Evidence map›Paper›PMID 31324199›Full record

ArticleTrials2019

Sanjin tablets for acute uncomplicated lower urinary tract infection (syndrome of dampness-heat in the lower jiao): protocol for randomized, double-blind, double-dummy, parallel control of positive drug, multicenter clinical trial.

Jian Lyu, Yan-Ming Xie, Zhan Gao, Jian-Wu Shen, Yue-Yi Deng, Song-Tao Xiang, Wen-Xi Gao, Wen-Tong Zeng, Chun-He Zhang, Dan-Hui Yi and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03658291 (Sanjin Tablets for the Treatment of Acute Simple Lower Urinary Tract Infection and Its Influence on Recurrence Rate), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.1field-weighted citation impact, top 22% 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.

NCT03658291 phase4unknown statusnot on this map

Sanjin Tablets for the Treatment of Acute Simple Lower Urinary Tract Infection and Its Influence on Recurrence Rate: a Randomized, Double Blind, Parallel Control of Positive Drugs, Multi-center Clinical Study

TypeinterventionalSponsorChina Academy of Chinese Medical SciencesRan2019 to 2019Enrolled252ConditionsUrinary Tract Infection Lower AcuteArmsSanjin tablets, Sanjin tablets simulants, Levofloxacin
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 13 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Review
  5. Article
  6. Article
  7. Article
  8. 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

12 authors at 7 institutions in 1 country.

Jian LyuInstitute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, 100700, People's Republic of China.ORCID http://orcid.org/0000-0001-6518-622X
Yan-Ming XieInstitute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, 100700, People's Republic of China. ktzu2018@163.com.
Zhan GaoXiYuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, People's Republic of China. GaozhanMd.vip@163.com.
Jian-Wu ShenXiYuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, People's Republic of China.
Yue-Yi DengLonghua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, People's Republic of China.
Song-Tao XiangGuangdong Provincial Hospital of Traditional Chinese Medicine, Guangdong, 510120, People's Republic of China.
Wen-Xi GaoHubei Provincial Hospital of Traditional Chinese Medicine, Hubei, 430061, People's Republic of China.
Wen-Tong ZengAffiliated hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, People's Republic of China.
Chun-He ZhangYunnan Provincial Hospital of Traditional Chinese Medicine, Yunnan, 650021, People's Republic of China.
Dan-Hui YiSchool of Statistics, Renmin University of China, Beijing, 100872, People's Republic of China.
Lian-Xin WangInstitute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, 100700, People's Republic of China.
Zhi-Fei WangInstitute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, 100700, People's Republic of China.
Chinese Academy of Medical Sciences & Peking Union Medical College · CNChengdu University of Traditional Chinese Medicine · CNGuangdong Provincial Hospital of Traditional Chinese Medicine · CNHubei Provincial Hospital of Traditional Chinese Medicine · CNRenmin University of China · CNShanghai University of Traditional Chinese Medicine · CNYunnan Provincial Hospital of Traditional Chinese Medicine · CN

Funding

Fundamental Research Funds for the Central Public Welfare Research Institutes Z0546Research Project of Postgraduate Education and Teaching Reform of China Academy of Chinese Medical Sciences JG201703Scientific Research Innovation Team Project of China Academy of Chinese Medical Sciences PY1303the China International Food and Medicine Exchange Center of NMPA Commissioned Research Project "International Publicity on the Safety of Traditional Chinese Medicine" Z0531
6 · The paper itself

Abstract

backgroundAcute uncomplicated lower urinary tract infection (UTI) is one of the most common bacterial infections. Patients usually present with dysuria, urinary urgency, urinary frequency, and suprapubic pain or tenderness. Approximately 150 million people are diagnosed with UTI each year worldwide. The high recurrence rate of lower UTI is a common problem of clinical treatment. The misuse of antibiotics has led to the emergence of a number of resistant bacterial strains. Thus, traditional Chinese medicine is considered as an alternative option for treating acute uncomplicated lower UTI. Thus, this study aims to evaluate the efficacy and safety of Sanjin tablets (SJT) for the treatment of acute uncomplicated lower UTI, explore whether SJT can reduce or substitute the use of antibiotics, and reduce the recurrence rate in the treatment of acute uncomplicated lower UTI. METHODS/

designIn this study, a randomized, double-blind, double-dummy, parallel control of positive drug, multicenter clinical study will be established. A total of 252 patients with acute uncomplicated lower UTI (syndrome of dampness-heat in the lower jiao) will be randomly allocated in the ratio of 1:1:1 to three groups: experimental group; control group 1; and control group 2. The experimental group receives Sanjin tablets plus levofloxacin tablets (LT) placebo; the control group 1 receives LT plus SJT placebo; and the control group 2 receives SJT plus LT on the first five days, SJT plus LT placebo on the last two days. Each group will be treated for seven days and followed-up 1-2 times. The primary outcome measures of effective rate and recurrence rate are symptoms. Secondary outcome measures of effective rate and recurrence rate are the urine leukocytes, bacteriology examination, and safety assessment. Outcomes will be assessed at baseline and after treatment. DISCUSSION: This study protocol will provide the research data of efficacy and safety of SJT for the treatment of acute uncomplicated lower UTI. The first aim is to determine whether Sanjin tablets can reduce the use of antibiotics; the second aim is to determine whether Sanjin tablets can substitute the use of antibiotics. The recurrence rate will be assessed after cured to determine whether SJT can reduce the recurrence rate. The results of this study will improve the rational use of drugs, especially the rational application of antibiotics. It will also enable safety evaluation from laboratory indices and adverse events, which will provide reliable evidence for clinical treatment.

trial registrationClinicalTrials.gov, NCT03658291 . Registered on 4 September 2018.

Indexed as

Administration, OralAdultAnti-Bacterial AgentsChinaDouble-Blind MethodDrugs, Chinese HerbalFemaleHumansLevofloxacinLower Urinary Tract SymptomsMaleMiddle AgedMulticenter Studies as TopicRandomized Controlled Trials as TopicTabletsTime FactorsAnti-Bacterial AgentsDrugs, Chinese HerbalLevofloxacinTabletsAcute uncomplicated UTIClinical trialsRandomized controlled trialSanjin tabletsSyndrome of dampness-heat in the lower jiao

Identifiers

PMID31324199
PMCPMC6642468
OpenAlexW2963745331

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.