Metabolic and Therapeutic Effects of American and Korean Red Ginseng in the Treatment of Type 2 Diabetes

Unity Health Toronto

Status and phase: Unknown; Phase 2

Conditions: Diabetes Mellitus Type 2

Treatments: Dietary Supplement: American Ginseng (Panax quinquefolius L.); Dietary Supplement: American Ginseng (Panax quinquefolius L.) and Korean Red Ginseng (steamed Panax C.A. Meyer); Dietary Supplement: Wheat Bran

Study type: Interventional

Funder types: Other

Identifiers

NCT00728403

122380

Details and patient eligibility

About

The study is a 2 phase double blind randomized placebo control trial. The objective is to asses the metabolic and therapeutic effects of American Ginseng (Panax quinquefolius L.) extract and Korean Red Ginseng (steamed Panax C.A. Meyer) extract in the management of type 2 diabetes in a 12 week period. One Hundred and twenty subjects with type 2 diabetes (hyperglycemia key inclusion criteria: HbAlc≥6.5% - ≤ 8.1% ) will participate in the study (36 men and 36 post-menopausal women).

Enrollment: 120 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• presence of type 2 diabetes (at least 1 year) as defined by A1c between ≥6.5% and ≤8.1%, at recruitment,
• treatment with diet or oral hypoglycemic medication be unchanged starting at least 2 months prior to the beginning of the study (at recruitment, week -8)
• between the age of 40 and 75 years
• systolic blood pressure <140 and diastolic blood pressure <90
• clinically euthyroid (measuring T3 and T4)
• normal renal and liver functions
• post-menopausal or non-pregnant women (Post-menopausal includes: those females with more than a year of cessation of menstruation)
• a negative result on a pregnancy test administered at screening
• subjects taking an effective form of birth control (example: condom, abstinence, etc.)
• willing to comply with the study protocol and sign a consent form

Exclusion criteria

• individuals with bleeding disorders
• individuals with allergies to nitroglycerin
• planned surgery, pregnancy or breastfeeding
• taking insulin; clinically significant diabetes complications (retinopathy, nephropathy, or neuropathy); serum triglycerides ≥ 4.5 mmol/L
• increased A1c level of more than 2% from baseline during the study
• history of angina or heart attack
• use of ginseng or any natural health products with glucose modulating and/or anti-platelet activity within 2 months
• BMI > 35 kg/m2 including a weight fluctuation of + 2kg during treatment periods
• smoke cigarettes; alcohol intake > 2 drinks/day
• the presence of any conditions which, in the opinion of the investigator, might jeopardize the health and safety of the subject or study personnel or adversely affect the study results, if the subject participated in the study
• Subjects taking Warfarin or Coumadin, prescription NSAIDs, chronic use of high-dose (>81mg) non-prescription NSAIDs, or selective serotonin reuptake inhibitors and monoamine oxidase inhibitors, or sympathomimetics or medications affecting nitric oxide levels, or any known or suspected sensitivity to any of the ingredients in the test product or placebo cannot participate in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

American Ginseng and American Red Ginseng Capsules

Treatment:

Dietary Supplement: American Ginseng (Panax quinquefolius L.) and Korean Red Ginseng (steamed Panax C.A. Meyer)

2

Experimental group

Description:

American Ginseng Capsules

Treatment:

Dietary Supplement: American Ginseng (Panax quinquefolius L.)

3

Placebo Comparator group

Description:

Placebo Capsules

Treatment:

Dietary Supplement: Wheat Bran