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Urinary Tract InfectionsPhase 2NCT04272437

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

A Phase 2 study testing Concentrated herbal extract granules TRA in people with Urinary Tract Infections, run by Changhua Christian Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Urinary Tract Infections
What is being tested?
Concentrated herbal extract granules TRA
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
162 participants
Where
1 siteTaiwan
Study dates
15 Jun 2017to 3 Mar 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Dept. of Traditional Chinese Medicine, Changhua Christian Hospital

    Changhua, 500

Other trials in Taiwan

About this study

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

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.

Read the 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.

Being tested
Concentrated herbal extract granules TRA, Placebo
Keywords
Nursing Homes, TCM herbal extracts
Medical subject headings
Urinary Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Concentrated herbal extract granules TRADrug

    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.

  • PlaceboDrug

    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.

Study groups in NCT04272437
Study groupRoleWhat they receive
TRA groupExperimental"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.
Receives: Drug: Concentrated herbal extract granules TRA
placebo groupPlacebo 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 42 days

Secondary outcomes (5)

  1. Number of Episodes of Symptomatic UTI Onset From First Administration Till 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.

    Measured: 180 days.

  2. Accumulated Rate 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.

    Measured: 42 days.

  3. Accumulated Rate of Symptomatic UTI Onset From First Administration Till 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.

    Measured: 180 days.

  4. The Change of Urinalysis From Baseline to 42 Days

    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.

    Measured: 42 days

  5. Number of Deaths Onset From First Administration Till 180 Days

    All-cause deaths were recorded.

    Measured: 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2020
  2. Study start15 Jun 2017
  3. Primary completion31 Dec 2018
  4. Study completion3 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants were randomly assigned to receive intervention or placebo.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04272437
Sponsor's protocol ID
MOHW107-CMAP-M-114-122113
Status last verified
Feb 2020
First submitted
10 Feb 2020
Last updated
17 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Concentrated herbal extract granules TRA in people with Urinary Tract Infections, run by Changhua Christian Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Episodes of Symptomatic UTI During Administration (time frame: 42 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04272437.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.

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