NCT01579877

Treatment of Xerostomia by Herbal Preparation

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Korea Health Industry Development Institute · Other Government
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Xerostomia

Interventions

Type	Name	Description
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)
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).

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-09-01
• Completion: 2013-11-01
• First posted: 2012-04-18
• Last updated: 2013-05-14

Locations

1 site across 1 country: South Korea