Treatment of Xerostomia by Herbal Preparation

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Korea Health Industry Development Institute
Sponsor:
Information provided by (Responsible Party):
Jin-sung Kim, Korea Health Industry Development Institute
ClinicalTrials.gov Identifier:
NCT01579877
First received: April 13, 2012
Last updated: May 12, 2013
Last verified: May 2013
  Purpose

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 Intervention
Xerostomia
Dietary Supplement: Herbal extract granule
Dietary Supplement: Placebo herbal extract granule

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Yukmijihwang-tang on Xerostomia in the Elderly: A Randomized,Double-blind, Placebo-controlled, Two-center Trial

Resource links provided by NLM:


Further study details as provided by Korea Health Industry Development Institute:

Primary Outcome Measures:
  • Visual Analogue Scale (VAS) for xerostomia [ Time Frame: Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week) ] [ Designated as safety issue: No ]
    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:
  • 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) ] [ Designated as safety issue: No ]
  • Residual saliva [ Time Frame: Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week) ] [ Designated as safety issue: No ]
  • Salivary IgA, Chromogranin A, Cortisol [ Time Frame: Visit 1(0week), Visit 3(8week) ] [ Designated as safety issue: No ]
  • Dry Mouth Symptom Questionnaire(DMSQ) [ Time Frame: Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week) ] [ Designated as safety issue: No ]
    DMSQ is composed of 10 questions associated with the severity of xerostomia and various behaviors related to xerostomia


Estimated Enrollment: 96
Study Start Date: April 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Korea Health Industry Development Institute

Additional 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
Study First Received: April 13, 2012
Last Updated: May 12, 2013
Health Authority: Korea: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 20, 2014