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Population pharmacokinetic modeling of the Qishe pill in three major traditional Chinese medicine-defined constitutional types of healthy Chinese subjects: study protocol for a randomized controlled…

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Title
Population pharmacokinetic modeling of the Qishe pill in three major traditional Chinese medicine-defined constitutional types of healthy Chinese subjects: study protocol for a randomized controlled trial
Published in
Trials, February 2015
DOI 10.1186/s13063-015-0568-6
Pubmed ID
Authors

Yue-li Sun, Ting Hou, Shu-fen Liu, Zhong-liang Zhang, Ning Zhang, Min Yao, Long Yang, Qi Shi, Xue-jun Cui, Yong-jun Wang

Abstract

High incidences of neck pain morbidity are challenging in various situations for populations based on their demographic, physiological and pathological characteristics. Chinese proprietary herbal medicines, as Complementary and Alternative Medicine (CAM) products, are usually developed from well-established and long-standing recipes formulated as tablets or capsules. However, good quantification and strict standardization are still needed for implementation of individualized therapies. The Qishe pill was developed and has been used clinically since 2009. The Qishe pill's personalized medicine should be documented and administered to various patients according to the ancient TCM system, a classification of personalized constitution types, established to determine predisposition and prognosis to diseases as well as therapy and life-style administration. Therefore, we describe the population pharmacokinetic profile of the Qishe pill and compare its metabolic rate in the three major constitution types (Qi-Deficiency, Yin-Deficiency and Blood-Stasis) to address major challenges to individualized standardized TCM. Healthy subjects (N = 108) selected based on constitutional types will be assessed, and standardized pharmacokinetic protocol will be used for assessing demographic, physiological, and pathological data. Laboratory biomarkers will be evaluated and blood samples collected for pharmacokinetics(PK) analysis and second-generation gene sequencing. In single-dose administrations, subjects in each constitutional type cohort (N = 36) will be randomly divided into three groups to receive different Qishe pill doses (3.75, 7.5 and 15 grams). Multiomics, including next generation sequencing, metabolomics, and proteomics, will complement the Qishe pill's multilevel assessment, with cytochrome P450 genes as targets. In a comparison with the general population, a systematic population pharmacokinetic (PopPK) model for the Qishe pill will be established and verified. This study is registered at ClinicalTrials.gov, NCT02294448 .15 November 2014.

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Mendeley readers

The data shown below were compiled from readership statistics for 57 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 57 100%

Demographic breakdown

Readers by professional status Count As %
Researcher 10 18%
Student > Master 8 14%
Student > Bachelor 8 14%
Student > Ph. D. Student 7 12%
Other 4 7%
Other 8 14%
Unknown 12 21%
Readers by discipline Count As %
Medicine and Dentistry 17 30%
Nursing and Health Professions 6 11%
Agricultural and Biological Sciences 3 5%
Biochemistry, Genetics and Molecular Biology 3 5%
Pharmacology, Toxicology and Pharmaceutical Science 2 4%
Other 12 21%
Unknown 14 25%