Treatment of Xerostomia by Herbal Preparation

Korea Health Industry Development Institute

Status: Unknown

Conditions: Xerostomia

Treatments: Dietary Supplement: Herbal extract granule; Dietary Supplement: Placebo herbal extract granule

Study type: Interventional

Funder types: Other

Identifiers

NCT01579877

KOMCIRB2011-28/KHNMC-OH-IRB20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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96 participants in 2 patient groups, including a placebo group

Yukmijihwang-tang

Experimental group

Description:

Yukmijihwang-tang: Real herbal extract granule

Treatment:

Dietary Supplement: Herbal extract granule

Yukmijihwang-tang_Placebo

Placebo Comparator group

Description:

Yukmijihwang-tang_Placebo: Placebo herbal extract granule

Treatment:

Dietary Supplement: Placebo herbal extract granule