Treatment of Xerostomia by Herbal Preparation
Efficacy of Yukmijihwang-tang on Xerostomia in the Elderly: A Randomized,Double-blind, Placebo-controlled, Two-center Trial
1 other identifier
interventional
96
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 13, 2012
CompletedFirst Posted
Study publicly available on registry
April 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedMay 14, 2013
May 1, 2013
1.4 years
April 13, 2012
May 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (4)
Unstimulated Salivary Flow Rate (USFR) and Stimulated salivary flow rate (SSFR)
Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week)
Residual saliva
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)
Study Arms (2)
Yukmijihwang-tang
EXPERIMENTALYukmijihwang-tang: Real herbal extract granule
Yukmijihwang-tang_Placebo
PLACEBO COMPARATORYukmijihwang-tang\_Placebo: Placebo herbal extract granule
Interventions
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)
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).
Eligibility Criteria
You may qualify if:
- Age of 60 - 80
- The visual analog scale for xerostomia must represent more than 4 points during 2wks prior to enrollment
- One who has less than 0.3 ml/min of unstimulated salivary flow rate
- One who has complained of xerostomia for at least 3months
- One who is able to read, write, hear, see something
- One who agree on not taking other therapies during experimental period
- One who agree on consent form
You may not qualify if:
- One who is taking the treatment for autoimmune disease such as sjogren's disease, rheumatic disease, systemic lupus erythematosus etc
- One who has the history of taking radiotherapy on head and neck or history of organ transplantation
- One who has severe mental illness such as depression
- One who takes oriental medicine or health functional food within 2 wks before enrollment
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kyung Hee University Oriental Medicine Hospital
Seoul, Seoul, 130-872, South Korea
Related Publications (1)
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.
PMID: 24004451DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jinsung Kim, doctorate
Kyung Hee University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full professor
Study Record Dates
First Submitted
April 13, 2012
First Posted
April 18, 2012
Study Start
April 1, 2012
Primary Completion
September 1, 2013
Study Completion
November 1, 2013
Last Updated
May 14, 2013
Record last verified: 2013-05