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
1 other identifier
interventional
162
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 3, 2019
CompletedFirst Submitted
Initial submission to the registry
February 10, 2020
CompletedFirst Posted
Study publicly available on registry
February 17, 2020
CompletedFebruary 17, 2020
February 1, 2020
1.5 years
February 10, 2020
February 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Episodes of Symptomatic UTI During Administration
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 Outcomes (5)
Number of Episodes of Symptomatic UTI Onset From First Administration Till 180 Days
180 days.
Accumulated Rate of Symptomatic UTI During Administration
42 days.
Accumulated Rate of Symptomatic UTI Onset From First Administration Till 180 Days
180 days.
The Change of Urinalysis From Baseline to 42 Days
42 days
Number of Deaths Onset From First Administration Till 180 Days
180 days
Other Outcomes (1)
Number of Adverse Events in Participants
42 days
Study Arms (2)
TRA group
EXPERIMENTAL"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.
placebo group
PLACEBO COMPARATORThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Nursing home residents;
- years or older; and
- High UTI risk
- Catheterization (\>1 m/o),
- Diabetes mellitus, or
- At least one UTI in the preceding year.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept. of Traditional Chinese Medicine, Changhua Christian Hospital
Changhua, 500, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Participants were randomly assigned to take either TRA or placebo. Participants in the two groups orally ingested one package of granules (5 g/package) two times daily after lunch and dinner. The placebo was prepared as granules by Chuang Song Zong Pharmaceutical Co., Ltd, and the packaging of the placebo was identical to that of herbal extract granules. During the trial, neither the care providers(including family numbers and nursing-home colleagues) nor investigators ( assist doctors or nurses ) were aware of the group.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2020
First Posted
February 17, 2020
Study Start
June 15, 2017
Primary Completion
December 31, 2018
Study Completion
March 3, 2019
Last Updated
February 17, 2020
Record last verified: 2020-02