Treatment of Xerostomia by Herbal Preparation
This study is currently recruiting participants.
Verified May 2013 by Korea Health Industry Development Institute
Sponsor:
Korea Health Industry Development Institute
Information provided by (Responsible Party):
Jin-sung Kim, Korea Health Industry Development Institute
ClinicalTrials.gov Identifier:
NCT01579877
First received: April 13, 2012
Last updated: May 12, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Xerostomia |
Dietary Supplement: Herbal extract granule Dietary Supplement: Placebo herbal extract granule |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Efficacy of Yukmijihwang-tang on Xerostomia in the Elderly: A Randomized,Double-blind, Placebo-controlled, Two-center Trial |
Resource links provided by NLM:
Further study details as provided by Korea Health Industry Development Institute:
Primary Outcome Measures:
- Visual Analogue Scale (VAS) for xerostomia [ Time Frame: Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week) ] [ Designated as safety issue: No ]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).
Secondary Outcome Measures:
- Unstimulated Salivary Flow Rate (USFR) and Stimulated salivary flow rate (SSFR) [ Time Frame: Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week) ] [ Designated as safety issue: No ]
- Residual saliva [ Time Frame: Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week) ] [ Designated as safety issue: No ]
- Salivary IgA, Chromogranin A, Cortisol [ Time Frame: Visit 1(0week), Visit 3(8week) ] [ Designated as safety issue: No ]
- Dry Mouth Symptom Questionnaire(DMSQ) [ Time Frame: Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week) ] [ Designated as safety issue: No ]DMSQ is composed of 10 questions associated with the severity of xerostomia and various behaviors related to xerostomia
| Estimated Enrollment: | 96 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Yukmijihwang-tang
Yukmijihwang-tang: Real herbal extract granule
|
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)
Other Name: Hexalong Granule
|
|
Placebo Comparator: Yukmijihwang-tang_Placebo
Yukmijihwang-tang_Placebo: Placebo herbal extract granule
|
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).
Other Name: Hexalong Granule Placebo
|
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.
Eligibility| Ages Eligible for Study: | 60 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01579877
Contacts
| Contact: Jinsung Kim, doctorate | +82-2-958-8895 | oridoc@khu.ac.kr |
| Contact: Jae-Woo Park, doctorate | +82-2-440-6219 | pjw2907@hanmail.net |
Locations
| Korea, Republic of | |
| Kyung Hee University Oriental Medicine Hospital | Recruiting |
| Seoul, Korea, Republic of, 130-872 | |
| Contact: Jinsung Kim, doctorate +82-2-958-8895 oridoc@khu.ac.kr | |
| Contact: Jae-Woo Park, doctorate +82-2-440-6219 pjw2907@hanmail.net | |
| Sub-Investigator: Jae-Woo Park, doctorate | |
Sponsors and Collaborators
Korea Health Industry Development Institute
Investigators
| Principal Investigator: | Jinsung Kim, doctorate | Kyung-Hee University Hospital |
More Information
No publications provided
| Responsible Party: | Jin-sung Kim, Full professor, Korea Health Industry Development Institute |
| ClinicalTrials.gov Identifier: | NCT01579877 History of Changes |
| Other Study ID Numbers: | KOMCIRB2011-28/KHNMC-OH-IRB20 |
| Study First Received: | April 13, 2012 |
| Last Updated: | May 12, 2013 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Korea Health Industry Development Institute:
|
Xerostomia Yukmijihwang-tang Yin-Deficiency Visual analogue scale Dry mouth symptom questionnaire |
Additional relevant MeSH terms:
|
Xerostomia Salivary Gland Diseases Mouth Diseases Stomatognathic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013