Treatment of Xerostomia by Herbal Preparation

Xerostomia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01579877
• Other study ID #: KOMCIRB2011-28/KHNMC-OH-IRB20
• Status: Recruiting
• Phase: N/A
• First received: April 13, 2012
• Last updated: May 12, 2013
• Start date: April 2012
• Est. completion date: November 2013

Study information

• Verified date: May 2013
• Source: Korea Health Industry Development Institute
• Contact: Jinsung Kim, doctorate
• Phone: +82-2-958-8895
• Email: oridoc[@]khu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: November 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Xerostomia

Intervention

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)
• 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).

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee University Oriental Medicine Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea Health Industry Development Institute

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week)	No
Secondary	Unstimulated Salivary Flow Rate (USFR) and Stimulated salivary flow rate (SSFR)		Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week)	No
Secondary	Residual saliva		Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week)	No
Secondary	Salivary IgA, Chromogranin A, Cortisol		Visit 1(0week), Visit 3(8week)	No
Secondary	Dry Mouth Symptom Questionnaire(DMSQ)	DMSQ is composed of 10 questions associated with the severity of xerostomia and various behaviors related to xerostomia	Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week)	No