Evidence map›Paper›PMID 34895307›Full record

ArticleTrials2021

Clinical efficacy of Tailin formulation combined with continuous low-dose antimicrobial therapy for recurrent urinary tract infection: study protocol for a multicenter, double-blind, randomized, controlled clinical trial.

Tonglu Li, Yingru Xu, Xuezhong Gong

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.3field-weighted citation impact, top 38% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 3 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors at 1 institution in 1 country.

Tonglu LiDepartment of Nephrology, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, 274 Zhijiang Middle Road, Shanghai, 200071, China.
Yingru XuDepartment of Nephrology, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, 274 Zhijiang Middle Road, Shanghai, 200071, China.
Xuezhong GongDepartment of Nephrology, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, 274 Zhijiang Middle Road, Shanghai, 200071, China. shnanshan@hotmail.com.ORCID http://orcid.org/0000-0002-4496-7972
Shanghai University of Traditional Chinese Medicine · CN

Funding

national natural science foundation of china 81873280national natural science foundation of china 82074387shanghai leading academic discipline project No.02.ZY05.191311N
6 · The paper itself

Abstract

backgroundGiven the increasing rates of antimicrobial resistance (AMR), recurrent urinary tract infection (rUTI) is becoming refractory more and more. Antibiotic prophylaxis including continuous low-dose antibiotic therapy (CLAT), is the common treatment for rUTI of the world. However, the presumably adverse reactions caused by CLAT alone should be paid more attention. Studies indicated that Chinese herbal medicine (CHM) might be an available treatment method for rUTI. Tailin formulation (TLF) is a herbal prescription developed for the treatment of rUTI in the 2000s in Shanghai Municipal Hospital of Traditional Chinese Medicine. Our previous studies have shown TLF could prevent urinary tract infection both in pyelonephritis (PN) rat model and in PN patients. Additionally, our published data demonstrated TLF is helpful to reduce the recurrence of rUTI and protect renal tubular function in clinic. In order to find a novel treating project for rUTI to increase the clinical curative effect, we thus try to combine TLF with CLAT to treat rUTI and design an optimized, pragmatically clinical trial to evaluate the efficacy and safety of this project. METHODS/

designThis is a multicenter, double-blind, randomized, controlled clinical trial. We will enroll 200 eligible patients diagnosed with uncomplicated rUTI and then divide them randomly into two groups with a 1:1 ratio: TLF + CLAT group and placebo + CLAT group. This trial consists of two stages, a 12-week period of treatment and a 12-week period of post-treatment follow-up, respectively. The primary outcome will be the recurrence rate at the 12th week of the follow-up period; the second outcomes will be the post-treatment changes in renal and liver function; furthermore, traditional Chinese medicine (TCM) symptoms, non-infection-related physical signs, and subjective symptoms will be scored, and the number of episodes of each subject will be also recorded; meanwhile, vital signs indicators and serious adverse events (SAEs) will be monitored throughout the trial. DISCUSSION: This study will provide convictive research-derived data to evaluate clinical efficacy and safety of TLF combined with CLAT for rUTI, and provide an evidence-based recommendation for clinicians. Moreover, post-treatment changes in non-infection-related physical signs and subjective symptoms were included in the efficacy evaluation, which is important and more significant for assessing the clinical benefits for those rUTI patients.

trial registrationChinese Clinical Trial Registry ChiCTR2100041914 . Registered on 10 January 2021. Protocol date and version: September 12, 2020; version 1.

Indexed as

Anti-Infective AgentsUrinary Tract InfectionsAnimalsAnti-Bacterial AgentsChinaHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicRatsTreatment OutcomeAnti-Bacterial AgentsAnti-Infective AgentsContinuous low-dose antibiotic therapy (CLAT)Randomized controlled trial (RCT)Recurrent urinary tract infection (rUTI)Tailin formulationTraditional Chinese medicine (TCM)

Identifiers

PMID34895307
PMCPMC8665585
OpenAlexW4200592865

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.