TRA for Preventing Symptomatic Urinary Tract Infection Among High-risk Elderly Residing in Nursing Homes

Changhua Christian Medical Foundation

Status and phase: Completed; Phase 2

Conditions: Urinary Tract Infections

Treatments: Drug: Concentrated herbal extract granules TRA; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04272437

MOHW107-CMAP-M-114-122113

Details and patient eligibility

About

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.

Full description

The standardized concentrated herbal extract granules TRA were the combination of "Tokoro Combination(Pi-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 Combination"(50%) 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.

Enrollment: 162 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Nursing home residents;

2. 65 years or older; and

3. High UTI risk

   • Catheterization (>1 m/o),
   • Diabetes mellitus, or
   • At least one UTI in the preceding year.

Exclusion criteria

1. Not expected to be in the nursing home for at least one month (i.e. pending discharge, terminal life expectancy < 1 month);
2. On chronic suppressive antibiotic or anti-infective therapy
3. On dialysis for end stage renal disease; or
4. previous ADR to herbals.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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162 participants in 2 patient groups, including a placebo group

TRA group

Experimental group

Description:

"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.

Treatment:

Drug: Concentrated herbal extract granules TRA

placebo group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo