AI Article Synopsis
- - The study investigates the Qishe pill, a traditional Chinese medicine (TCM), focusing on its use for treating neck pain by analyzing how its effectiveness varies among individuals with different constitution types (Qi-Deficiency, Yin-Deficiency, and Blood-Stasis).
- - It examines the pharmacokinetic profile of the Qishe pill among healthy subjects by categorizing them into groups based on their constitutional types, and subjects will receive different doses for analysis.
- - Advanced techniques such as next-generation sequencing and multiomics are employed to assess the pill’s impact, aiming to enhance the standardization and personalization of TCM therapies.
Article Abstract
Background: 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.
Methods/design: 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.
Trial Registration: This study is registered at ClinicalTrials.gov, NCT02294448 .15 November 2014.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4351929 | PMC |
| http://dx.doi.org/10.1186/s13063-015-0568-6 | DOI Listing |
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Article Synopsis
- - The study investigates the Qishe pill, a traditional Chinese medicine (TCM), focusing on its use for treating neck pain by analyzing how its effectiveness varies among individuals with different constitution types (Qi-Deficiency, Yin-Deficiency, and Blood-Stasis).
- - It examines the pharmacokinetic profile of the Qishe pill among healthy subjects by categorizing them into groups based on their constitutional types, and subjects will receive different doses for analysis.
- - Advanced techniques such as next-generation sequencing and multiomics are employed to assess the pill’s impact, aiming to enhance the standardization and personalization of TCM therapies.
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