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A trial will investigate the safety and efficacy of Qizhi Weitong granule
(QZWTG) when compared to the mosapride citrate tablet to treat functional
dyspepsia (FD) patients.
In FD patients, a trial will be conducted to investigate the safety and efficacy of QZWTG, a TCM (Traditional Chinese Medicine) preparation, and to compare the therapeutic effect of QZWTG compared with mosapride citrate tablet to relieve clinical symptoms of FD.
This randomized multicenter, double-blinded, double-placebo, positive drug parallel controlled clinical study will be conducted in eight hospitals. Overall, participants will be randomly allocated to either the experimental group (n=192) or the control group (n=192).
QZWTG and mosapride citrate tablet placebo will be administered to the experimental group. QZWTG placebo and mosapride citrate tablet will be administered to the control group. In FD patients, the safety and efficacy of QZWTG will be examined after four weeks of intervention and two weeks of follow-up.
Alteration in the main symptom score will be the primary outcome parameter. Advanced events, the change of the Hamilton anxiety scale and the Hamilton depression scale, and TCM syndrome evaluation will be the secondary outcome parameter.
Through the findings of blood and urine metabolomics, the study will investigate the biological mechanism of QZWTG in managing FD, and will thus aid to guide clinical practice. In December 2020, the trial is anticipated to be completed.
Medicine (Baltimore)
Clinical study on post evaluation after listing of Qizhi Weitong granules Study protocol clinical trial (SPIRIT compliant)
Lin Xu
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