Treatment of Xerostomia by Herbal Preparation

Not Applicable

• Conditions: Xerostomia
• Interventions: Dietary Supplement: Placebo herbal extract granule; Dietary Supplement: Herbal extract granule

• Registration Number: NCT01579877
• Lead Sponsor: Korea Health Industry Development Institute

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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-13
• Study First Submitted QC: 2012-04-16
• Study First Posted: 2012-04-18
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-12
• Last Update Posted: 2013-05-14
• Primary Completion: 2013-09
• Study Completion: 2013-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Yukmijihwang-tang_Placebo	Placebo herbal extract granule	Yukmijihwang-tang_Placebo: Placebo herbal extract granule
Yukmijihwang-tang	Herbal extract granule	Yukmijihwang-tang: Real herbal extract granule

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS) for xerostomia	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

Name	Time	Method
Residual saliva	Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week)
Unstimulated Salivary Flow Rate (USFR) and Stimulated salivary flow rate (SSFR)	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)	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

Trial Locations

Locations (1)

Kyung Hee University Oriental Medicine Hospital; 🇰🇷 Seoul, Korea, Republic of