Diabetes Mellitus Type 2Phase 2NCT00728403

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

A Phase 2 study testing American Ginseng (Panax quinquefolius L.) and Korean Red Ginseng (steamed Panax C.A. Meyer), American Ginseng (Panax quinquefolius L.) and Wheat Bran in people with Diabetes Mellitus Type 2, run by Unity Health Toronto at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 40 to 75 years
Conditions the study is for: Diabetes Mellitus Type 2
What is being tested?: American Ginseng (Panax quinquefolius L.) and Korean Red Ginseng (steamed Panax C.A. Meyer), American Ginseng (Panax quinquefolius L.) and Wheat Bran
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 1 siteCanada
Study dates: Sep 2008to Aug 2015
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 10Show fewer

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

Who cannot join

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

Show all 11Show fewer

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 locations and contacts

1 site in 1 country.

Canada1 site

Clinical Nutrition and Risk Factor Modification Centre
Toronto, Ontario, M5C 1N8

Other trials in Canada

About this study

Official title: Long Term Metabolic and Therapeutic Effects of Combined Treatment of American Ginseng (Panax Quinquefolius L.) Extract and Korean Red Ginseng (Steamed Panax C.A. Meyer) Extract in the Treatment of Type 2 Diabetes

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).

Conditions: Diabetes Mellitus Type 2
Being tested: American Ginseng (Panax quinquefolius L.) and Korean Red Ginseng (steamed Panax C.A. Meyer), American Ginseng (Panax quinquefolius L.), Wheat Bran
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

American Ginseng (Panax quinquefolius L.) and Korean Red Ginseng (steamed Panax C.A. Meyer)Dietary supplement
1.5 grams American Ginseng and 1.5 grams Korean Red Ginseng are to be taken in capsulated form. Two capsules are taken with every meal, for a total of 6 capsules per day for 12 weeks
American Ginseng (Panax quinquefolius L.)Dietary supplement
3 grams of American Ginseng is to be taken in capsulated form. Two capsules are taken with every meal, for a total of 6 capsules per day for 12 weeks
Wheat BranDietary supplement
3 grams of Wheat Bran is to be taken in capsulated form. Two capsules are taken with every meal, for a total of 6 capsules per day for 12 weeks

Study groups in NCT00728403
Study group	Role	What they receive
1	Experimental	American Ginseng and American Red Ginseng Capsules Receives: Dietary Supplement: American Ginseng (Panax quinquefolius L.) and Korean Red Ginseng (steamed Panax C.A. Meyer)
2	Experimental	American Ginseng Capsules Receives: Dietary Supplement: American Ginseng (Panax quinquefolius L.)
3	Placebo comparator	Placebo Capsules Receives: Dietary Supplement: Wheat Bran

What is being measured

The primary outcome is the main question the study is designed to answer.

HbA1c levels and insulin sensitivity index using 3 different indices: ISI, HOMA, QUICKI
Measured: Weeks -4, 0, 6, 12

Secondary outcomes (1)

Cholesterol, triglycerides, fasting & post-prandial blood glucose and insulin, C-reactive protein, lipid peroxidation, blood pressure, endothelial function, body fat composition
Measured: Weeks -4, 0, 6, 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2008Aug 2015

First posted5 Aug 2008 (estimated)
Study startSep 2008
Primary completionAug 2015 (estimated)
Study completionAug 2015 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
More trials run by Unity Health TorontoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00728403
Sponsor's protocol ID: 122380
Status last verified: Jul 2015
First submitted: 1 Aug 2008
Last updated: 31 Jul 2015
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long Term Metabolic and Therapeutic Effects of Combined Treatment of American Ginseng (Panax Quinquefolius L.) Extract and Korean Red Ginseng (Steamed Panax C.A. Meyer) Extract in the Treatment of Type 2 Diabetes
ClinicalTrials.gov ID: NCT00728403
Acronym / sponsor ID: 122380
Conditions: Diabetes Mellitus Type 2
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 120 participants (estimated)
Lead sponsor: Unity Health TorontoUniversity, hospital or other
Collaborators: Canadian Diabetes Association
Study start: Sep 2008
Primary completion: Aug 2015 (estimated)
Study completion: Aug 2015 (estimated)
First posted: 5 Aug 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Dietary Supplement: American Ginseng (Panax quinquefolius L.) and Korean Red Ginseng (steamed Panax C.A. Meyer)American Ginseng and American Red Ginseng Capsules
2	Experimental	Dietary Supplement: American Ginseng (Panax quinquefolius L.)American Ginseng Capsules
3	Placebo comparator	Dietary Supplement: Wheat BranPlacebo Capsules

Who may qualify

Ages: 40 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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)

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
American Ginseng (Panax quinquefolius L.) and Korean Red Ginseng (steamed Panax C.A. Meyer)1.5 grams American Ginseng and 1.5 grams Korean Red Ginseng are to be taken in capsulated form. Two capsules are taken with every meal, for a total of 6 capsules per day for 12 weeks	Dietary supplement	1
American Ginseng (Panax quinquefolius L.)3 grams of American Ginseng is to be taken in capsulated form. Two capsules are taken with every meal, for a total of 6 capsules per day for 12 weeks	Dietary supplement	2
Wheat Bran3 grams of Wheat Bran is to be taken in capsulated form. Two capsules are taken with every meal, for a total of 6 capsules per day for 12 weeks	Dietary supplement	3

Primary outcome

HbA1c levels and insulin sensitivity index using 3 different indices: ISI, HOMA, QUICKI
Time frame: Weeks -4, 0, 6, 12

1 secondary outcome

Cholesterol, triglycerides, fasting & post-prandial blood glucose and insulin, C-reactive protein, lipid peroxidation, blood pressure, endothelial function, body fat composition
Time frame: Weeks -4, 0, 6, 12

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2015.

Related trials for Diabetes Mellitus Type 2

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Vladimir Vuksan, PhD principal investigator

Clinical Nutritian and Risk Factor Modification Centre

Alexandra Jenkins, PhD principal investigator

Clinical Nutrition and Risk Factor Modificatrion Centre

Lawerence Leiter, MD principal investigator

St. Michaels Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c levels and insulin sensitivity index using 3 different indices: ISI, HOMA, QUICKI (time frame: Weeks -4, 0, 6, 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00728403.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2015.