Xerostomia Clinical Trial
Official title:
Efficacy of Yukmijihwang-tang on Xerostomia in the Elderly: A Randomized,Double-blind, Placebo-controlled, Two-center Trial
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.
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Kyung Hee University Oriental Medicine Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Korea Health Industry Development Institute |
Korea, Republic of,
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 |
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