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Treatment of Xerostomia by Herbal Preparation

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ClinicalTrials.gov Identifier: NCT01579877
Recruitment Status : Unknown
Verified May 2013 by Jin-sung Kim, Korea Health Industry Development Institute.
Recruitment status was:  Recruiting
First Posted : April 18, 2012
Last Update Posted : May 14, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Xerostomia Dietary Supplement: Herbal extract granule Dietary Supplement: Placebo herbal extract granule

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Yukmijihwang-tang on Xerostomia in the Elderly: A Randomized,Double-blind, Placebo-controlled, Two-center Trial
Study Start Date : April 2012
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dry Mouth
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Yukmijihwang-tang
Yukmijihwang-tang: Real herbal extract granule
Dietary Supplement: Herbal extract 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)
Other Name: Hexalong Granule
Placebo Comparator: Yukmijihwang-tang_Placebo
Yukmijihwang-tang_Placebo: Placebo herbal extract granule
Dietary Supplement: Placebo herbal extract granule
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).
Other Name: Hexalong Granule Placebo


Outcome Measures

Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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) ]
  2. Residual saliva [ Time Frame: Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week) ]
  3. Salivary IgA, Chromogranin A, Cortisol [ Time Frame: Visit 1(0week), Visit 3(8week) ]
  4. Dry Mouth Symptom Questionnaire(DMSQ) [ Time Frame: Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week) ]
    DMSQ is composed of 10 questions associated with the severity of xerostomia and various behaviors related to xerostomia


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age of 60 - 80
  2. The visual analog scale for xerostomia must represent more than 4 points during 2wks prior to enrollment
  3. One who has less than 0.3 ml/min of unstimulated salivary flow rate
  4. One who has complained of xerostomia for at least 3months
  5. One who is able to read, write, hear, see something
  6. One who agree on not taking other therapies during experimental period
  7. One who agree on consent form

Exclusion Criteria:

  1. One who is taking the treatment for autoimmune disease such as sjogren's disease, rheumatic disease, systemic lupus erythematosus etc
  2. One who has the history of taking radiotherapy on head and neck or history of organ transplantation
  3. One who has severe mental illness such as depression
  4. One who takes oriental medicine or health functional food within 2 wks before enrollment
  5. 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01579877


Contacts
Contact: Jinsung Kim, doctorate +82-2-958-8895 oridoc@khu.ac.kr
Contact: Jae-Woo Park, doctorate +82-2-440-6219 pjw2907@hanmail.net

Locations
Korea, Republic of
Kyung Hee University Oriental Medicine Hospital Recruiting
Seoul, Korea, Republic of, 130-872
Contact: Jinsung Kim, doctorate    +82-2-958-8895    oridoc@khu.ac.kr   
Contact: Jae-Woo Park, doctorate    +82-2-440-6219    pjw2907@hanmail.net   
Sub-Investigator: Jae-Woo Park, doctorate         
Sponsors and Collaborators
Korea Health Industry Development Institute
Investigators
Principal Investigator: Jinsung Kim, doctorate Kyung Hee University Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jin-sung Kim, Full professor, Korea Health Industry Development Institute
ClinicalTrials.gov Identifier: NCT01579877     History of Changes
Other Study ID Numbers: KOMCIRB2011-28/KHNMC-OH-IRB20
First Posted: April 18, 2012    Key Record Dates
Last Update Posted: May 14, 2013
Last Verified: May 2013

Keywords provided by Jin-sung Kim, Korea Health Industry Development Institute:
Xerostomia
Yukmijihwang-tang
Yin-Deficiency
Visual analogue scale
Dry mouth symptom questionnaire

Additional relevant MeSH terms:
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases