08-17
|
| Locations: |
Department of Medicine and Department of Pharmacology, AIIMS, Bhubaneswar, Odisha, 751019, India
|
| URL: |
https://clinicaltrials.gov/show/NCT02693392
|
