Evidence map›Paper›PMID 33120757›Full record

ArticleMedicine2020

Yishentongluo decoction in treatment of idiopathic asthenozoospermia infertility: Study protocol for a randomized controlled trial.

Qi Zhang, Lipeng Fan, Fangyuan Li, Zixue Sun, Chenming Zhang, Rubing Chen

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.4field-weighted citation impact, top 31% 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

5 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. Article
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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

6 authors at 3 institutions in 1 country.

Qi ZhangCollege of Clinical Medicine, Chengdu University of Traditional Chinese Medicine, NO.37 Shi-er-qiao Road, Chengdu 610075, Sichuan Province, P.R. China; Chengdu University of Traditional Chinese Medicine Affiliated Hospital, NO.39 Shi-er-qiao Road, Chengdu 610075, Sichuan Province.
Lipeng FanDepartment of Reproductive Medicine, Henan Province Hospital of Traditional Chinese Medicine, NO.6 Dong-feng Road.
Fangyuan LiCollege of Clinical Medicine, Chengdu University of Traditional Chinese Medicine, NO.37 Shi-er-qiao Road, Chengdu 610075, Sichuan Province, P.R. China; Chengdu University of Traditional Chinese Medicine Affiliated Hospital, NO.39 Shi-er-qiao Road, Chengdu 610075, Sichuan Province.
Zixue SunSecond Clinical Medical School, Henan University of Chinese Medicine, NO.156 Jin-shui-dong Road.ORCID 0000-0002-3466-1056
Chenming ZhangSecond Clinical Medical School, Henan University of Chinese Medicine, NO.156 Jin-shui-dong Road.
Rubing ChenDepartment of Andrology, The First Affiliated Hospital of Henan University of Chinese Medicine, NO.19 Ren-min Road, Zhengzhou, Henan Province, P.R. China.
Science and Technology Department of Sichuan Province · CNFirst Affiliated Hospital of Henan University · CNShanxi Province Hospital of Traditional Chinese Medicine · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe reproductive dilemma faced by men has always been the focus of the whole society. Idiopathic asthenozoospermia (AZS), as one of the common causes of male infertility, lack of specific treatment. Traditional Chinese medicine has shown potential benefits in the management of male infertility. Yishentongluo decoction (YSTL) is a representative Chinese herbal formula; however, there is still no rigorous clinical trial supporting its application. Therefore, we designed a randomized controlled trial to evaluate the efficacy and safety of YSTL for patients with idiopathic AZS and explain the possible action mechanisms of YSTL in improving sperm motility.

methodsIn this randomized controlled study, a total of 160 eligible patients will be assigned to YSTL group or the Levocarnitine oral solution group in a 1:1 ratio. The treatment period will be 12 weeks and the follow-up period will last 4 weeks. The primary outcome will be the the progressive (motility), sperm rate (%). Secondary outcomes will include the progressive (motility) + non-progressive (motility) sperm rate(%), total effective sperm count, inner mitochondrial membrane potential (MMP) in spermatozoa, and spouse pregnancy rate (%). Safety outcomes will cover electrocardiogram , blood tests (including blood routine test, hepatic function, and renal function), urine routine test, and stool routine test. The semen parameters, sperm MMP test, and all the safety outcomes will be performed at the baseline, 4th, 8th and 12th week. The pregnancy outcome will be evaluated at 4 weeks after treatment. DISCUSSION: This study will provide initial evidence regarding the efficacy and safety of YSTL in the treatment of idiopathic AZS with kidney deficiency and blood stasis pattern. In addition, potential mechanisms of YSTL in improving sperm motility will be explored based on sperm MMP test.

trial registrationChinese Clinical Trials Register identifier, ChiCTR2000033290, registered on 26 May 2020.

Indexed as

AsthenozoospermiaDrugs, Chinese HerbalHumansMaleMedicine, Chinese TraditionalRandomized Controlled Trials as TopicSpermatozoaDrugs, Chinese Herbal

Identifiers

PMID33120757
PMCPMC7581134
OpenAlexW3093606688

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.