Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Canadian Diabetes Association | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is a combined Phase-I like (safety) and Phase-II like (efficacy) double blind randomized placebo controlled trial. The objective is to investigate whether the combination of AG and Rg3-enriched Korean Red ginseng added to conventional medical treatment are effective and safe in the long-term management of high blood pressure while managing type 2 diabetes. Eighty-five subjects with type 2 diabetes and concomitant high blood pressure (key inclusion criteria: HbA1c ≥ 6.5%- ≤ 8.0%) will be recruited for the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ginseng | Experimental | Combined Rg3-enriched Korean Red Ginseng and American Ginseng capsule |
|
| Wheat Bran | Placebo Comparator | 100 % Natural Wheat Bran capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ginseng | Dietary Supplement | 2.25g of encapsulated ginseng (1.5g American Ginseng and 0.75g Rg3-enriched Korean Red Ginseng)will be administered in 6 identical capsules, 2 capsules with each meal (total 6 capsules per day). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean 24 hour Systolic Ambulatory Blood Pressure at 12 weeks | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean 24 hour Diastolic, daytime and nighttime Ambulatory Blood pressure at 12 Weeks | 12 Weeks | |
| Change in Pulse Pressure | 12 Weeks | |
| Change in Central Augmentation Index and pulse wave analysis |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vladimir Vuksan, PhD | Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34803424 | Derived | Jovanovski E, Smircic-Duvnjak L, Komishon A, Au-Yeung FR, Sievenpiper JL, Zurbau A, Jenkins AL, Sung MK, Josse R, Li D, Vuksan V. Effect of coadministration of enriched Korean Red Ginseng (Panax ginseng) and American ginseng (Panax quinquefolius L) on cardiometabolic outcomes in type-2 diabetes: A randomized controlled trial. J Ginseng Res. 2021 Sep;45(5):546-554. doi: 10.1016/j.jgr.2019.11.005. Epub 2019 Nov 14. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000713447 | Asian ginseng |
| D004043 | Dietary Fiber |
| ID | Term |
|---|---|
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Wheat Bran | Dietary Supplement | 2.25g of encapsulated 100% natural wheat bran will be administered in 6 identical capsules, 2 capsules with each meal (total 6 capsules per day). |
|
| 12 Weeks |
| Change in Pulse Wave Velocity at 12 Weeks | 12 Weeks |
| Change in low-grade body inflammation (hs-CRP) | 12 Weeks |
| Change in HbA1c | 12 Weeks |
| Change in Fasting Insulin | 12 Weeks |
| Change in Fasting Glucose | 12 Weeks |
| Change in Calculated HOMA-Insulin Sensitivity | 12 Weeks |
| Change in RHI at 12 weeks | vs control | 12 weeks |
| Change in lipids at 12 weeks | vs control | 12 weeks |
| Clinical Centre Vuk Vrhovac |
| Zagreb |
| 10000 |
| Croatia |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010829 |
| Physiological Phenomena |
| D019602 | Food and Beverages |