Evidence map›Paper›PMID 28395659›Full record

Trial reportTrials2017

Abelmoschus manihot - a traditional Chinese medicine versus losartan potassium for treating IgA nephropathy: study protocol for a randomized controlled trial.

Ping Li, Yi-Zhi Chen, Hong-Li Lin, Zhao-Hui Ni, Yong-Li Zhan, Rong Wang, Hong-Tao Yang, Jing-Ai Fang, Nian-Song Wang, Wen-Ge Li and 2 more

Registry-linked trialOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02231125 (Efficacy and Safety of Abelmoschus Manihot for IgA Nephropathy), which is not on this map. Cited by 21 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 4 pooled it
4.1field-weighted citation impact, top 7% 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.

NCT02231125 phase4unknown statusnot on this map

Efficacy and Safety of Abelmoschus Manihot for IgA Nephropathy: a Multicentre, Double-blind, Double-dummy, Randomized Controlled Trial

TypeinterventionalSponsorChen XiangmeiRan2014 to 2017Enrolled1,600ConditionsIgA NephropathyArmsLosartan, Abelmoschus manihot
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 4 syntheses or guidelines pooled it, 32 citations in OpenAlex.

  1. Pooled it
  2. Non-immunosuppressive treatment for IgA nephropathy.The Cochrane database of systematic reviews · 2024
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Article
  6. Article
  7. Therapeutic potential ofFrontiers in pharmacology · 2025
    Review
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  9. Effects ofFrontiers in pharmacology · 2024
    Article
  10. Article
  11. Evaluation of the efficacy ofFrontiers in pharmacology · 2023
    Article
  12. Article
  13. Article
  14. Review
  15. Okra (Molecules (Basel, Switzerland) · 2021
    Review
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  18. Review
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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 10 institutions in 1 country.

Ping LiDepartment of Nephrology, State Key Laboratory of Kidney Disease, 2011DAV00088, Chinese PLA General Hospital, Beijing, 100853, China.
Yi-Zhi ChenDepartment of Nephrology, State Key Laboratory of Kidney Disease, 2011DAV00088, Chinese PLA General Hospital, Beijing, 100853, China.
Hong-Li LinDepartment of Nephrology, The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, 116011, China.
Zhao-Hui NiDepartment of Nephrology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200127, China.
Yong-Li ZhanDepartment of Nephrology, Guang' anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China.
Rong WangDepartment of Nephrology, Shandong Provincial Hospital, Jinan, 250021, China.
Hong-Tao YangDepartment of Nephrology, First Teaching Hospital of Tianjin University of TCM, Tianjin, 300192, China.
Jing-Ai FangDepartment of Nephrology, The First Hospital of Shanxi Medical University, Taiyuan, 030024, China.
Nian-Song WangDepartment of Nephrology, The Sixth Affiliated Hospital of Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, China.
Wen-Ge LiDepartment of Nephrology, China-Japan Friendship Hospital, Beijing, 100029, China.
Xue-Feng SunDepartment of Nephrology, State Key Laboratory of Kidney Disease, 2011DAV00088, Chinese PLA General Hospital, Beijing, 100853, China. xfssun@126.com.
Xiang-Mei ChenDepartment of Nephrology, State Key Laboratory of Kidney Disease, 2011DAV00088, Chinese PLA General Hospital, Beijing, 100853, China. xmchen301@126.com.
Chinese PLA General Hospital · CNChina-Japan Friendship Hospital · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNFirst Affiliated Hospital of Dalian Medical University · CNShandong Provincial Hospital · CNShanghai Jiao Tong University · CNShanghai Sixth People's Hospital · CNShanxi Medical University · CNState Key Laboratory of Kidney DiseasesTianjin University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIgA nephropathy (IgAN) is one of the most common primary glomerular diseases worldwide, but effective therapy remains limited and many patients progress to end-stage renal disease (ESRD). Only angiotensin-converting enzyme inhibitors (ACE-I)/angiotensin-receptor blockers (ARB) show a high level of evidence (1B level) of being of value in the treatment for IgAN according to the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. However, traditional Chinese medicine has raised attention in kidney disease research. Abelmoschus manihot, a single medicament of traditional Chinese medicine has shown therapeutic effects in primary glomerular disease according to the randomized controlled clinical trial that we have completed. Here, we conduct a new study to assess the efficacy and safety of Abelmoschus manihot in IgAN. Also, this study is currently the largest double-blind, randomized controlled registered clinical research for the treatment of IgAN.

methodsWe will conduct a multicenter, prospective, double-blind, double-dummy randomized controlled study. The study is designed as a noninferiority clinical trial. Approximately 1600 biopsy-proven IgAN patients will be enrolled at 100 centers in China and followed up for as long as 48 weeks. IgAN patients will be randomized assigned to the Abelmoschus manihot group (in the form of a huangkui capsule, 2.5 g, three times per day) and the losartan potassium group (losartan potassium, 100 mg/d). The primary outcome is the change in 24-h proteinuria from baseline after 48 weeks of treatment. Change in estimated glomerular filtration rate (eGFR) from baseline after 48 weeks of treatment, the incidence of endpoint events (proteinuria ≥3.5 g/24 h, the doubling of serum creatinine, or receiving blood purification treatment) are the secondary outcomes. Twenty-four-hour proteinuria and eGFR are measured at 0, 4, 12, 24, 36 and 48 weeks. DISCUSSION: This study will be of sufficient size and scope to evaluate the efficacy and safety of Abelmoschus manihot compared to losartan potassium in treating patients with IgAN. The results of this study may provide a new, effective and safe treatment strategy for IgAN.

trial registrationClinicalTrials.gov, identifier: NCT02231125 . Registered on 30 August 2014.

Indexed as

AbelmoschusClinical ProtocolsMedicine, Chinese TraditionalAdolescentAdultAgedAngiotensin II Type 1 Receptor BlockersDouble-Blind MethodGlomerulonephritis, IGAHumansLosartanMiddle AgedOutcome Assessment, Health CareProspective StudiesYoung AdultAngiotensin II Type 1 Receptor BlockersLosartanAbelmoschus manihotIgA nephropathyRandomized controlled studyTraditional Chinese medicine

Identifiers

PMID28395659
PMCPMC5387231
OpenAlexW2605514358

What OpenQuestion holds

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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.