Evidence map›Paper›PMID 33228726›Full record

ArticleTrials2020

Effects of Keluoxin capsule combined with losartan potassium on diabetic kidney disease: study protocol for a randomized double-blind placebo-controlled multicenter clinical trial.

Rui Wu, Fan Wei, Lianlian Qu, Litao Bai, Jun Li, Fei Li, Weitian Yan, Qiuhong Wang, Junping Wei

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
0.6field-weighted citation impact, top 30% 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, 2 syntheses or guidelines pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  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

9 authors at 3 institutions in 1 country.

Rui WuDepartment of Endocrinology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Xichen District, Beijing, 100053, China.
Fan WeiDermatological Department, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Xichen District, Beijing, 100053, China.
Lianlian QuDepartment of Endocrinology, Penglai Traditional Chinese Medicine Hospital, Penglai, 265600, Shandong, China.
Litao BaiDepartment of Integrated Chinese and Western Medicine, The Second Affiliated Hospital of Chongqing Medical University, Yuzhong District, Chongqing, 400010, China.
Jun LiDepartment of Endocrinology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Xichen District, Beijing, 100053, China.
Fei LiDepartment of Endocrinology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Xichen District, Beijing, 100053, China.
Weitian YanDepartment of Endocrinology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Xichen District, Beijing, 100053, China.
Qiuhong WangDepartment of Endocrinology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Xichen District, Beijing, 100053, China.
Junping WeiDepartment of Endocrinology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Xichen District, Beijing, 100053, China. weijunping@126.com.
Guang’anmen Hospital · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNChongqing Medical University · CN

Funding

Beijing Municipal Natural Science Foundation 7202172
6 · The paper itself

Abstract

backgroundDiabetic kidney disease (DKD) is one of the most important microvascular complications of diabetes, and its prevalence has increased dramatically in the past few decades. DKD is responsible for considerable morbidity and mortality of patients with diabetes. Keluoxin capsule (KLX) is a Chinese patent medicine that has been used in the clinic to control DKD for years. Previous studies have shown that KLX appears to reduce proteinuria, but the study protocols as well as the primary outcome need to be improved. Thus, we aim to evaluate whether losartan potassium combined with KLX is more effective than losartan potassium in DKD treatment and to provide validated evidence for the application of KLX in the treatment of DKD.

methodsWe will conduct a randomized double-blind placebo-controlled multicenter clinical trial. A total of 252 participants diagnosed with DKD recruited from 18 institutions will be randomly allocated to either a losartan potassium plus KLX (n = 126) or a losartan potassium plus placebo group (n = 126). The participants will be administered KLX or placebo in addition to losartan potassium for 24 weeks. The primary outcome measure will be the decline in estimated glomerular filtration rate (eGFR) (ml/min/1.73 m DISCUSSION: This study will be the first randomized clinical trial to evaluate the efficacy and safety of KLX versus the placebo for the treatment of patients with DKD. The outcome of this trial will provide a basis for prescribing KLX to patients with DKD.

trial registrationChinese Clinical Trial Registry ( www.chictr.org.cn ) ChiCTR1900021113. Registered on January 29, 2019.

Indexed as

Diabetes MellitusDiabetic NephropathiesDrugs, Chinese HerbalDouble-Blind MethodGlomerular Filtration RateHumansLosartanMulticenter Studies as TopicRandomized Controlled Trials as TopicTreatment OutcomeDrugs, Chinese HerbalLosartanChinese medicineDiabetic kidney diseaseProtocolRandomized controlled trial

Identifiers

PMID33228726
PMCPMC7682004
OpenAlexW3110582749

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.