XerostomiaNCT01579877
Treatment of Xerostomia by Herbal Preparation
A study testing Herbal extract granule in people with Xerostomia, run by Korea Health Industry Development Institute at 1 site in South Korea.
Trial summary
The aims of this study are to investigate the effect of famous herbal formula extract on xerostomia, and to determine whether this formula affect various xerostomia-related questionnaires, salivary flow rate, residual saliva and salivary tests. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Xerostomia
- What is being tested?
- Herbal extract granule
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2012to Nov 2013
- Phase
- Interventional
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 60 - 80
- The visual analog scale for xerostomia must represent more than 4 points during 2wks prior to enrollment
- One who has less than 0.3 ml/min of unstimulated salivary flow rate
- One who has complained of xerostomia for at least 3months
- One who is able to read, write, hear, see something
- One who agree on not taking other therapies during experimental period
- One who agree on consent form
Who cannot join
- One who is taking the treatment for autoimmune disease such as sjogren's disease, rheumatic disease, systemic lupus erythematosus etc
- One who has the history of taking radiotherapy on head and neck or history of organ transplantation
- One who has severe mental illness such as depression
- One who takes oriental medicine or health functional food within 2 wks before enrollment
- One who takes the remedies on the purpose of relieving xerostomia such as pilocarpine, cevimeline, gargle solution, frequent gum use, intra oral devices and toothpaste etc.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kyung Hee University Oriental Medicine Hospital
Seoul, Seoul, 130-872
Jinsung Kim, doctorate, +82-2-958-8895, oridoc@khu.ac.kr
Jae-Woo Park, doctorate, +82-2-440-6219, pjw2907@hanmail.net
About this study
Official title: Efficacy of Yukmijihwang-tang on Xerostomia in the Elderly: A Randomized,Double-blind, Placebo-controlled, Two-center Trial
The aims of this study are to investigate the effect of famous herbal formula extract on xerostomia, and to determine whether this formula affect various xerostomia-related questionnaires, salivary flow rate, residual saliva and salivary tests.
Read the detailed description
Xerostomia is a condition related to both decrease in the amount of saliva produced and a change in its composition, therefore causing dry mouth.It can cause severe decline in quality of life and up to date, there have been few effective treatments for xerostomia.
The purpose of the current trial is to investigate the effect of herbal extract granule named Yukmijihwang-tang (YMT) on dry mouth. The trial is a randomized, double-blinded, placebo-controlled, 2-arm, 2-centered study. Ninety-six patients with xerostomia will be randomly assigned to one of the 2 groups consisting of YMT or placebo. The assigned treatments will last for 8 weeks and the follow-up period will be 2 weeks.
The primary outcomes are Visual analogue scale (VAS) for xerostomia.
The present study is designed to examine the safety and efficacy of YMT on xerostomia. Our study provides the clinical evidence of a new therapeutic strategy for xerostomia.
- Conditions
- Xerostomia
- Being tested
- Herbal extract granule, Placebo herbal extract granule
- Keywords
- Xerostomia, Yukmijihwang-tang, Yin-Deficiency, Visual analogue scale, Dry mouth symptom questionnaire
- Medical subject headings
- Xerostomia, Yin Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herbal extract granuleDietary supplement
Also called Hexalong Granule
The herbal extract granule, Yukmijihwang-tang granule, consists of 6 herbs. Ingredients: Rehmanniae Radix, Deoscoreae Radix, Corni Fructus, Hoelen, Alismatis Radix, Paeoniae Radicis Cortex. Dosage and frequency: 1 pack (3g), 3 packs per day (2 hours after morning, afternoon and evening meal)
Placebo herbal extract granuleDietary supplement
Also called Hexalong Granule Placebo
The Yukmijihwang-tang_Placebo has the same form, color and flavor as experimental intervention (Yukmijihwang-tang). The dosage, frequency and duration is also the same as experimental intervention (Yukmijihwang-tang).
| Study group | Role | What they receive |
|---|---|---|
| Yukmijihwang-tang | Experimental | Yukmijihwang-tang: Real herbal extract granule Receives: Dietary Supplement: Herbal extract granule |
| Yukmijihwang-tang_Placebo | Placebo comparator | Yukmijihwang-tang_Placebo: Placebo herbal extract granule Receives: Dietary Supplement: Placebo herbal extract granule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS) for xerostomia
A 100 mm measurement instrument will be given to the patient and he will be instructed to indicate his severity of xerostomia in relation to the 2 extremes (0: no fatigue, 100: very severe fatigue).
Measured: Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week)
Secondary outcomes (4)
Unstimulated Salivary Flow Rate (USFR) and Stimulated salivary flow rate (SSFR)
Measured: Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week)
Residual saliva
Measured: Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week)
Salivary IgA, Chromogranin A, Cortisol
Measured: Visit 1(0week), Visit 3(8week)
Dry Mouth Symptom Questionnaire(DMSQ)
DMSQ is composed of 10 questions associated with the severity of xerostomia and various behaviors related to xerostomia
Measured: Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionSep 2013 (estimated)
- Study completionNov 2013 (estimated)
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea Health Industry Development Institute
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jin-sung Kim, Korea Health Industry Development Institute
- Investigators
- Jinsung Kim, doctorate, Principal investigator, Kyung Hee University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01579877
- Sponsor's protocol ID
- KOMCIRB2011-28/KHNMC-OH-IRB20
- Status last verified
- May 2013
- First submitted
- 13 Apr 2012
- Last updated
- 14 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Han G, Park JW, Ko SJ, Son J, Seon J, Kim J, Kim S, Yeo I, Ryu B, Kim J. Yukmijihwang-tang for the treatment of xerostomia in the elderly: study protocol for a randomized, double-blind, placebo-controlled, two-center trial. Trials. 2013 Sep 3;14:281. doi: 10.1186/1745-6215-14-281.
