- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04272437
TRA for Preventing Symptomatic Urinary Tract Infection Among High-risk Elderly Residing in Nursing Homes
Concentrated Traditional Chinese Herbal Extract Granules TRA for Preventing Symptomatic Urinary Tract Infection Among High-risk Elderly Residing in Nursing Homes-A Randomized Placebo-Controlled Trial
Urinary tract infection (UTI) is one of the most common infection in nursing home residents, and symptomatic UTI in the nursing home setting is the most frequent reason for hospitalization and antimicrobial therapy in Taiwan. Increasing antimicrobial resistance has stimulated interest in non-antibiotic prophylaxis of UTI. The primary aim of this study is to test the efficacy of standardized concentrated herbal extract granules TRA in the reduction of the incidence of symptomatic UTI and associated hospitalization in high-risk nursing home residents. These aims were accomplished by conducting a double-blind randomized placebo-controlled efficacy trial of TRA daily versus placebo granules in a cohort of Changhua County nursing home residents in Taiwan.
A total of 164 nursing home residents at high risk for UTI were be enrolled. A permuted block design with a block size of 6 were conducted. And a Stratification by nursing home accounted for potentially different standards of care. Subjects will be randomly assigned to receive either TRA (10 g) or the placebo two times per day for 42 consecutive days. All subjects in both groups will also continuously receive their daily medication without any dose or medicine change. Urinalysis was evaluated before and after administration. Independent statisticians performed the data analysis at the end of the trial.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Changhua city, Taiwan, 500
- Dept. of Traditional Chinese Medicine, Changhua Christian Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Nursing home residents;
- 65 years or older; and
High UTI risk
- Catheterization (>1 m/o),
- Diabetes mellitus, or
- At least one UTI in the preceding year.
Exclusion Criteria:
- Not expected to be in the nursing home for at least one month (i.e. pending discharge, terminal life expectancy < 1 month);
- On chronic suppressive antibiotic or anti-infective therapy
- On dialysis for end stage renal disease; or
- previous ADR to herbals.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: TRA group
"Tokoro Combination" and "Rehmannia and Akebia Formula" (TRA) in each one batch number were manufactured by Chuang Song Zong Pharmaceutical Co., Ltd., a famous manufacturer of concentrated herbal extract granules in agreement with the standards of good manufacturing practices (GMP) in Kaohsiung City, Taiwan. TRA contains "Tokoro Combination" and "Rehmannia and Akebia Formula" "Tokoro Combination" and "Rehmannia and Akebia Formula" consists of Dioscorea Hypoglaucae Rhizoma, Acori Graminei Rhizoma, Linderae Radix, Alpiniae Oxyphyllae Fructus, Poria, Rehmanniae Radix, Akebiae Caulis, Lophatheri Hebra, and Glycyrrhizae Radix at a 2:2:2:2:1:1.3:1.3:1.3:2.5 ratio. |
Concentrated herbal extract granules Subjects in the TRA group orally ingested one package of granules (5 g/package) two times daily with warm water after lunch and dinner for 6 consecutive weeks.
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PLACEBO_COMPARATOR: placebo group
The placebo was also prepared as granules by Chung Song Zong Pharmaceutical Co., Ltd., and the packaging of the placebo was identical to that of TRA.
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Subjects in the placebo group orally ingested one package of granules (5 g/package) two times daily with warm water after lunch and dinner for 6 consecutive weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Episodes of Symptomatic UTI During Administration
Time Frame: 42 days
|
Nursing home medical record and National Health Insurance(NHI) IC cards checking were both performed every week for the symptomatic UIT diagnosis and hospitalization recording.
Suspected UTI episodes that were recorded in nursing home medical record were reviewed by chart review, symptoms, signs, and laboratory data were recorded, two investigators determined if the definition of symptomatic UTI was met.
|
42 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Episodes of Symptomatic UTI Onset From First Administration Till 180 Days
Time Frame: 180 days.
|
Nursing home medical record and National Health Insurance(NHI) IC cards checking were both performed every week for the symptomatic UIT diagnosis and hospitalization recording.
Suspected UTI episodes that were recorded in nursing home medical record were reviewed by chart review, symptoms, signs, and laboratory data were recorded, two investigators determined if the definition of symptomatic UTI was met.
|
180 days.
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Accumulated Rate of Symptomatic UTI During Administration
Time Frame: 42 days.
|
Nursing home medical record and National Health Insurance(NHI) IC cards checking were both performed every week for the symptomatic UIT diagnosis and hospitalization recording.
Suspected UTI episodes that were recorded in nursing home medical record were reviewed by chart review, symptoms, signs, and laboratory data were recorded, two investigators determined if the definition of symptomatic UTI was met.
|
42 days.
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Accumulated Rate of Symptomatic UTI Onset From First Administration Till 180 Days
Time Frame: 180 days.
|
Nursing home medical record and National Health Insurance(NHI) IC cards checking were both performed every week for the symptomatic UIT diagnosis and hospitalization recording.
Suspected UTI episodes that were recorded in nursing home medical record were reviewed by chart review, symptoms, signs, and laboratory data were recorded, two investigators determined if the definition of symptomatic UTI was met.
|
180 days.
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The Change of Urinalysis From Baseline to 42 Days
Time Frame: 42 days
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Sterile urine specimen collection from a foley catheter or clean catch midstream urine for urinalysis were obtained from baseline to 6 weeks for each participant for study purposes. Changes in urine species were texted by using chemical strip and urine sediment method in the Department of Laboratory Medicine at ChungHua Christrian Hospital. The items for urinalysis were as following: specific gravity, pH value, protein, nitrite, WBC esterase, RBC( in high-power field), RBC( in high-power field), squamous epithelial cell( in high-power field), bacteria( in high-power field), etc. |
42 days
|
Number of Deaths Onset From First Administration Till 180 Days
Time Frame: 180 days
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All-cause deaths were recorded.
|
180 days
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Adverse Events in Participants
Time Frame: 42 days
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42 days
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOHW107-CMAP-M-114-122113
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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