Clinical trial NCT01579877: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Xerostomia
Keywords: Xerostomia
Yukmijihwang-tang
Yin-Deficiency
Visual analogue scale
Dry mouth symptom questionnaire
Lead sponsor: Korea Health Industry Development Institute
Sponsor class: OTHER_GOV
First posted: 2012-04-18
Enrollment: 96
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Visual Analogue Scale (VAS) for xerostomia
timeFrame: Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week)
Secondary outcomes:
measure: Unstimulated Salivary Flow Rate (USFR) and Stimulated salivary flow rate (SSFR)
timeFrame: Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week)
measure: Residual saliva
timeFrame: Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week)
measure: Salivary IgA, Chromogranin A, Cortisol
timeFrame: Visit 1(0week), Visit 3(8week)
measure: Dry Mouth Symptom Questionnaire(DMSQ)
timeFrame: Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Oriental Medicine Hospital
Study officials:
affiliation: Kyung Hee University Hospital
name: Jinsung Kim, doctorate
role: PRINCIPAL_INVESTIGATOR
References:
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.