Ignite Creation Date:
2024-05-06 @ 2:17 PM
Last Modification Date:
2024-10-26 @ 1:28 PM
Study NCT ID:
NCT04272437
Status:
COMPLETED
Last Update Posted:
2020-02-17
First Post:
2020-02-10
Brief Title:
TRA for Preventing Symptomatic Urinary Tract Infection Among High-risk Elderly Residing in Nursing Homes
Sponsor:
Changhua Christian Hospital
Organization:
Changhua Christian Hospital
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
The standardized concentrated herbal extract granules TRA were the combination of Tokoro CombinationPi-Hsieh-Fen-Ching-Yin Extract Granules and Rehmannia and Akebia Formula Dao Chi San Extract Powder Tokoro Combination and Rehmannia and Akebia Formula in each one batch number were used manufactured by Chuang Song Zong Pharmaceutical Co Ltd a famous GMP manufacturer of concentrated herbal extract granules in agreement with international standards The TRA was prepared in small granules including concentrated herbal extract granules of Tokoro Combination50 and Rehmannia and Akebia Formula 50 Both medicines have already been approved by the Ministry of Health and Welfare in Taiwan as ethical drugs TRA granules were packed in oblique glassine packages The placebo was also prepared as granules by Chuang Song Zong Pharmaceutical Co Ltd and the packaging of the placebo was identical to that of TRA The chemical composition of TRA was analyzed and profiled by using a high performance liquid chromatography HPLC The major components were diosgenin yamogenin betulin oleanolic acid hederagenin akeboside β-sitosterol stigmasterol inositol catalpol glycyrrhizin etc
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None