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Treatment of Xerostomia by Herbal Preparation

Primary Purpose

Xerostomia

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Herbal extract granule

Placebo herbal extract granule

About this trial

This is an interventional treatment trial for Xerostomia focused on measuring Xerostomia, Yukmijihwang-tang, Yin-Deficiency, Visual analogue scale, Dry mouth symptom questionnaire

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Kyung Hee University Oriental Medicine HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Yukmijihwang-tang

Yukmijihwang-tang_Placebo

Arm Description

Yukmijihwang-tang: Real herbal extract granule

Yukmijihwang-tang_Placebo: Placebo herbal extract granule

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Unstimulated Salivary Flow Rate (USFR) and Stimulated salivary flow rate (SSFR)

Residual saliva

Salivary IgA, Chromogranin A, Cortisol

Dry Mouth Symptom Questionnaire(DMSQ)

DMSQ is composed of 10 questions associated with the severity of xerostomia and various behaviors related to xerostomia

Full Information

NCT ID

NCT01579877

First Posted

April 13, 2012

Last Updated

May 12, 2013

Sponsor

Korea Health Industry Development Institute

1. Study Identification

Unique Protocol Identification Number

NCT01579877

Brief Title

Treatment of Xerostomia by Herbal Preparation

Official Title

Efficacy of Yukmijihwang-tang on Xerostomia in the Elderly: A Randomized,Double-blind, Placebo-controlled, Two-center Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Unknown status

Study Start Date

April 2012 (undefined)

Primary Completion Date

September 2013 (Anticipated)

Study Completion Date

November 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Korea Health Industry Development Institute

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Xerostomia

Keywords

Xerostomia, Yukmijihwang-tang, Yin-Deficiency, Visual analogue scale, Dry mouth symptom questionnaire

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Yukmijihwang-tang

Arm Type

Experimental

Arm Description

Yukmijihwang-tang: Real herbal extract granule

Arm Title

Yukmijihwang-tang_Placebo

Arm Type

Placebo Comparator

Arm Description

Yukmijihwang-tang_Placebo: Placebo herbal extract granule

Intervention Type

Dietary Supplement

Intervention Name(s)

Herbal extract granule

Other Intervention Name(s)

Hexalong Granule

Intervention Description

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)

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo herbal extract granule

Other Intervention Name(s)

Hexalong Granule Placebo

Intervention Description

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).

Primary Outcome Measure Information:

Title

Visual Analogue Scale (VAS) for xerostomia

Description

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).

Time Frame

Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week)

Secondary Outcome Measure Information:

Title

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)

Title

Residual saliva

Time Frame

Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week)

Title

Salivary IgA, Chromogranin A, Cortisol

Time Frame

Visit 1(0week), Visit 3(8week)

Title

Dry Mouth Symptom Questionnaire(DMSQ)

Description

DMSQ is composed of 10 questions associated with the severity of xerostomia and various behaviors related to xerostomia

Time Frame

Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jinsung Kim, doctorate

Phone

+82-2-958-8895

oridoc@khu.ac.kr

First Name & Middle Initial & Last Name or Official Title & Degree

Jae-Woo Park, doctorate

Phone

+82-2-440-6219

pjw2907@hanmail.net

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jinsung Kim, doctorate

Organizational Affiliation

Kyung Hee University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kyung Hee University Oriental Medicine Hospital

City

Seoul

ZIP/Postal Code

130-872

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jinsung Kim, doctorate

Phone

+82-2-958-8895

oridoc@khu.ac.kr

First Name & Middle Initial & Last Name & Degree

Jae-Woo Park, doctorate

Phone

+82-2-440-6219

pjw2907@hanmail.net

First Name & Middle Initial & Last Name & Degree

Jae-Woo Park, doctorate

12. IPD Sharing Statement

Citations:

PubMed Identifier

24004451

Citation

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.

Results Reference

derived

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Treatment of Xerostomia by Herbal Preparation

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