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| Reflections on key elements of clinical trial design for innovative Chinese medicine compound formulations：Insights from practice with category 1.1 Chinese compound preparations |
| Hits 559 Download times 125 Received:October 11, 2025 |
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| DOI
10.11656/j.issn.1672-1519.2026.01.12 |
| Key Words
innovative Chinese medicine;clinical trial;key elements |
| Author Name | Affiliation | E-mail | | ZHOU Qiang | Tasly Pharmaceutical Group Co., Ltd., State Key Laboratory of Modern Chinese Medicine Creation, Tianjin Key Laboratory of Component-based Chinese Medicine, Tianjin 300410, China | | | YANG Fengwen | Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | PANG Wentai | Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | HAN Meizi | Tasly Pharmaceutical Group Co., Ltd., State Key Laboratory of Modern Chinese Medicine Creation, Tianjin Key Laboratory of Component-based Chinese Medicine, Tianjin 300410, China | | | CHEN Zheng | Tasly Pharmaceutical Group Co., Ltd., State Key Laboratory of Modern Chinese Medicine Creation, Tianjin Key Laboratory of Component-based Chinese Medicine, Tianjin 300410, China | | | WANG Shuo | Tasly Pharmaceutical Group Co., Ltd., State Key Laboratory of Modern Chinese Medicine Creation, Tianjin Key Laboratory of Component-based Chinese Medicine, Tianjin 300410, China | | | WU Lingbing | Tasly Pharmaceutical Group Co., Ltd., State Key Laboratory of Modern Chinese Medicine Creation, Tianjin Key Laboratory of Component-based Chinese Medicine, Tianjin 300410, China | | | ZHENG Yuhong | Tasly Pharmaceutical Group Co., Ltd., State Key Laboratory of Modern Chinese Medicine Creation, Tianjin Key Laboratory of Component-based Chinese Medicine, Tianjin 300410, China | | | LIU Rui | Tasly Pharmaceutical Group Co., Ltd., State Key Laboratory of Modern Chinese Medicine Creation, Tianjin Key Laboratory of Component-based Chinese Medicine, Tianjin 300410, China | | | LI Dekun | Tasly Pharmaceutical Group Co., Ltd., State Key Laboratory of Modern Chinese Medicine Creation, Tianjin Key Laboratory of Component-based Chinese Medicine, Tianjin 300410, China | | | ZHOU Shuiping | Tasly Pharmaceutical Group Co., Ltd., State Key Laboratory of Modern Chinese Medicine Creation, Tianjin Key Laboratory of Component-based Chinese Medicine, Tianjin 300410, China | zhoushuiping5@taslypharma.com |
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| Abstract
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| Focusing on the design challenges of phase Ⅰ-Ⅲ trials for innovative 1.1-class Chinese-compound medicines，this article uses Anshen Dripping Pills，Antiwei Granules，Qingzhu Granules and Qishen Yiqi Dripping Pills as case studies to systematize five pivotal elements：“theory，population，treatment duration，end-points and dosage”，1）syndrome-based differentiation is employed to pinpoint the target population and achieve a precise“formula-syndrome-patient”match；2）stratification by baseline disease severity and the introduction of a placebo run-in/wash-out phase mitigate placebo effects and residual-drug interference；3）acute conditions are evaluated within the 24 h to 72 h“golden window”，whereas chronic diseases adopt a staged-treatment strategy with optimal durations； 4）a multi-dimensional“disease-syndrome-symptom”endpoint system that combines patient-reported outcomes，traditional Chinese medicine syndrome scores and hard clinical outcomes highlights the holistic benefits of herbal therapy；5）comprehensive phase Ⅱ dose-finding reveals non-linear dose-response relationships，while classical principles such as“sovereign-minister-assistant-courier” and“three-factor tailoring”anchor the minimal effective dose. The paper advocates moving beyond a chemical-drug mindset： “synergistic assault”to break through efficacy ceilings and“value extension”to fill unmet therapeutic gaps，offering a replicable and scalable clinical-trial paradigm for innovative Chinese-compound medicines. |
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