Clinical trial NCT04272437: TRA for Preventing Symptomatic Urinary Tract Infection Among High-risk Elderly Residing in Nursing Homes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urinary Tract Infections
Keywords: Nursing Homes
TCM herbal extracts
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health and Welfare, Taiwan
First posted: 2020-02-17
Enrollment: 162
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomly assigned to receive intervention or placebo.
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Episodes of Symptomatic UTI During Administration
timeFrame: 42 days
Secondary outcomes:
measure: Number of Episodes of Symptomatic UTI Onset From First Administration Till 180 Days
timeFrame: 180 days.
measure: Accumulated Rate of Symptomatic UTI During Administration
timeFrame: 42 days.
measure: Accumulated Rate of Symptomatic UTI Onset From First Administration Till 180 Days
timeFrame: 180 days.
measure: The Change of Urinalysis From Baseline to 42 Days
timeFrame: 42 days
measure: Number of Deaths Onset From First Administration Till 180 Days
timeFrame: 180 days
Other outcomes:
measure: Number of Adverse Events in Participants
timeFrame: 42 days
Locations:
city: Changhua city
country: Taiwan
facility: Dept. of Traditional Chinese Medicine, Changhua Christian Hospital
Study officials:
References: