Treatment of Xerostomia by Herbal Preparation

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.

Study Overview

• Status: Unknown
• Conditions: Xerostomia
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 130-872
    • Recruiting
    • Kyung Hee University Oriental Medicine Hospital
    • Contact: Jinsung Kim, doctorate; Phone Number: +82-2-958-8895; Email: oridoc@khu.ac.kr
    • Contact: Jae-Woo Park, doctorate; Phone Number: +82-2-440-6219; Email: pjw2907@hanmail.net
    • Sub-Investigator: Jae-Woo Park, doctorate

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Hexalong Granule Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unstimulated Salivary Flow Rate (USFR) and Stimulated salivary flow rate (SSFR)		Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week)
Residual saliva		Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week)
Salivary IgA, Chromogranin A, Cortisol		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	Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week)

Collaborators and Investigators

• Sponsor: Korea Health Industry Development Institute
• Investigators: Principal Investigator: Jinsung Kim, doctorate, Kyung Hee University Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Anticipated): September 1, 2013
• Study Completion (Anticipated): November 1, 2013

Study Registration Dates

• First Submitted: April 13, 2012
• First Submitted That Met QC Criteria: April 16, 2012
• First Posted (Estimate): April 18, 2012

Study Record Updates

• Last Update Posted (Estimate): May 14, 2013
• Last Update Submitted That Met QC Criteria: May 12, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Xerostomia; Visual analogue scale; Yukmijihwang-tang; Yin-Deficiency; Dry mouth symptom questionnaire
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Xerostomia
• Other Study ID Numbers: KOMCIRB2011-28/KHNMC-OH-IRB20