NCT01578837

Combined Rg3-enriched Korean Red Ginseng and American Ginseng in the Management of Hypertension in Type 2 Diabetes

Efficacy and Safety of Combined Rg3-enriched Korean Red Ginseng (Panax Ginseng C.A. Meyer) and American Ginseng (Panax Quinquefolius) as Poly-therapy in the Management of Concomitant Hypertension in Type 2 Diabetes

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Diabetes Mellitus Type 2
• Hypertension

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ginseng	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).
DIETARY_SUPPLEMENT	Wheat Bran	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).

Timeline

• Start date: 2014-04-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2012-04-17
• Last updated: 2018-11-21

Locations

2 sites across 2 countries: Canada, Croatia