XerostomiaPhase 1/2NCT01647737
Green Tea Lozenges for the Management of Dry Mouth
A Phase 1/2 study testing MighTeaFlow and Xylitol in people with Xerostomia and Sjogren Syndrome, run by Augusta University at 1 site in United States.
Trial summary
The goal of this proposal is to investigate the effectiveness of a Medical College of Georgia patent pending formulation of natural plant extracts on patients with xerostomia. The major component of this formulation is green tea extract with a defined composition of polyphenols. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Xerostomia, Sjogren Syndrome, Dry Mouth
- What is being tested?
- MighTeaFlow and Xylitol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Jun 2013
- Phase
- Phase 1/2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A complaint of dry mouth as assessed by a response of 30mm or greater on a Dry Mouth Visual Analog Scale (VAS)
- Clinical Diagnosis of primary or secondary Sjogren's syndrome.
- Over the age of 18.
- Taking less than three drugs associated with causing xerostomia or salivary gland hypofunction.
- Willing to use natural novel topical dry mouth products.
- Prior minor salivary gland biopsy and serology from Sjogren's Syndrome/Xerostomia work-up.
- Willing to return for all study-associated visits.
- Able to read, understand, and sign the informed consent.
Who cannot join
- Have received radiation to the head and neck region.
- Unable to read and understand the consent form.
- On greater than three drugs associated with xerostomia or salivary gland hypofunction.
- Require dento-alveolar surgery or extensive dental treatment during the course of the study.
- Require hospitalization for any medical problem during the course of the study.
- Unable to take green tea leaf extract and/or pilocarpus jaborandi leaf extract and/or xylitol because of allergy
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- Uncontrolled medical conditions that require changes in medication during the course of the study.
- Regularly consume green tea and/or components of pilocarpus jaborandi.
- Are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
GHSU Center for Oral Medicine
Augusta, Georgia, 30912
About this study
Official title: A Natural Formulation for Patients Diagnosed With Xerostomia
The goal of this proposal is to investigate the effectiveness of a Medical College of Georgia patent pending formulation of natural plant extracts on patients with xerostomia. The major component of this formulation is green tea extract with a defined composition of polyphenols. Epidemiological studies suggest that phytochemicals in green tea possess beneficial effects on autoimmune and inflammatory diseases. Thus far, there is little evidence to indicate any marked and direct immunomodulatory effect of green tea on T or B lymphocytes. However, there is considerable evidence for green tea polyphenols (GTPs), major phytochemicals found in green tea extract, having properties consistent with effects on cells of tissues that would be protective towards local inflammation.
Read the detailed description
Patients with subjective complaints of xerostomia will be given a screening questionnaire to complete. If they meet the criteria on this screening form, the research coordinator will be notified and will meet with the patient either immediately or at a scheduled follow-up appointment. The research coordinator will review the information and then explain the details of the study to the patient and obtain informed consent. Once the patient has signed the informed consent, the research coordinator will collect the demographic, medical history, and contact information from the patient. Any information missing will be noted for follow-up investigation by the research coordinator. If a subject is of child bearing age, they will be asked to complete a urine pregnancy test prior to enrollment.[a] First appointment -Screening, consent. [b]Follow appointments- review, then Patients will do VAS questionnaire, QOL questionnaire, Sialometry will be done measuring unstimulated whole saliva and Stimulated whole saliva for 5 min each.
- Conditions
- Xerostomia, Sjogren Syndrome, Dry Mouth
- Being tested
- MighTeaFlow, Xylitol
- Keywords
- Xerostomia, Sjogren syndrome, dry mouth
- Medical subject headings
- Xerostomia, Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MighTeaFlowDietary supplement
Also called Green Tea Lozenge
4-6 times daily
XylitolDietary supplement
Also called Aspartame
4-6 times daily
| Study group | Role | What they receive |
|---|---|---|
| MighTeaFlow | Active comparator | 4-6 times daily lozenge containing green tea, jaborandi extracts, and 500 mg xylitol for 8 weeks Receives: Dietary Supplement: MighTeaFlow |
| Xylitol | Active comparator | 4-6 times daily lozenge containing jaborandi extract, and 500 mg xylitol for 8 weeks Receives: Dietary Supplement: Xylitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Salivary Flow From Baseline
Change in salivary flow in Xerostomic patients using Green tea lozenges
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 posted24 Jul 2012 (estimated)
- Study startMar 2011
- Primary completionJun 2013
- Study completionJun 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Scott DeRossi, Augusta University
- Investigators
- Scott S De Rossi, DMD, Principal investigator, GHSU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647737
- Sponsor's protocol ID
- GHSU Lozenge Xerostomia Study
- Status last verified
- Mar 2015
- First submitted
- 14 May 2012
- Last updated
- 18 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
De Rossi SS, Thoppay J, Dickinson DP, Looney S, Stuart M, Ogbureke KU, Hsu S. A phase II clinical trial of a natural formulation containing tea catechins for xerostomia. Oral Surg Oral Med Oral Pathol Oral Radiol. 2014 Oct;118(4):447-454.e3. doi: 10.1016/j.oooo.2014.06.015. Epub 2014 Jul 5.
