XerostomiaPhase 4NCT00911768
Effect of Korean Red Ginseng (KRG) on Dry Mouth
A Phase 4 study testing Korean Red Ginseng Powder Capsule and Corn-starch powder with ginseng flavor in people with Xerostomia, run by The Korean Society of Ginseng at 1 site in South Korea.
Trial summary
The purpose of this study is to determine the effect of KRG (Korean Red Ginseng) on Dry Mouth (Xerostomia). Read more about this study
- Who is it for?
- Ages 19 to 76 years
- Conditions the study is for
- Xerostomia
- What is being tested?
- Korean Red Ginseng Powder Capsule and Corn-starch powder with ginseng flavor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2007to Dec 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dry mouth patients
Who cannot join
- Sjögren syndrome
- Irradiation related xerostomia
- Severe psychiatric diseases
- pregnancy or breast feeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PMS Clinical Study of Korean Red Ginseng Powder on Dry Mouth and Salivary Flow Rates in Xerostomatic Populations
The purpose of this study is to determine the effect of KRG (Korean Red Ginseng) on Dry Mouth (Xerostomia).
Read the detailed description
Korean Red Ginseng
- Worldwide use
- A main herb of old oriental prescriptions for dry mouth
- Need for correct information by RCT
- Conditions
- Xerostomia
- Being tested
- Korean Red Ginseng Powder Capsule, Corn-starch powder with ginseng flavor
- Keywords
- Xerostomia, Panax ginseng(Korean Red Ginseng), Visual Analogue Scale, Salivary Flow Rates
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Korean Red Ginseng Powder CapsuleDietary supplement
Also called Brand Name: Korean Red Ginseng Powder Capsule
Generic name: Korean Red Ginseng Powder Capsule Original herb name: Panax ginseng Form and contents: Capsule with powder of steamed root of 6-year Panax ginseng Dosage and frequency: 6 g per day (twice a day), Oral administration Administration duration: 56 days in the study
Corn-starch powder with ginseng flavorDietary supplement
Also called Corn-starch powder capsule with Korean Red Ginseng flavor
There is no specific name because this intervention is placebo. This placebo has the same form, color and flavor as Korean Red Ginseng Powder Capsule.
The dosage form, dosage, frequency and duration is also same as experimental intervention (Korean Red Ginseng Powder Capsule).
Main contents: corn-starch with Panax ginseng flavor
| Study group | Role | What they receive |
|---|---|---|
| Korean Red Ginseng group | Experimental | The brand name of experimental drug is 'Capsule of Korean Red Ginseng Powder'. It consists of the powder of steamed root of Panax ginseng made by Korean Ginseng Corp. Receives: Dietary Supplement: Korean Red Ginseng Powder Capsule |
| Corn-starch powder with ginseng flavor | Placebo comparator | The placebo of this study is corn-starch powder with Korean Red Ginseng flavor. It has the same shape, color and flavor like experimental drug. Receives: Dietary Supplement: Corn-starch powder with ginseng flavor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale of Subjective Dry Mouth
Visual Analogue Scale of Subjective Dry Mouth is 10 cm, where 0 cm indicates no dry mouth and 10 cm the severe dry mouth.
Measured: 8 weeks
Secondary outcomes (2)
Stimulated Salivary Flow Rates
Stimulated salivary flow rates were compared between 0 and 8 weeks in both groups.
Measured: 8 weeks
Unstimulated Salivary Flow Rates
Unstimulated salivary flow rates were compared between 0 and 8 weeks in both groups.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2009 (estimated)
- Study startSep 2007
- Primary completionMay 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for XerostomiaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Korean Society of Ginseng
- Sponsor type
- University, hospital or other
- Investigators
- Jae-Woo Park, K.M.D., Ph.D, Principal investigator, Kyung Hee East-West Neo Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00911768
- Sponsor's protocol ID
- KHNMC-OH-IRB 2007-007
- Status last verified
- Aug 2009
- First submitted
- 3 Mar 2009
- Last updated
- 6 Aug 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PMS Clinical Study of Korean Red Ginseng Powder on Dry Mouth and Salivary Flow Rates in Xerostomatic Populations
- ClinicalTrials.gov ID
- NCT00911768
- Acronym / sponsor ID
- KHNMC-OH-IRB 2007-007
- Conditions
- Xerostomia
- Keywords
- Xerostomia, Panax ginseng(Korean Red Ginseng), Visual Analogue Scale, Salivary Flow Rates
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The Korean Society of GinsengUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- May 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 2 Jun 2009 (estimated)
- Results
- Posted 2 Jun 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effect of KRG (Korean Red Ginseng) on Dry Mouth (Xerostomia).
Detailed description
Korean Red Ginseng
- Worldwide use
- A main herb of old oriental prescriptions for dry mouth
- Need for correct information by RCT
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Korean Red Ginseng group | Experimental | Dietary Supplement: Korean Red Ginseng Powder CapsuleThe brand name of experimental drug is 'Capsule of Korean Red Ginseng Powder'. It consists of the powder of steamed root of Panax ginseng made by Korean Ginseng Corp. |
| Corn-starch powder with ginseng flavor | Placebo comparator | Dietary Supplement: Corn-starch powder with ginseng flavorThe placebo of this study is corn-starch powder with Korean Red Ginseng flavor. It has the same shape, color and flavor like experimental drug. |
Who may qualify
- Ages
- 19 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Dry mouth patients
Key exclusion criteria (4 listed)
- Sjögren syndrome
- Irradiation related xerostomia
- Severe psychiatric diseases
- pregnancy or breast feeding women
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 |
|---|---|---|
| Korean Red Ginseng Powder CapsuleAlso: Brand Name: Korean Red Ginseng Powder CapsuleGeneric name: Korean Red Ginseng Powder Capsule Original herb name: Panax ginseng Form and contents: Capsule with powder of steamed root of 6-year Panax ginseng Dosage and frequency: 6 g per day (twice a day), Oral administration Administration duration: 56 days in the study | Dietary supplement | Korean Red Ginseng group |
| Corn-starch powder with ginseng flavorAlso: Corn-starch powder capsule with Korean Red Ginseng flavorThere is no specific name because this intervention is placebo. This placebo has the same form, color and flavor as Korean Red Ginseng Powder Capsule. The dosage form, dosage, frequency and duration is also same as experimental intervention (Korean Red Ginseng Powder Capsule). Main contents: corn-starch with Panax ginseng flavor | Dietary supplement | Corn-starch powder with ginseng flavor |
Primary outcome
Visual Analogue Scale of Subjective Dry Mouth
Time frame: 8 weeks
Visual Analogue Scale of Subjective Dry Mouth is 10 cm, where 0 cm indicates no dry mouth and 10 cm the severe dry mouth.
2 secondary outcomes
Stimulated Salivary Flow Rates
Time frame: 8 weeks
Unstimulated Salivary Flow Rates
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jae-Woo Park, K.M.D., Ph.D principal investigator
Kyung Hee East-West Neo Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Korean Red Ginseng Powder Capsule and Corn-starch powder with ginseng flavor in people with Xerostomia, run by The Korean Society of Ginseng at 1 site in South Korea.
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 1 inclusion and 4 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 6 Aug 2009. 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 South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Visual Analogue Scale of Subjective Dry Mouth (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2009.