ArticleMedicine2020
Clinical study on post evaluation after listing of Qizhi Weitong granules: Study protocol clinical trial (SPIRIT compliant).
Article in Medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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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.
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.
Who cites it
2 citing papers in PubMed, 3 citations in OpenAlex.
- A comprehensive review of integrative pharmacology-based investigation: A paradigm shift in traditional Chinese medicine.Acta pharmaceutica Sinica. B · 2021Review
- Systematic Survey of the Alteration of the Faecal Microbiota in Rats With Gastrointestinal Disorder and Modulation by Multicomponent Drugs.Frontiers in pharmacology · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundFunctional dyspepsia (FD) is a highly prevalent functional gastrointestinal disorder which brings a significant impact on patients' quality of life. Although there are many available treatments to alleviate dyspepsia symptoms, most of them are far from satisfactory. Traditional Chinese medicine (TCM) has shown good potential in the treatment of FD, especially in terms of improving symptoms and adverse effects of Western medicine. Qizhi Weitong granule (QZWTG), a TCM preparation, has been utilized in treating FD for a long time and has achieved good clinical results. However, the existing evidence of its efficacy and mechanism of action is insufficient. Hence, the purpose of this study is to evaluate the efficacy and safety of QZWTG in the treatment of FD.
methodsThis study is a multicenter, randomized, double-blinded, double-placebo, positive drug parallel controlled clinical study. The experiment will be carried out in 8 hospitals at the same time, and a total of 384 cases of participants will be randomly assigned to the experimental group and the control group (n = 192). The experimental group will be given QZWTG and Mosapride citrate tablet placebo, and the control group will be given QZWTG placebo and Mosapride citrate tablet. After 4 weeks of intervention and 2 weeks of follow-up, the efficacy and safety of QZWTG in patients with FD will be observed. The primary outcomes are the change in the main symptom score. The secondary outcomes include TCM syndrome evaluation, the change of the Hamilton anxiety scale and the Hamilton depression scale, and advanced events. This study will explore the biological mechanism of QZWTG in the treatment of FD through the results of blood and urine metabolomics. DISCUSSION: This trial will provide first-hand evidence on whether QZWTG is noninferior to Mosapride citrate tablet. There will be a new option for the treatment of FD if noninferiority is set up. In addition, the efficacy and safety of QZWTG in the treatment of FD will be evaluated, and the mechanism of QZWTG in the treatment of FD will be explored through the metabolomics of blood and urine. On the other hand, as far as we know, this study may be the largest trial of efficacy and safety of QZWTG in the treatment of FD, which has important application value.
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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 Socratic graph.