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This is a randomized, double-blind, placebo-controlled, add-on clinical trial to evaluate the efficacy and safety of Momordica Charantia extracts taken orally for 3 months by subjects with type 2 diabetes. A total of 40 subjects who meet the inclusion criteria and give written consent will be randomly assigned to (A) Momordica charantia extracts group (600mg/day), or (B) Placebo group (Starch 600mg/day) with 20 subjects for each group. Major enrollment criteria include: (1)Subjects have confirmed type 2 diabetes and fail to reach the treatment goal (fasting glucose 140-270mg/dL and hemoglobin A1c (HbA1c) 7-10%) after stable use of 1-3 oral hypoglycemic drugs for 3 months; (2)Subjects have stable diabetes mellitus (DM) history with fasting glucose 140-270mg/dL and HbA1c 7-10% and refuse to use oral medications. Efficacy outcomes include the changes in fasting glucose, Hb1Ac, and insulin sensitivity, and safety assessments include liver and kidney function, and complains made by subjects after the initiation of the investigational products (IP).
This study aims to investigate the hypoglycemic efficacy of oral Momordica Charantia extracts containing mcIRBP manufactured by Greenyn Biotechnology. The study objectives include:
This is a randomized, double-blind, placebo-controlled, add-on clinical trial to evaluate the efficacy and safety of Momordica Charantia extracts taken orally for 3 months by subjects with type 2 diabetes. A total of 40 subjects who meet the enrollment criteria and give written consent will be randomly assigned to (A) Momordica charantia extracts group (600mg/day), or (B) Placebo group (Starch 600mg/day) with 20 subjects for each group. Subjects will take the IP for 12 weeks and the hypoglycemic medications taken by the subjects before enrollment will remain stable over the study period.
Study procedures for each visit:
Visit 1: Day 0
Visit 2: <7 day from Visit 1
Visit 3: 1 month after Visit 1
Visit 4: 3 months after Visit 1
Statistical Analysis All randomized subjects will be entered for efficacy analysis dataset, and subjects who receives at least one dose of IP will be included for safety analysis. Mean and standard deviation will be used for data presentation, and changes from baseline for all assessments will be plotted against time. Paired t test will be performed for the before and after treatment comparison within group, and 2-independent t test will be used to compare the changes from baseline between the two groups. All statistical analyses will be conducted by using SPSS v.18 (SPSS Inc., Chicago, IL, USA) and p<0.05 is considered to have statistical significance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Momordica charantia | Experimental | Subjects will take the capsule of Greenyn Momordica charantia extracts 600 mg/day orally for three months. |
|
| Placebo control | Placebo Comparator | Subjects will take the capsule of Placebo 600 mg/day orally for three months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Greenyn Momordica charantia extracts | Dietary Supplement | Extracts from Momordica charantia containing Momordica charantia insulin receptor binding protein (mcIRBP) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fasting glucose | Fasting glucose in milligram per deciliter | from baseline at 3 month |
| Glycated hemoglobin | Glycated hemoglobin in percentage | from baseline at 3 month |
| Fasting insulin | Fasting insulin in milliunit per milliliter | from baseline at 3 month |
| Oral Glucose Tolerance Test | Oral Glucose Tolerance Test in milligram per deciliter | from baseline at 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| Total cholesterol | Total cholesterol in milligram per deciliter | from baseline at 3 month |
| L.D.L.cholesterol | L.D.L.cholesterol in milligram per deciliter |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chien-Ning Huang, Ph.D. | Chung Shan Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung Shan Medical University Hospital | Taichung | 40201 | Taiwan |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Placebo control | Dietary Supplement | Starch |
|
| from baseline at 3 month |
| H.D.L.cholesterol | H.D.L.cholesterol in milligram per deciliter | from baseline at 3 month |
| Body mass index(BMI) | BMI in kg/m^2 | from baseline at 3 month |
| Body fat | Body fat in percentage | from baseline at 3 month |
| Waist circumference | Waist circumference in centimeter | from baseline at 3 month |
| Hip circumference | Hip circumference in centimeter | from baseline at 3 month |
| Upper arm circumference | Upper arm circumference in centimeter | from baseline at 3 month |
| Ketone body | Ketone body in positive or negative | from baseline at 3 month |
| total protein | total protein in gram per deciliter | from baseline at 3 month |
| Blood pressure | Blood pressure in millimeter of mercury | from baseline at 3 month |
| Aspartate Aminotransferase (AST) | Aspartate Aminotransferase (AST) in IU per liter | from baseline at 3 month |
| Alanine Aminotransferase (ALT) | Alanine Aminotransferase (ALT) in IU per liter | from baseline at 3 month |
| Creatinine | Creatinine in milligram per deciliter | from baseline at 3 month |
| Blood urea nitrogen (BUN) | BUN in milligram per deciliter | from baseline at 3 month |
| Uric Acid(UA) | UA in milligram per deciliter | from baseline at 3 month |
| Hemoglobin(Hb) | Hb in gram per deciliter | from baseline at 3 month |
| D006946 | Hyperinsulinism |