DiabetesEarly Phase 1NCT00781534
A Clinical Trial of Ginseng in Diabetes
A Early Phase 1 study testing Ginseng and ginsenoside RE in people with Diabetes, run by Washington University School of Medicine at 1 site in United States.
Trial summary
a clinical study of Ginseng its potential affect on diabetes Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Ginseng and ginsenoside RE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Sep 2008
- Phase
- Early Phase 1
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ages 18-65
- healthy, non-diabetic
- healthy, impaired glucose tolerance/mild diabetes (no medications required)
Who cannot join
- impaired glucose tolerance (borderline diabetes that requires medications)
- diabetes (requiring medications)
- caffeine sensitivity
- known cardiac, peripheral vascular diseases
- arrhythmias (irregular heart rhythms)
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Clinical Trial of Ginseng for Glucose Intolerance
a clinical study of Ginseng its potential affect on diabetes
Read the detailed description
Comparing three groups (those with \& without normal blood sugar levels) to see if there is any clinically significant change in blood sugar levels in relationship to those taking:
- ginseng
- ginsenoside RE (a type of metabolized ginseng)
- placebo
- Conditions
- Diabetes
- Being tested
- Ginseng, ginsenoside RE, Placebo (sugar pill)
- Keywords
- Health Supplements, Ginseng, Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GinsengDrug
Each of the 3 arms will be compared to determine if there is any clinical difference in blood sugars between the 3 groups
GinsengDrug
ginsenoside REDrug
active metabolite of ginseng
Placebo (sugar pill)Dietary supplement
placebo group
| Study group | Role | What they receive |
|---|---|---|
| 1. Ginseng | Active comparator | Ginseng group Receives: Drug: Ginseng |
| 2. Ginsenosdie RE | Active comparator | Ginsenoside RE (a metabolite of ginseng) group Receives: Drug: Ginseng; Drug: ginsenoside RE |
| 3. Placebo | Placebo comparator | placebo ("sugar" pill) group Receives: Dietary Supplement: Placebo (sugar pill) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2008 (estimated)
- Study startSep 2003
- Primary completionDec 2004
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Kenneth S Polonsky, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781534
- Sponsor's protocol ID
- 03-0824
- Status last verified
- Sep 2019
- First submitted
- 27 Oct 2008
- Last updated
- 9 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Reeds DN, Patterson BW, Okunade A, Holloszy JO, Polonsky KS, Klein S. Ginseng and ginsenoside Re do not improve beta-cell function or insulin sensitivity in overweight and obese subjects with impaired glucose tolerance or diabetes. Diabetes Care. 2011 May;34(5):1071-6. doi: 10.2337/dc10-2299. Epub 2011 Mar 16.
PubMed 21411505
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of Ginseng for Glucose Intolerance
- ClinicalTrials.gov ID
- NCT00781534
- Acronym / sponsor ID
- 03-0824
- Conditions
- Diabetes
- Keywords
- Health Supplements, Ginseng, Diabetes
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Sep 2003
- Primary completion
- Dec 2004 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 29 Oct 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.
a clinical study of Ginseng its potential affect on diabetes
Detailed description
Comparing three groups (those with \& without normal blood sugar levels) to see if there is any clinically significant change in blood sugar levels in relationship to those taking:
- ginseng
- ginsenoside RE (a type of metabolized ginseng)
- placebo
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1. Ginseng | Active comparator | Drug: GinsengGinseng group |
| 2. Ginsenosdie RE | Active comparator | Drug: Ginseng, Drug: ginsenoside REGinsenoside RE (a metabolite of ginseng) group |
| 3. Placebo | Placebo comparator | Dietary Supplement: Placebo (sugar pill)placebo ("sugar" pill) group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ages 18-65
- healthy, non-diabetic
- healthy, impaired glucose tolerance/mild diabetes (no medications required)
Key exclusion criteria (5 listed)
- impaired glucose tolerance (borderline diabetes that requires medications)
- diabetes (requiring medications)
- caffeine sensitivity
- known cardiac, peripheral vascular diseases
- arrhythmias (irregular heart rhythms)
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 |
|---|---|---|
| GinsengEach of the 3 arms will be compared to determine if there is any clinical difference in blood sugars between the 3 groups | Drug | 1. Ginseng |
| Ginseng | Drug | 2. Ginsenosdie RE |
| ginsenoside REactive metabolite of ginseng | Drug | 2. Ginsenosdie RE |
| Placebo (sugar pill)placebo group | Dietary supplement | 3. Placebo |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Derived from this study: PubMed 21411505Reeds DN, Patterson BW, Okunade A, Holloszy JO, Polonsky KS, Klein S. Ginseng and ginsenoside Re do not improve beta-cell function or insulin sensitivity in overweight and obese subjects with impaired glucose tolerance or diabetes. Diabetes Care. 2011 May;34(5):1071-6. doi: 10.2337/dc10-2299. Epub 2011 Mar 16.
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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.
Kenneth S Polonsky, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ginseng and ginsenoside RE in people with Diabetes, run by Washington University School of Medicine at 1 site in United States.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 9 Sep 2019. 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 United States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00781534, which also lists 1 linked publication.
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 9 Sep 2019.