PubMed 25240992
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Natural Formulation for Patients Diagnosed With Xerostomia
- ClinicalTrials.gov ID
- NCT01647737
- Acronym / sponsor ID
- GHSU Lozenge Xerostomia Study
- Conditions
- Xerostomia, Sjogren Syndrome, Dry Mouth
- Keywords
- Xerostomia, Sjogren syndrome, dry mouth
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Mar 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 24 Jul 2012 (estimated)
- Results
- Posted 18 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this proposal is to investigate the effectiveness of a Medical College of Georgia patent pending formulation of natural plant extracts on patients with xerostomia. The major component of this formulation is green tea extract with a defined composition of polyphenols. Epidemiological studies suggest that phytochemicals in green tea possess beneficial effects on autoimmune and inflammatory diseases. Thus far, there is little evidence to indicate any marked and direct immunomodulatory effect of green tea on T or B lymphocytes. However, there is considerable evidence for green tea polyphenols (GTPs), major phytochemicals found in green tea extract, having properties consistent with effects on cells of tissues that would be protective towards local inflammation.
Detailed description
Patients with subjective complaints of xerostomia will be given a screening questionnaire to complete. If they meet the criteria on this screening form, the research coordinator will be notified and will meet with the patient either immediately or at a scheduled follow-up appointment. The research coordinator will review the information and then explain the details of the study to the patient and obtain informed consent. Once the patient has signed the informed consent, the research coordinator will collect the demographic, medical history, and contact information from the patient. Any information missing will be noted for follow-up investigation by the research coordinator. If a subject is of child bearing age, they will be asked to complete a urine pregnancy test prior to enrollment.[a] First appointment -Screening, consent. [b]Follow appointments- review, then Patients will do VAS questionnaire, QOL questionnaire, Sialometry will be done measuring unstimulated whole saliva and Stimulated whole saliva for 5 min each.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MighTeaFlow | Active comparator | Dietary Supplement: MighTeaFlow4-6 times daily lozenge containing green tea, jaborandi extracts, and 500 mg xylitol for 8 weeks |
| Xylitol | Active comparator | Dietary Supplement: Xylitol4-6 times daily lozenge containing jaborandi extract, and 500 mg xylitol for 8 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- A complaint of dry mouth as assessed by a response of 30mm or greater on a Dry Mouth Visual Analog Scale (VAS)
- Clinical Diagnosis of primary or secondary Sjogren's syndrome.
- Over the age of 18.
- Taking less than three drugs associated with causing xerostomia or salivary gland hypofunction.
- Willing to use natural novel topical dry mouth products.
Key exclusion criteria (9 listed)
- Have received radiation to the head and neck region.
- Unable to read and understand the consent form.
- On greater than three drugs associated with xerostomia or salivary gland hypofunction.
- Require dento-alveolar surgery or extensive dental treatment during the course of the study.
- Require hospitalization for any medical problem during the course of 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 |
|---|---|---|
| MighTeaFlowAlso: Green Tea Lozenge4-6 times daily | Dietary supplement | MighTeaFlow |
| XylitolAlso: Aspartame4-6 times daily | Dietary supplement | Xylitol |
Primary outcome
Change in Salivary Flow From Baseline
Time frame: 8 weeks
Change in salivary flow in Xerostomic patients using Green tea lozenges
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25240992De Rossi SS, Thoppay J, Dickinson DP, Looney S, Stuart M, Ogbureke KU, Hsu S. A phase II clinical trial of a natural formulation containing tea catechins for xerostomia. Oral Surg Oral Med Oral Pathol Oral Radiol. 2014 Oct;118(4):447-454.e3. doi: 10.1016/j.oooo.2014.06.015. Epub 2014 Jul 5.
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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.
Scott S De Rossi, DMD principal investigator
GHSU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MighTeaFlow and Xylitol in people with Xerostomia and Sjogren Syndrome, run by Augusta University 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 8 inclusion and 9 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 18 Mar 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 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 18 Mar 2015). 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?
Change in Salivary Flow From Baseline (time frame: 8 weeks). 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 NCT01647737, 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 18 Mar 2015.