PubMed 24004451
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Yukmijihwang-tang on Xerostomia in the Elderly: A Randomized,Double-blind, Placebo-controlled, Two-center Trial
- ClinicalTrials.gov ID
- NCT01579877
- Acronym / sponsor ID
- KOMCIRB2011-28/KHNMC-OH-IRB20
- Conditions
- Xerostomia
- Keywords
- Xerostomia, Yukmijihwang-tang, Yin-Deficiency, Visual analogue scale, Dry mouth symptom questionnaire
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Korea Health Industry Development InstituteOther government
- Study start
- Apr 2012
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 18 Apr 2012 (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.
The aims of this study are to investigate the effect of famous herbal formula extract on xerostomia, and to determine whether this formula affect various xerostomia-related questionnaires, salivary flow rate, residual saliva and salivary tests.
Detailed description
Xerostomia is a condition related to both decrease in the amount of saliva produced and a change in its composition, therefore causing dry mouth.It can cause severe decline in quality of life and up to date, there have been few effective treatments for xerostomia.
The purpose of the current trial is to investigate the effect of herbal extract granule named Yukmijihwang-tang (YMT) on dry mouth. The trial is a randomized, double-blinded, placebo-controlled, 2-arm, 2-centered study. Ninety-six patients with xerostomia will be randomly assigned to one of the 2 groups consisting of YMT or placebo. The assigned treatments will last for 8 weeks and the follow-up period will be 2 weeks.
The primary outcomes are Visual analogue scale (VAS) for xerostomia.
The present study is designed to examine the safety and efficacy of YMT on xerostomia. Our study provides the clinical evidence of a new therapeutic strategy for xerostomia.
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 |
|---|---|---|
| Yukmijihwang-tang | Experimental | Dietary Supplement: Herbal extract granuleYukmijihwang-tang: Real herbal extract granule |
| Yukmijihwang-tang_Placebo | Placebo comparator | Dietary Supplement: Placebo herbal extract granuleYukmijihwang-tang_Placebo: Placebo herbal extract granule |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age of 60 - 80
- The visual analog scale for xerostomia must represent more than 4 points during 2wks prior to enrollment
- One who has less than 0.3 ml/min of unstimulated salivary flow rate
- One who has complained of xerostomia for at least 3months
- One who is able to read, write, hear, see something
Key exclusion criteria (5 listed)
- One who is taking the treatment for autoimmune disease such as sjogren's disease, rheumatic disease, systemic lupus erythematosus etc
- One who has the history of taking radiotherapy on head and neck or history of organ transplantation
- One who has severe mental illness such as depression
- One who takes oriental medicine or health functional food within 2 wks before enrollment
- One who takes the remedies on the purpose of relieving xerostomia such as pilocarpine, cevimeline, gargle solution, frequent gum use, intra oral devices and toothpaste etc.
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 |
|---|---|---|
| Herbal extract granuleAlso: Hexalong GranuleThe herbal extract granule, Yukmijihwang-tang granule, consists of 6 herbs. Ingredients: Rehmanniae Radix, Deoscoreae Radix, Corni Fructus, Hoelen, Alismatis Radix, Paeoniae Radicis Cortex. Dosage and frequency: 1 pack (3g), 3 packs per day (2 hours after morning, afternoon and evening meal) | Dietary supplement | Yukmijihwang-tang |
| Placebo herbal extract granuleAlso: Hexalong Granule PlaceboThe Yukmijihwang-tang_Placebo has the same form, color and flavor as experimental intervention (Yukmijihwang-tang). The dosage, frequency and duration is also the same as experimental intervention (Yukmijihwang-tang). | Dietary supplement | Yukmijihwang-tang_Placebo |
Primary outcome
Visual Analogue Scale (VAS) for xerostomia
Time frame: Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week)
A 100 mm measurement instrument will be given to the patient and he will be instructed to indicate his severity of xerostomia in relation to the 2 extremes (0: no fatigue, 100: very severe fatigue).
4 secondary outcomes
Unstimulated Salivary Flow Rate (USFR) and Stimulated salivary flow rate (SSFR)
Time frame: Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week)
Residual saliva
Time frame: Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week)
Salivary IgA, Chromogranin A, Cortisol
Time frame: Visit 1(0week), Visit 3(8week)
Dry Mouth Symptom Questionnaire(DMSQ)
Time frame: Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2013.
- Derived from this study: PubMed 24004451Han G, Park JW, Ko SJ, Son J, Seon J, Kim J, Kim S, Yeo I, Ryu B, Kim J. Yukmijihwang-tang for the treatment of xerostomia in the elderly: study protocol for a randomized, double-blind, placebo-controlled, two-center trial. Trials. 2013 Sep 3;14:281. doi: 10.1186/1745-6215-14-281.
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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.
Jinsung Kim, doctorate principal investigator
Kyung Hee University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Herbal extract granule in people with Xerostomia, run by Korea Health Industry Development Institute 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 7 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: status not confirmed, as of the sponsor's last update on 14 May 2013. 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.
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?
Contact Jinsung Kim, doctorate (+82-2-958-8895, oridoc@khu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) for xerostomia (time frame: Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week)). 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 NCT01579877, 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 14 May 2013.