Health Condition 1: null- Type 2 diabetes mellitus Health Condition 2: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: IDM1: Hard gelatin capsule containing standardised fenugreek seed extract,
700 mg, three times a day for 90 days
Control Intervention1: Placebo: Hard gelatin capsule containing microcry
Sponsors
Indus Biotech Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Signed informed consent form 2. Type II (non insulin dependent) diabetic patients 3. Fasting plasma glucose between 140 mg/dl and 250 mg/dl (both inclusive) 4. Fasting plasma glucose between 140 mg/dl and 250 mg/dl (both inclusive) that does not vary more than 30 mg/dl during fifteen days run in period 5. HbA1c 7.0 to 12% both inclusive 6. Body mass index 22 to 35 both inclusive 7. Stabilised at same dose of medication (sulphonylurea) for a minimum period of six weeks 8. No history of nephropathy/ketourea 9. No history of HIV 10. Pregnancy test negative 11. No participation in any other trial during past 30 days 12. No history of allergy to the ingredients or plant products or derivatives
Exclusion criteria
Exclusion criteria: 1. Patients above 71 years 2. Patients treated with a drug within last 30 days that has not received regulatory approval at the time of study entry 3. Participation in clinical study during past 30 days 4. Fasting plasma glucose more than or equivalent to 251 mg/dl 5. LFT (ALT/AST) > 2.5 times the upper limit of normal values 6. Requiring a dose of insulin or surgery or other indication 7. History of HIV 8. Creatinine more than or equal to 1.5 mg/dl 9. Pregnant or intend to become pregnant during the study or not actively practicing birth control measures or breast feeding 10. Retinopathy/& nephropathy with persistent macro-albuminuria 11. Patients classified as class III, or class IV heart diseases 12. Abnormal laboratory values revealed on the analysis on baseline visit 13. Patients with clinical signs and symptoms of drug or alcohol abuse 14. Patients undergoing therapy for a malignancy other than basal cell or squamous cell skin cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in fasting plasma glucose from baselineTimepoint: Baseline and day 90 (end of treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in glycated hemoglobin levels from baselineTimepoint: Baseline and day 90 (end of treatment);Change in post prandial glucose from baselineTimepoint: Baseline and day 90 (end of treatment) | — |
Countries
India
Contacts
Public ContactDr Prasad Thakurdesai
Indus Biotech Private Limited
Outcome results
None listed