To assess the effect of fenugreek seed extract in diabetes patients

Phase 2

Completed

• Conditions: Health Condition 1: null- Type 2 diabetes mellitusHealth Condition 2: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2018/04/013230
• Lead Sponsor: Indus Biotech Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2002-12-10
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 78

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in fasting plasma glucose from baselineTimepoint: Baseline and day 90 (end of treatment)

Secondary Outcome Measures

Name	Time	Method
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)